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1 | Thanks to Maz for his efforts in putting this workbook together. Be sure to follow @Mazeraski on Twitter. This spreadsheet was last published on 2022-05-30 11:24:49. | ||||||||||||||||||||||||||
2 | # | Ticker | Collaborator(s) | Presentation Type | ASCO Session Title | ASCO Subtrack Name | Abstract Title | Clinical Trial Page | Clinical Trial Study Title | Conditions | Treatments | Phase | Overall Status | Enrollment | Trial Masking | Primary Endpoints | Secondary Endpoints | ||||||||||
3 | 1 | AADI | Poster Session | Sarcoma | Sarcoma | nab-Sirolimus for patients with advanced malignant PEComa with or without prior mTOR inhibitors: Biomarker results from AMPECT and an expanded access program. | NCT02494570 | A Phase 2 Study of ABI-009 in Patients With Advanced Malignant PEComa A Phase 2 Multi-center Investigation of Efficacy of ABI-009 (Nab-sirolimus) in Patients With Advanced Malignant Perivascular Epithelioid Cell Tumors (PEComa) | - PEComa | - ABI-009 | Phase 2 | Completed | 34 (Actual) | None (Open Label) | - objective response rate | - Duration of response - Progression free rate at 6 months - Progression free survival - Overall survival - Number of participants with Adverse events | |||||||||||
4 | 2 | ABBV | Publication Only | Breast Cancer Metastatic | Breast Cancer | Risk of seizures in a population of women with BRCA-positive metastatic breast cancer in the United States. | |||||||||||||||||||||
5 | 3 | ABBV | Poster Session | Hematologic Malignancies Leukemia, Myelodysplastic Syndromes, and Allotransplant | Hematologic Malignancies | Lemzoparlimab (lemzo) with venetoclax (ven) and/or azacitidine (aza) in patients (pts) with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS): A phase 1b dose escalation study. | NCT04912063 | Study to Evaluate Adverse Events and Movement of Lemzoparlimab in Body When Used Intravenously (IV) With Azacitidine Subcutaneously or IV and Venetoclax Orally in Participants With Acute Myeloid Leukemia and With Azacitidine With or Without Venetoclax in Participants With Myelodysplastic Syndrome A Phase 1b Dose Escalation Study of Lemzoparlimab in Combination With Venetoclax and/or Azacitidine in Subjects With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) | - Acute Myeloid Leukemia (AML) - Myelodysplastic Syndrome (MDS) | - Lemzoparlimab - Azacitidine - Venetoclax | Phase 1 | Recruiting | 80 (Anticipated) | None (Open Label) | - Dose Limiting Toxicities (DLTs) of Lemzoparlimab (TJ011133) When Co-administered With Venetoclax and Azacitidine in Participants With Treatment-Naïve Acute Myeloid Leukemia (AML) Ineligible for Standard Induction Therapy - DLTs of Lemzoparlimab (TJ011133) When Co-administered With Azacitidine With or Without Venetoclax in Participants With Treatment-Naïve Higher-Risk Myelodysplastic Syndrome (MDS) - Dose Limiting Toxicities (DLTs) of Lemzoparlimab (TJ011133) as a Monotherapy in Japanese Participants with Relapsed/Refractory (R/R) AML - DLTs of Lemzoparlimab (TJ011133) as a Monotherapy in Japanese Participants with R/R MDS | - Best Overall Response of Complete Remission (CR) for AML - Best Overall Response of Composite CR (CRc) for AML - Best Overall Response of CR or Complete Remission With Partial Hematologic Recovery (CRh) for AML - Duration of Response (DOR) for AML - Event-Free Survival (EFS) for AML - Overall Survival (OS ) for AML - Best Overall Response of CR, for MDS - Best Overall Response of Marrow-Complete Remission (mCR), for MDS (See clinicaltrials.gov for the complete list of secondary endpoints.) | |||||||||||
6 | 4 | ABBV | Poster Session | Lung Cancer Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers | Lung Cancer | Genomic analysis and prediction of therapeutic vulnerabilities of small cell lung cancer from rovalpituzumab tesirine phase III trial (MERU). | |||||||||||||||||||||
7 | 5 | ABBV | TAK, GSK, KPTI | Poster Session | Hematologic Malignancies Plasma Cell Dyscrasia | Hematologic Malignancies | Myeloma developing regimens using genomics (MyDRUG) trial: Results from the RAS mutation targeting arm. | NCT03732703 | Myeloma-Developing Regimens Using Genomics (MyDRUG) Myeloma-Developing Regimens Using Genomics (MyDRUG) (Genomics Guided Multi-arm Trial of Targeted Agents Alone or in Combination With a Backbone Regimen) | - Relapsed Refractory Multiple Myeloma | - Abemaciclib, dexamethasone, ixazomib, pomalidomide - Enasidenib, dexamethasone, ixazomib, pomalidomide - Cobimetinib, dexamethasone, ixazomib, pomalidomide - Erdafitinib, dexamethasone, ixazomib, pomalidomide - Venetoclax, dexamethasone, ixazomib, pomalidomide - Daratumumab, dexamethasone, ixazomib, pomalidomide - Belantamab mafodotin, dexamethasone, ixazomib, pomalidomide - Selinexor, dexamethasone, ixazomib, pomalidomide | Phase 1/Phase 2 | Recruiting | 228 (Anticipated) | None (Open Label) | - Overall Response Rate - Actionable Genetic Alteration - Overall Response Rate - Non-Actionable Genetic Alteration | |||||||||||
8 | 6 | ABBV | Publication Only | Health Services Research and Quality Improvement | Health Services Research and Quality Improvement | Real-world evidence on predictors of survival for hormone-positive and triple-negative advanced breast cancer by treatment and BRCA status in the United States. | |||||||||||||||||||||
9 | 7 | ABBV | Poster Session | Central Nervous System Tumors | Central Nervous System Tumors | GBM AGILE: A global, phase 2/3 adaptive platform trial to evaluate multiple regimens in newly diagnosed and recurrent glioblastoma. | NCT03970447 | A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma GBM AGILE: Global Adaptive Trial Master Protocol: An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent GBM | - Glioblastoma | - Temozolomide - Lomustine - Regorafenib - Radiation - Paxalisib - VAL-083 | Phase 2/Phase 3 | Recruiting | 1030 (Anticipated) | None (Open Label) | - Overall Survival (OS) | - Progression-free survival (PFS) - Tumor Response - Duration of Response (CR + PR) | |||||||||||
10 | 8 | ABBV | Poster Discussion Session | Hematologic Malignancies Lymphoma and Chronic Lymphocytic Leukemia | Hematologic Malignancies | Fixed-duration (FD) ibrutinib (I) + venetoclax (V) for first-line (1L) treatment (tx) of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): Three-year follow-up from the FD cohort of the phase 2 CAPTIVATE study. | NCT02910583 | Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL) Phase 2 Study of the Combination of Ibrutinib Plus Venetoclax in Subjects With Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | - Leukemia - Chronic Lymphocytic Leukemia - Small Lymphocytic Lymphoma | - ibrutinib - venetoclax - Placebo | Phase 2 | Active, not recruiting | 323 (Actual) | Triple | - MRD Cohort: 1-Year Disease-Free Survival (DFS) Rate in Confirmed uMRD Randomized Participants - FD Cohort: Complete Response Rate (CRR; Complete Response/Complete Response With Incomplete Blood Count Recovery [CR/CRi]) Rate | - MRD Cohort: CRR (CR/CRi Rate) - MRD Cohort: Overall Response Rate (ORR) - MRD Cohort: Duration of Response (DOR) - MRD Cohort: MRD-Negativity Rate (MRR) - MRD Cohort: Tumor Lysis Syndrome (TLS) Risk Reduction Rate With 3-Cycle Ibrutinib Lead-In (Percentage of Participants No Longer High Risk After 3-cycle Lead-in) - MRD Cohort: Kaplan-Meier Estimate of Progression Free Survival (PFS) Rate at 36 Months Landmark Time - MRD Cohort: Kaplan-Meier Estimate of Overall Survival (OS) Rate at 36 Months Landmark Time - MRD Cohort: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Discontinuations Due to TEAEs (See clinicaltrials.gov for the complete list of secondary endpoints.) | |||||||||||
11 | 9 | ABBV | Poster Discussion Session | Hematologic Malignancies Leukemia, Myelodysplastic Syndromes, and Allotransplant | Hematologic Malignancies | Navitoclax plus ruxolitinib in JAK inhibitor-naive patients with myelofibrosis: Preliminary safety and efficacy in a multicenter, open-label phase 2 study. | NCT03222609 | A Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Participants With Myelofibrosis A Phase 2 Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Subjects With Myelofibrosis (REFINE) | - Myelofibrosis (MF) | - Ruxolitinib - Navitoclax | Phase 2 | Active, not recruiting | 191 (Actual) | None (Open Label) | - Percentage of Participants who achieve Spleen Volume Reduction of greater than or equal to 35% (SVR35) from baseline | - Percentage of participants achieving 50% Reduction in Total System Score (TSS) - Anemia Response - Change in Grade of Bone Marrow Fibrosis | |||||||||||
12 | 10 | ABBV | Poster Discussion Session | Lung Cancer Non-Small Cell Metastatic | Lung Cancer | Phase 1/1b study of telisotuzumab vedotin (Teliso-V) + osimertinib (Osi), after failure on prior Osi, in patients with advanced, c-Met overexpressing, EGFR-mutated non-small cell lung cancer (NSCLC). | NCT02099058 | A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumors A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-399, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors | - Advanced Solid Tumors Cancer | - Osimertinib - Nivolumab - Telisotuzumab vedotin - Erlotinib | Phase 1 | Recruiting | 260 (Anticipated) | None (Open Label) | - Number of Participants with Adverse Events - Recommended Phase 2 Dose (RPTD) of ABBV-399 when Administered as Monotherapy and in Combination with Osimertinib, Erlotinib or Nivolumab - Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t) - Maximum observed plasma concentration (Cmax) - Time to Cmax (Tmax) - Terminal elimination half life | ||||||||||||
13 | 11 | ABBV | Poster Discussion Session | Lung Cancer Non-Small Cell Metastatic | Lung Cancer | Telisotuzumab vedotin (Teliso-V) monotherapy in patients (pts) with previously treated c-Met overexpressing (OE) advanced non-small cell lung cancer (NSCLC). | NCT03539536 | Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects With Previously Treated c-Met+ Non-Small Cell Lung Cancer | - Non-small Cell Lung Cancer | - Telisotuzumab vedotin | Phase 2 | Recruiting | 310 (Anticipated) | None (Open Label) | - Overall Response Rate (ORR) | - Duration of Response (DoR) - Disease Control Rate (DCR) - Progression-Free Survival (PFS) - Overall Survival (OS) | |||||||||||
14 | 12 | ABBV | Poster Session | Hematologic Malignancies Leukemia, Myelodysplastic Syndromes, and Allotransplant | Hematologic Malignancies | Efficacy and safety of venetoclax in combination with azacitidine or decitabine in an outpatient setting in patients with untreated acute myeloid leukemia. | NCT03941964 | A Study of the Effectiveness of Venetoclax in Combination With Azacitidine or Decitabine in an Outpatient Setting in Patients With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy A Phase 3b, Single-Arm, Multicenter Open-Label Study of Venetoclax in Combination With Azacitidine or Decitabine in an Outpatient Setting in AML Patients Ineligible for Intensive Chemotherapy | - Acute Myeloid Leukemia (AML) - Cancer | - venetoclax - azacytidine - decitabine | Phase 3 | Active, not recruiting | 54 (Actual) | None (Open Label) | - Composite Complete Remission Rate (CR + CRi) | - Overall Response Rates (CR, CRi) - Percent of Participants who Achieve Transfusion Independence | |||||||||||
15 | 13 | ABUS | Publication Only | Developmental Therapeutics Immunotherapy | Developmental Therapeutics Immunotherapy | Preclinical anti-tumor activity of small-molecule oral PD-L1 checkpoint inhibitors. | |||||||||||||||||||||
16 | 14 | ACET | Clinical Science Symposium | Beating Bad Blood: The Power of Immunotherapy in Hematologic Malignancies | Hematologic Malignancies | A phase 1 study of ADI-001: Anti-CD20 CAR-engineered allogeneic gamma delta ( ) T cells in adults with B-cell malignancies. | NCT04735471 | A Study of ADI-001 in B Cell Malignancies A Phase 1 Safety and Efficacy Study of ADI-001 Anti-CD20 CAR-engineered Allogeneic Gamma Delta T Cells in Adults With B Cell Malignancies, in Monotherapy and Combination With IL 2 | - Lymphoma, Follicular - Lymphoma, Mantle-Cell - Marginal Zone Lymphoma - Lymphoma, Burkitt - Mediastinal Lymphoma - Diffuse Large B Cell Lymphoma - Lymphoma, Non-Hodgkin - Lymphoma, Large B-Cell, Diffuse | - ADI-001 - Fludarabine - Cyclophosphamide - Bendamustine - Interleukin-2 | Phase 1 | Recruiting | 76 (Anticipated) | None (Open Label) | - The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort - Proportion of treatment emergent and treatment related adverse events | - Duration of ADI-001 persistence - Overall Response Rate by Lugano Criteria - Duration of Response by Lugano Criteria - Progression Free Survival by Lugano Criteria - Time To Progression by Lugano Criteria - Overall Survival by Lugano Criteria | |||||||||||
17 | 15 | ACLX | DTIL | Oral Abstract Session | Hematologic Malignancies Plasma Cell Dyscrasia | Hematologic Malignancies | Phase 1 study of CART-ddBCMA in relapsed or refractory multiple myeloma. | NCT04155749 | Master Protocol for the Phase 1 Study of Cell Therapies in Multiple Myeloma Master Protocol for the Phase 1 Study of Cell Therapies for the Treatment of Patients With Relapsed Refractory Multiple Myeloma, Including Long-term Safety Follow-up | - Relapsed and Refractory Multiple Myeloma | - CART-ddBCMA - ARC-T Plus Anti-BCMA SparX | Phase 1 | Recruiting | 65 (Anticipated) | None (Open Label) | - Incidence of treatment-emergent adverse events (TEAEs), including DLT(s) - Establish the RP2D of the investigational agent | - Best overall response (BOR) by IMWG Consensus Criteria - ORR by IMWG Consensus Criteria - In vivo pharmacokinetics | ||||||||||
18 | 16 | ADAG | Publication Only | Gynecologic Cancer | Gynecologic Cancer | Phase 1 study of ADG126, a novel masked anti-CTLA-4 SAFEbody, that combines tumor-localized activation with strong Treg depletion and soft ligand blocking in patients with advanced solid tumors. | NCT04645069 | ADG126, ADG126 in Combination With Toripalimab, and ADG126 in Combination With ADG106 in Advanced/Metastatic Solid Tumors A First-in-Human (FIH), Open-Label, Phase I Dose Escalation and Expansion Study of ADG126, ADG126 in Combination With Toripalimab, and ADG126 in Combination With ADG106 in Patients With Advanced/Metastatic Solid Tumors | - Advanced/Metastatic Solid Tumors | - ADG126 Mono - ADG126-anti PD1 - ADG126-ADG106 | Phase 1 | Recruiting | 146 (Anticipated) | None (Open Label) | - Number of participants experiencing dose-limiting toxicities escalating dose levels in adults with advanced / metastatic solid tumors - Number of participants with adverse events as assessed by CTCAE v5.0 ADG126-ADG106 combination regimens | - Antidrug antibodies (ADAs) - Area under the time concentration curve (AUC) from time zero to infinity (AUC0-inf) - Maximum (peak) plasma concentration (Cmax) - Time to maximum (peak) plasma concentration (Tmax) - Trough plasma concentration (Ctrough) | |||||||||||
19 | 17 | ADAP | Poster Session | Sarcoma | Sarcoma | Identification of response stratification factors from pooled efficacy analyses of afamitresgene autoleucel ( Afami-cel [Formerly ADP-A2M4]) in metastatic synovial sarcoma and myxoid/round cell liposarcoma phase 1 and phase 2 trials. | NCT04044768 | Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma A Phase 2 Single Arm Open-Label Clinical Trial of ADP-A2M4 SPEARâ„¢ T Cells in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma | - Synovial Sarcoma - Myxoid Liposarcoma | - afamitresgene autoleucel (previously ADP-A2M4) | Phase 2 | Recruiting | 90 (Anticipated) | None (Open Label) | - Efficacy: Overall Response Rate (ORR) | - Number of subjects with treatment -related adverse events (AEs), including serious adverse events (SAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 - Evaluate safety of ADP-A2M4 through measurement of Replication -competent Retrovirus in genetically engineered T-cells - Measurement of T-cell clonality and insertional oncogenesis in peripheral blood mononuclear cells (PBMCs). - Efficacy: Best overall response (BOR) - Time to response (TTR) - Duration of Response (DoR) - Progression Free Survival (PFS) - Overall Survival (OS) (See clinicaltrials.gov for the complete list of secondary endpoints.) | |||||||||||
20 | 18 | ADCT | Poster Session | Developmental Therapeutics Molecularly Targeted Agents and Tumor Biology | Developmental Therapeutics Molecularly Targeted Agents and Tumor Biology | First-in-human, phase 1, open-label, dose-escalation, dose-expansion study of ADCT-901 as monotherapy in patients with select advanced solid tumors. | NCT04972981 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-901 in Participants With Selected Advanced Solid Tumors A Phase 1, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-901 as Monotherapy in Patients With Selected Advanced Solid Tumors | - Advanced Solid Tumors | - ADCT-901 | Phase 1 | Recruiting | 76 (Anticipated) | None (Open Label) | - Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) - Number of Participants Who Experience a Dose Interruption - Number of Participants Who Experience a Dose Reduction - Number of Participants Who Experience a Dose Limiting Toxicity (DLT) During the Dose-Escalation Phase | - Overall Response Rate (ORR) - Duration of Response (DOR) - Progression-Free Survival (PFS) - Overall Survival (OS) - Maximum Concentration (Cmax) of ADCT-901 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum - Time to Maximum Concentration (Tmax) of ADCT-901 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum - Area Under the Concentration-Time Curve From Time Zero to the End of the Dosing Interval (AUClast) of ADCT-901 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum - Area Under the Concentration-Time Curve From Time Zero to the End of the Dosing Interval (AUCtau) of ADCT-901 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum (See clinicaltrials.gov for the complete list of secondary endpoints.) | |||||||||||
21 | 19 | ADCT | Poster Session | Hematologic Malignancies Lymphoma and Chronic Lymphocytic Leukemia | Hematologic Malignancies | Phase 3 randomized study of loncastuximab tesirine in combination with rituximab (Lonca-R) versus immunochemotherapy in patients with R/R DLBCL (LOTIS-5). | NCT04384484 | Study to Evaluate Loncastuximab Tesirine With Rituximab Versus Immunochemotherapy in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma A Phase 3 Randomized Study of Loncastuximab Tesirine Combined With Rituximab Versus Immunochemotherapy in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (LOTIS-5) | - Relapsed Diffuse Large B-Cell Lymphoma - Refractory Diffuse Large B-Cell Lymphoma | - Loncastuximab Tesirine - Rituximab - Gemcitabine - Oxaliplatin | Phase 3 | Recruiting | 350 (Anticipated) | None (Open Label) | - Progression-free Survival (PFS) | - Overall Survival (OS) - Overall Response Rate (ORR) - Complete Response Rate (CRR) - Duration of Response (DOR) - Number of Participants Who Experience At Least One Treatment-Emergent Adverse Event (TEAE) - Number of Participants Who Experience At Least One Serious Adverse Event (SAE) - Number of Participants Who Experience a Clinically Significant Change From Baseline in Clinical Laboratory Results - Number of Participants Who Experience a Clinically Significant Change From Baseline in Vital Sign Measurements (See clinicaltrials.gov for the complete list of secondary endpoints.) | |||||||||||
22 | 20 | ADCT | Publication Only | Hematologic Malignancies Lymphoma and Chronic Lymphocytic Leukemia | Hematologic Malignancies | Long-term survival projections of loncastuximab tesirine-treated patients in relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). | |||||||||||||||||||||
23 | 21 | ADPT | Poster Session | Pediatric Oncology | Pediatric Oncology | Minimal residual disease comparison between Ig/TCR PCR versus NGS assays in children with Philadelphia chromosome-positive acute lymphoblastic leukemia:Â A report from the COG AALL1631 study. | |||||||||||||||||||||
24 | 22 | ADPT | Poster Session | Hematologic Malignancies Lymphoma and Chronic Lymphocytic Leukemia | Hematologic Malignancies | Molecular disease monitoring in patients with relapsed/refractory B-cell non-Hodgkin lymphoma receiving anti-CD19 CAR T-cell therapy. | |||||||||||||||||||||
25 | 23 | ADXS | Poster Session | Genitourinary Cancer Prostate, Testicular, and Penile | Genitourinary Cancer Prostate, Testicular, and Penile | A phase I study of ADXS-504, a cancer type specific immunotherapy, for patients with biochemically recurrent prostate cancer. | NCT05077098 | Study of ADXS-504 Immunotherapy for Recurrent Prostate Cancer A Phase 1 Study of ADXS-504, a Cancer Type Specific Immunotherapy, With Biochemically Recurrent Prostate Cancer | - Recurrent Prostate Cancer | - ADXS-504 | Phase 1 | Recruiting | 21 (Anticipated) | None (Open Label) | - Safety and tolerability profile of ADXS-504 assessed by rates of treatment-related adverse events (AEs), graded by CTCAE v5.0 | ||||||||||||
26 | 24 | ADXS | Poster Session | Lung Cancer Non-Small Cell Metastatic | Lung Cancer | Immunogenicity and disease control induced by a multineoantigen vaccine (ADXS-503) in patients with metastatic non small cell lung cancer who have progressed on pembrolizumab. | NCT03847519 | Study of ADXS-503 With or Without Pembro in Subjects With Metastatic Non-Small Cell Lung Cancer A Phase 1/2, Open-Label Study of ADXS-503 Alone and in Combination With Pembrolizumab in Subjects With Metastatic Squamous or Non-Squamous Non-Small Cell Lung Cancer | - Lung Cancer, Non-Small Cell - Metastatic Squamous Cell Carcinoma - Metastatic Non-Squamous Cell Carcinoma | - ADXS-503 - Pembrolizumab | Phase 1/Phase 2 | Recruiting | 74 (Anticipated) | None (Open Label) | - Safety/Tolerability of ADXS-503 monotherapy in Part A and ADXS-503 with pembrolizumab in Part B: graded per comment terminology criteria for adverse events (CTCAE) version 4.03 - Preliminary anti-tumor activity of ADXS-503 + pembrolizumab in Part C | - Preliminary anti-tumor activity of ADXS-503 alone in Part A and ADXS-503 with Pembrolizumab in Part B - Progression-free survival (PFS) and PFS rates for subjects treated with ADXS-503 monotherapy in Part A and ADXS-503 + pembrolizumab in Part B and Part C. - Overall survival (OS) and OS rates for subjects treated with ADXS-503 monotherapy in Part A and ADXS-503 with pembrolizumab in Part B and Part C - Safety/Tolerability of ADXS-503 with pembrolizumab in Part C: graded per comment terminology criteria for adverse events (CTCAE) version 4.03 | |||||||||||
27 | 25 | ADXS | Poster Session | Lung Cancer Non-Small Cell Metastatic | Lung Cancer | A phase 2 study of an off-the-shelf, multi-neoantigen vector (ADXS-503) in patients with metastatic non small cell lung cancer either progressing on prior pembrolizumab or in the first-line setting. | NCT03847519 | Study of ADXS-503 With or Without Pembro in Subjects With Metastatic Non-Small Cell Lung Cancer A Phase 1/2, Open-Label Study of ADXS-503 Alone and in Combination With Pembrolizumab in Subjects With Metastatic Squamous or Non-Squamous Non-Small Cell Lung Cancer | - Lung Cancer, Non-Small Cell - Metastatic Squamous Cell Carcinoma - Metastatic Non-Squamous Cell Carcinoma | - ADXS-503 - Pembrolizumab | Phase 1/Phase 2 | Recruiting | 74 (Anticipated) | None (Open Label) | - Safety/Tolerability of ADXS-503 monotherapy in Part A and ADXS-503 with pembrolizumab in Part B: graded per comment terminology criteria for adverse events (CTCAE) version 4.03 - Preliminary anti-tumor activity of ADXS-503 + pembrolizumab in Part C | - Preliminary anti-tumor activity of ADXS-503 alone in Part A and ADXS-503 with Pembrolizumab in Part B - Progression-free survival (PFS) and PFS rates for subjects treated with ADXS-503 monotherapy in Part A and ADXS-503 + pembrolizumab in Part B and Part C. - Overall survival (OS) and OS rates for subjects treated with ADXS-503 monotherapy in Part A and ADXS-503 with pembrolizumab in Part B and Part C - Safety/Tolerability of ADXS-503 with pembrolizumab in Part C: graded per comment terminology criteria for adverse events (CTCAE) version 4.03 | |||||||||||
28 | 26 | AFMD | Poster Session | Developmental Therapeutics Immunotherapy | Developmental Therapeutics Immunotherapy | The combination of CD16A/EGFR innate cell engager, AFM24, with SNK01 autologous natural killer cells in patients with advanced solid tumors. | NCT05099549 | Safety, Tolerability, and Anti-Tumor Activity of AFM24 in Combination With SNK01 in Subjects With Advanced/Metastatic EGFR-Expressing Cancers A Phase 1/2a, Open-Label, Multi-Center Study Evaluating the Safety, Tolerability, and Anti-Tumor Activity of AFM24 in Combination With Ex Vivo Expanded Autologous Natural Killer Cells (SNK01) in Subjects With Advanced/Metastatic EGFR-Expressing Cancers | - Squamous Cell Carcinoma of Head and Neck - Carcinoma, Non-Small-Cell Lung - Colorectal Neoplasms - Advanced Solid Tumor - Refractory Tumor - Metastatic Tumor | - AFM24 - SNK01 | Phase 1/Phase 2 | Recruiting | 121 (Anticipated) | None (Open Label) | - Phase 1/Dose Escalation - Phase 2a/Expansion | - Phase 1/Dose Escalation - Phase 2a/Expansion | |||||||||||
29 | 27 | AFMD | Poster Session | Developmental Therapeutics Immunotherapy | Developmental Therapeutics Immunotherapy | A phase 1/2a open label, multicenter study to assess the safety, tolerability, pharmacokinetics, and efficacy of AFM24 in patients with advanced solid cancers: Study design and rationale. | NCT04259450 | Study to Assess AFM24 in Advanced Solid Cancers A Phase 1/2a Open Label, Multicenter Study to Access the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AFM24 in Patients With Advanced Solid Tumors | - Advanced Solid Tumor | - AFM24 | Phase 1/Phase 2 | Recruiting | 155 (Anticipated) | None (Open Label) | - Phase 1: Incidence of dose limiting toxicities (DLTs) during Cycle 1 - Phase 2a: Overall Response Rate (complete response [CR] + partial response [PR]) | - Pharmacokinetics (PK) of AFM24 - Incidence of patients who develop anti-drug antibodies (ADAs) and neutralizing ADAs during treatment with AFM24 - Overall Response Rate (complete response [CR] + partial response [PR]) - Duration of Response Rate (DOR) - Disease Control rate (CR + PR +stable disease [SD]) - Incidence of patients with treatment-emergent adverse events (TEAEs) and serious adverse events | |||||||||||
30 | 28 | AFMD | Poster Session | Developmental Therapeutics Immunotherapy | Developmental Therapeutics Immunotherapy | AFM24 in combination with atezolizumab in patients with advanced EGFR-expressing solid tumors: Phase 1/2a study design and rationale. | NCT05109442 | Study to Assess AFM24 in Combination With Atezolizumab in Selected Advanced/Metastatic EGFR-expressing Cancers A Phase 1/2a Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AFM24 in Combination With Atezolizumab in Patients With Selected Advanced/Metastatic EGFR-expressing Cancers | - Advanced Solid Tumor | - AFM24 - Atezolizumab 840 MG in 14 ML Injection | Phase 1/Phase 2 | Recruiting | 105 (Anticipated) | None (Open Label) | - Phase 1: Incidence of dose limiting toxicities (DLTs) during Cycle 1 - Phase 2a: Overall Response Rate (complete response [CR] + partial response [PR]) | - Incidence of TEAEs and SAEs - Pharmacokinetics (PK) of AFM24 - Frequency of patients developing anti-drug antibodies (ADAs) against AFM24 - Phase 1: Overall Response Rate (complete response [CR] + partial response [PR]) - Phase 2a: Progression-free survival - Phase 2a: Duration of response - Phase 2a: Clinical benefit rate (CR or PR [any duration] or stable disease equal or > 24 weeks) | |||||||||||
31 | 29 | AKYA | Publication Only | Melanoma/Skin Cancers | Melanoma/Skin Cancers | Whole-slide multispectral imaging reveals the immune subtypes of melanoma associated with the tumor microenvironment: An automated 7-color mIF assay. | |||||||||||||||||||||
32 | 30 | ALKS | Oral Abstract Session | Developmental Therapeutics Immunotherapy | Developmental Therapeutics Immunotherapy | Nemvaleukin alfa monotherapy and in combination with pembrolizumab in patients (pts) with advanced solid tumors: ARTISTRY-1. | NCT02799095 | A Study of the Effects of ALKS 4230 (Nemvaleukin Alfa) on Subjects With Solid Tumors A Phase 1/2 Study of ALKS 4230 Administered Intravenously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors - ARTISTRY-1 | - Advanced Solid Tumors | - ALKS 4230 - ALKS 4230 + pembrolizumab | Phase 1/Phase 2 | Active, not recruiting | 243 (Actual) | None (Open Label) | - Characterization of adverse events (AEs) and dose-limiting toxicities (DLT) in study Part A - Incidence of drug-related AEs in study Part B - Overall response rate (ORR) of ALKS 4230 monotherapy in patients with melanoma or renal cell carcinoma (Part B) and in combination with pembrolizumab in patients with advanced solid tumors (Part C) | - Disease Control Rate - Duration of response in subjects with CR/iCR or PR/iPR - Serum concentrations of ALKS 4230 will be determined at various time points - Serum will be assayed for the presence of anti-ALKS 4230 antibodies - Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry at various time points - Serum concentrations of proinflammatory cytokines will be assessed using a multiplex method at various time points | |||||||||||
33 | 31 | ALKS | Poster Session | Gynecologic Cancer | Gynecologic Cancer | ARTISTRY-7: A phase 3, multicenter study of nemvaleukin alfa in combination with pembrolizumab versus chemotherapy in patients (pts) with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. | NCT05092360 | Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab A Phase 3, Multicenter, Open-Label, Randomized Study of Nemvaleukin Alfa in Combination With Pembrolizumab Versus Investigator's Choice Chemotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer | - Platinum-resistant Ovarian Cancer - Fallopian Tube Cancer - Primary Peritoneal Cancer | - Nemvaleukin and Pembrolizumab Combination - Pembrolizumab - Nemvaleukin - Pegylated Liposomal Doxorubicin (PLD) - Paclitaxel - Topotecan - Gemcitabine | Phase 3 | Recruiting | 376 (Anticipated) | Single | - Progression-free survival (PFS) as assessed by Investigator | - Objective response rate as assessed by Investigator - Overall Survival Rate - Disease Control Rate (DCR) as assessed by Investigator - Duration of Response (DOR) as assessed by Investigator - Time to Response (TTR) as assessed by Investigator - Cancer antigen (CA)-125 response as defined by the Gynecologic Cancer InterGroup (GCIG) - Incidence of treatment-emergent adverse events (TEAEs) | |||||||||||
34 | 32 | ALKS | Poster Session | Developmental Therapeutics Immunotherapy | Developmental Therapeutics Immunotherapy | ARTISTRY-3: Effect of nemvaleukin alfa with a less frequent IV dosing schedule as monotherapy and in combination with pembrolizumab and impact on the tumor microenvironment (TME) in patients (pts) with advanced solid tumors. | NCT04592653 | Less Frequent IV Dosing & Tumor Microenvironment (TME) Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy and in Combination With Pembrolizumab (ARTISTRY-3) Clinical and Immunologic Activity of Nemvaleukin Alfa With Less Frequent IV Dosing Schedule as Monotherapy and in Combination With Pembrolizumab and Impact on Tumor Microenvironment in Solid Tumor Patients - ARTISTRY-3 | - Advanced Solid Tumor | - Nemvaleukin alfa - Pembrolizumab | Phase 1/Phase 2 | Recruiting | 78 (Anticipated) | None (Open Label) | - Changes in density (cell counts per mm2) of immune cell (including total T cells, CD8+ T cells, CD56+ cells and Treg cells) - Changes in ratios (including T/Treg, CD8+/Treg, CD56+/Treg) based on immunohistochemistry (IHC) and/or immunofluorescence (IF) in the TME between pretreatment and on-treatment (Cycle 2 Day 8) paired tumor biopsies - Incidence of dose-limiting toxicity (DLT) | - Proportion of subjects with objective evidence of Complete or Partial Response [(CR)/immune CR (iCR) or (PR) immune PR (iPR)](CR)/immune CR (iCR) - Duration of response in subjects with Complete or Partial Response [(CR)/immune CR (iCR) or (PR) immune PR (iPR)] - Incidence of Adverse Events - Incidence of drug-related Serious Adverse Events - Incidence of drug-related Adverse Events leading to discontinuation - Serum concentrations of ALKS 4230 - Serum will be assayed for the presence of anti-ALKS 4230 antibodies - Changes in absolute cell numbers (including total T cells, CD8+ T cells, NK cells and Treg cells) (See clinicaltrials.gov for the complete list of secondary endpoints.) | |||||||||||
35 | 33 | ALKS | MRK | Poster Session | Melanoma/Skin Cancers | Melanoma/Skin Cancers | ARTISTRY-6: Nemvaleukin alfa monotherapy in patients with advanced mucosal and cutaneous melanoma. | NCT04830124 | Nemvaleukin Alfa (ALKS 4230) Monotherapy in Patients With Advanced Cutaneous Melanoma or Advanced Mucosal Melanoma - ARTISTRY-6 A Phase 2, Open-label, Multicenter, Cohort Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy Administered Subcutaneously in Patients With Advanced Cutaneous Melanoma or Intravenously in Patients With Advanced Mucosal Melanoma Who Have Previously Received Anti-PD-[L]-1 Therapy - ARTISTRY-6 | - Cutaneous Melanoma - Mucosal Melanoma | - Nemvaleukin Alfa Subcutaneous - Nemvaleukin Alfa Intravenous | Phase 2 | Recruiting | 110 (Anticipated) | Single | - Centrally-assessed overall response rate (ORR) | - Centrally-assessed duration of response (DOR) - Centrally-assessed progression free survival (PFS) - Centrally-assessed disease control rate (DCR) - Centrally-assessed time to response (TTR) - Incidence of treatment-emergent adverse events - Investigator-assessed overall response rate (ORR) - Investigator-assessed duration of response (DOR) - Investigator-assessed progression free survival (PFS) (See clinicaltrials.gov for the complete list of secondary endpoints.) | ||||||||||
36 | 34 | ALPMY | SGEN | Poster Discussion Session | Genitourinary Cancer Kidney and Bladder | Genitourinary Cancer Kidney and Bladder | Long-term outcomes in EV-301: 24-month findings from the phase 3 trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma. | NCT03474107 | A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301) An Open-Label, Randomized Phase 3 Study to Evaluate Enfortumab Vedotin vs Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301) | - Ureteral Cancer - Urothelial Cancer - Bladder Cancer | - Enfortumab Vedotin - Docetaxel - Vinflunine - Paclitaxel | Phase 3 | Active, not recruiting | 608 (Actual) | None (Open Label) | - Overall Survival (OS) | - Progression Free Survival on Study Therapy (PFS1) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) - Overall Response Rate (ORR) as Per RECIST V1.1 - Disease Control Rate (DCR) as Per RECIST V1.1 - Duration of Response (DOR) as Per RECIST V1.1 - Change From Baseline to Week 12 in European Organisation for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire Global Health Status (QL2 Score) - Change From Baseline to Week 12 in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS) - Number of Participants With Treatment Emergent Adverse Events - Number of Participants With ECOG Performance Status | ||||||||||
37 | 35 | ALPMY | Poster Session | Gastrointestinal Cancer Gastroesophageal, Pancreatic, and Hepatobiliary | Gastrointestinal Cancer Gastroesophageal, Pancreatic, and Hepatobiliary | Zolbetuximab plus gemcitabine and nab-paclitaxel (GN) in first-line treatment of claudin 18.2-positive metastatic pancreatic cancer (mPC): Phase 2, open-label, randomized study. | NCT03816163 | A Study to Assess the Efficacy and Safety of IMAB362 in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma A Phase 2, Open-Label, Randomized Study to Assess the Efficacy and Safety of Zolbetuximab (IMAB362) in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma | - Pancreatic Cancer - Metastatic Pancreatic Cancer - Metastatic Pancreatic Adenocarcinoma | - zolbetuximab - nab-paclitaxel - gemcitabine | Phase 2 | Recruiting | 369 (Anticipated) | None (Open Label) | - Dose Limiting Toxicities (DLT) - (safety lead in) - Overall Survival (OS) - Safety assessed by Adverse Events (AEs) - Safety assessed by incidence of serious adverse events (SAE) - Safety assessed by incidence of treatment emergent adverse events (TEAE) - Number of participants with laboratory value abnormalities and/or adverse events (AEs) - Number of participants with vital sign abnormalities and /or adverse events (AEs) - Number of participants with electrocardiograms (ECG) abnormalities and or adverse events (See clinicaltrials.gov for the complete list of primary endpoints.) | - Progression Free Survival (PFS) - Objective Response Rate (ORR) - Number of anti-drug antibody (ADA) Positive Participants - Disease Control Rate (DCR) - Duration Of Response (DOR) - Change in CA (Cancer Antigen) 19-9 - PK of zolbetuximab: Concentration Immediately Prior to Dosing (Ctrough) - PK of Nab-P: Area Under the Concentration-time Curve from the Time of Dosing Extrapolated to Time Infinity (AUCinf) (See clinicaltrials.gov for the complete list of secondary endpoints.) | |||||||||||
38 | 36 | ALPMY | PFE | Poster Session | Genitourinary Cancer Prostate, Testicular, and Penile | Genitourinary Cancer Prostate, Testicular, and Penile | The association of germline HSD3B1 genotype with outcomes in metastatic hormone-sensitive prostate cancer (mHSPC) treated with androgen deprivation therapy (ADT) with or without enzalutamide (ENZA) [ARCHES]. | NCT02677896 | A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) A Multinational, Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) | - Metastatic Hormone Sensitive Prostate Cancer | - Enzalutamide - Placebo | Phase 3 | Active, not recruiting | 1150 (Actual) | Quadruple | - Radiographic Progression-Free Survival (rPFS) Based on Independent Central Review (ICR) of Bone Scan According to Prostate Cancer Clinical Trials Working Group 2 (PCWG2) Criteria - rPFS Based on ICR of Bone Scan According to Protocol Assessment Criteria | - Overall Survival (OS) - Time to Prostate Specific Antigen (PSA) Progression - Time to Start of New Antineoplastic Therapy - PSA Undetectable Rate - Objective Response Rate (ORR) - Time to Deterioration in Urinary Symptoms - Time to First Symptomatic Skeletal Event (SSE) - Time to Castration Resistance (See clinicaltrials.gov for the complete list of secondary endpoints.) | ||||||||||
39 | 37 | ALPMY | PFE | Poster Session | Genitourinary Cancer Prostate, Testicular, and Penile | Genitourinary Cancer Prostate, Testicular, and Penile | Prevalence of DNA damage repair (DDR) alterations in patients with metastatic hormone-sensitive prostate cancer (mHSPC) receiving enzalutamide (ENZA) or placebo (PBO) plus androgen deprivation therapy (ADT): ARCHES post hoc analysis. | NCT02677896 | A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) A Multinational, Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) | - Metastatic Hormone Sensitive Prostate Cancer | - Enzalutamide - Placebo | Phase 3 | Active, not recruiting | 1150 (Actual) | Quadruple | - Radiographic Progression-Free Survival (rPFS) Based on Independent Central Review (ICR) of Bone Scan According to Prostate Cancer Clinical Trials Working Group 2 (PCWG2) Criteria - rPFS Based on ICR of Bone Scan According to Protocol Assessment Criteria | - Overall Survival (OS) - Time to Prostate Specific Antigen (PSA) Progression - Time to Start of New Antineoplastic Therapy - PSA Undetectable Rate - Objective Response Rate (ORR) - Time to Deterioration in Urinary Symptoms - Time to First Symptomatic Skeletal Event (SSE) - Time to Castration Resistance (See clinicaltrials.gov for the complete list of secondary endpoints.) | ||||||||||
40 | 38 | ALPMY | Poster Session | Genitourinary Cancer Kidney and Bladder | Genitourinary Cancer Kidney and Bladder | Benchmarking maintenance therapy survival in first-line advanced urothelial carcinoma using disease modeling. | |||||||||||||||||||||
41 | 39 | ALPMY | Publication Only | Health Services Research and Quality Improvement | Health Services Research and Quality Improvement | Patient preferences for treatment and outcomes in hormone-sensitive prostate cancer (HSPC). | |||||||||||||||||||||
42 | 40 | ALPMY | Poster Session | Genitourinary Cancer Kidney and Bladder | Genitourinary Cancer Kidney and Bladder | Study EV-103 Cohort H: Antitumor activity of neoadjuvant treatment with enfortumab vedotin monotherapy in patients with muscle-invasive bladder cancer who are cisplatin-ineligible. | NCT03288545 | A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer A Study of Enfortumab Vedotin (ASG-22CE) as Monotherapy or in Combination With Other Anticancer Therapies for the Treatment of Urothelial Cancer | - Carcinoma, Transitional Cell - Urinary Bladder Neoplasms - Urologic Neoplasms - Renal Pelvis Neoplasms - Urothelial Cancer - Ureteral Neoplasms - Urethral Neoplasms | - enfortumab vedotin (EV) - pembrolizumab - cisplatin - carboplatin - gemcitabine | Phase 1/Phase 2 | Recruiting | 457 (Anticipated) | None (Open Label) | - Type, incidence, severity, seriousness, and relatedness of adverse events (Dose escalation and Expansion Parts 1 to 3 cohorts only) - Type, incidence, and severity of laboratory abnormalities (Dose escalation and Expansion Parts 1 to 3 cohorts only) - Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) (Cohort K only) - Pathological complete response (pCR) rate per central pathology review (MIBC cohorts only) | - Incidence of dose-limiting toxicity (DLT) - Confirmed ORR by investigator assessment according to RECIST 1.1 (la/mUC cohorts only) - Confirmed ORR by BICR according to RECIST 1.1 (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only) - Confirmed ORR by investigator assessment per the modified RECIST 1.1 for immune-based therapeutics (iRECIST) (Dose escalation and Part 1-3 cohorts with pembrolizumab only) - Disease control rate (DCR) by investigator assessment according to RECIST 1.1 (la/mUC cohorts only) - DCR by BICR according to RECIST 1.1 (la/mUC cohorts only) - DCR by investigator assessment according to iRECIST (Dose escalation and Part 1-3 cohorts using pembrolizumab only) - Duration of response (DOR) by investigator assessment according to RECIST 1.1 (la/mUC cohorts only) (See clinicaltrials.gov for the complete list of secondary endpoints.) | |||||||||||
43 | 41 | ALPN | MRK | Poster Session | Developmental Therapeutics Immunotherapy | Developmental Therapeutics Immunotherapy | Davoceticept (ALPN-202), a PD-L1-dependent CD28 costimulator and dual checkpoint inhibitor, in combination with pembrolizumab in patients with advanced malignancies (NEON-2). | NCT04920383 | ALPN-202 With PD-1 Inhibition in Advanced Malignancies An Open-label Study of ALPN-202 Combined With PD-1 Inhibition in Subjects With Advanced Malignancies (NEON-2) | - Advanced Solid Tumor - Lymphoma | - ALPN-202 - Pembrolizumab | Phase 1 | Active, not recruiting | 323 (Anticipated) | None (Open Label) | - Adverse events | - Objective response | ||||||||||
44 | 42 | ALPN | BMY | Poster Session | Developmental Therapeutics Immunotherapy | Developmental Therapeutics Immunotherapy | Dose escalation of davoceticept, a conditional CD28 costimulator and dual checkpoint inhibitor, in advanced malignancies (NEON-1). | NCT04186637 | An Open-label Study of ALPN-202 in Subjects With Advanced Malignancies An Open-label Study of ALPN-202 in Subjects With Advanced Malignancies (NEON-1) | - Advanced Solid Tumor - Lymphoma | - ALPN-202 | Phase 1 | Recruiting | 102 (Anticipated) | None (Open Label) | - Adverse events | - Objective response | ||||||||||
45 | 43 | AMAM | Poster Session | Breast Cancer Metastatic | Breast Cancer | Targeting HER2-positive metastatic breast cancer with ARX788, a novel anti-HER2 antibody-drug conjugate in patients whose disease is resistant or refractory to T-DM1, and/or T-DXd, and/or tucatinib-containing regimens. | NCT04829604 | ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03) A Global, Phase 2 Study of ARX788 in HER2-positive, Metastatic Breast Cancer Patients Whose Disease is Resistant or Refractory to T-DM-1 or T-DXd, and/or Tucatinib-containing Regimens | - HER2 Positive Metastatic Breast Cancer | - ARX788 | Phase 2 | Recruiting | 210 (Anticipated) | None (Open Label) | - Objective response rate (ORR) | - Duration of response (DOR) - Best percent change in the sum of the longest diameters of measurable tumors - Best overall response (BOR) - Disease control rate (DCR) - Progression-free survival (PFS) - Overall survival (OS) - The number of subjects experiencing adverse event TEAEs - Maximum serum concentration (Cmax) for ARX788, total antibody, and pAF-AS269 (See clinicaltrials.gov for the complete list of secondary endpoints.) | |||||||||||
46 | 44 | AMGN | Poster Session | Lung Cancer Non-Small Cell Metastatic | Lung Cancer | Trial in progress: A phase 2 study of sotorasib as first-line treatment in patients with stage IV non small cell lung cancer (NSCLC) whose tumors harbor a KRAS p.G12C mutation (CodeBreaK 201). | NCT04933695 | A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment A Phase 2, Multicenter, Open-label Study of Sotorasib (AMG 510) in Subjects With Stage IV NSCLC Whose Tumors Harbor a KRAS G12C Mutation in Need of First-line Treatment (CodeBreaK 201) | - Non-small Cell Lung Cancer | - Sotorasib | Phase 2 | Recruiting | 170 (Anticipated) | None (Open Label) | - Objective Response Rate (OR) | - Disease Control Rate - Duration of Reponse (DOR) - Time to Response (TTR) - Progression-free Survival (PFS) - Overall Survival (OS) - Number of Participants with a Treatment-emergent Adverse Event (TEAE) - Number of Participants with a Treatment-related Adverse Event - Number of Participants with a Clinically Significant Change from Baseline in Vital Signs (See clinicaltrials.gov for the complete list of secondary endpoints.) | |||||||||||
47 | 45 | AMGN | Publication Only | Gastrointestinal Cancer Colorectal and Anal | Gastrointestinal Cancer Colorectal and Anal | Real-world outcomes among patients with metastatic colorectal cancer treated first line with bevacizumab-awwb. | |||||||||||||||||||||
48 | 46 | AMGN | Poster Session | Gastrointestinal Cancer Colorectal and Anal | Gastrointestinal Cancer Colorectal and Anal | Predictive and prognostic value of carcinoembryonic antigen (CEA) on maintenance therapy with 5-fluoruracil/leucovorin plus panitumumab or 5-fluoruracil/leucovorin alone in RAS wildtype metastatic colorectal cancer: Evaluation of the phase II PanaMa trial (AIO KRK 0212). | NCT01991873 | Maintenance Therapy With 5-FU/FA Plus Panitumumab vs. 5-FU/FA Alone After Prior Induction and Re-induction After Progress for 1st-line Treatment of Metastatic Colorectal Cancer Randomized Phase II Study for Evaluation of Efficacy and Safety of Maintenance Treatment With 5-FU/FA Plus Panitumumab vs. 5-FU/FA Alone After Prior Induction Treatment With mFOLFOX6 Plus Panitumumab and Re-induction With mFOLFOX6 Plus Panitumumab in Case of Progression for First-line Treatment of Patients With Metastatic Colorectal Cancer | - Metastatic Colorectal Cancer | - Maintenance Chemotherapy - Panitumumab (Within maintenance phase) - mFOLFOX6 (Within re-induction phase) - Panitumumab (Within re-induction phase) | Phase 2 | Active, not recruiting | 387 (Actual) | None (Open Label) | - Progression-free survival | - failure of treatment strategy - Progression-free survival of re-induction - Objective response after 12 weeks of induction chemotherapy - Objective best response during maintenance and re-induction - Overall survival - Safety - Health and skin related Quality of life | |||||||||||
49 | 47 | AMGN | Poster Session | Gastrointestinal Cancer Gastroesophageal, Pancreatic, and Hepatobiliary | Gastrointestinal Cancer Gastroesophageal, Pancreatic, and Hepatobiliary | Trial in progress: Phase 1b/3 study of bemarituzumab + mFOLFOX6 + nivolumab versus mFOLFOX6 + nivolumab in previously untreated advanced gastric and gastroesophageal junction (GEJ) cancer with FGFR2b overexpression (FORTITUDE-102). | NCT05111626 | Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression | - Gastric Cancer - Gastroesophageal Junction Adenocarcinoma | - Bemarituzumab - Nivolumab - mFOLFOX6 - Placebo | Phase 1 | Recruiting | 702 (Anticipated) | Double | - Part 1: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) - Part 1: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs) - Part 1: Number of Participants Who Experienced One or More Related TEAEs - Part 1: Number of Participants With Clinically Significant Changes in Vital Signs - Part 1: Number of Participants With Clinically Significant Changes in Visual Acuity - Part 1: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) - Part 1: Number of Participants With Clinically Significant Changes in Physical Examinations - Part 1: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests (See clinicaltrials.gov for the complete list of primary endpoints.) | - Part 1 & 2: Objective Response (OR) - Part 1 & 2: Duration of Response (DoR) - Part 1 & 2: Disease Control Rate (DCR) - Part 1 & 2: Progression Free Survival (PFS) - Part 1: Overall Survival - Part 2: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs) - Part 2: Number of Participants With Clinically Significant Changes in Vital Signs - Part 2: Number of Participants With Clinically Significant Changes in Visual Acuity (See clinicaltrials.gov for the complete list of secondary endpoints.) | |||||||||||
50 | 48 | AMGN | Poster Discussion Session | Hematologic Malignancies Plasma Cell Dyscrasia | Hematologic Malignancies | A phase II study of daratumumab with weekly carfilzomib, pomalidomide, and dexamethasone in relapsed and refractory multiple myeloma. | NCT04176718 | Daratumumab, Carfilzomib, Pomalidomide, Dexamethasone In MM A Phase II Study of Daratumumab With Weekly Carfilzomib, Pomalidomide, and Dexamethasone in Relapsed and Refractory Multiple Myeloma | - Multiple Myeloma - Refractory Multiple Myeloma - Multiple Myeloma in Relapse - Relapse | - Daratumumab - Carfilzomib - Pomalidomide - Dexamethasone | Phase 2 | Recruiting | 43 (Anticipated) | None (Open Label) | - Objective response rate of the daratumumab, carfilzomib, pomalidomide, and dexamethasone combination - Number of dose limiting toxicity grade 4 or higher treatment related | - Progression-free survival (PFS) - Rate of Minimal residual disease (MRD) negative status | |||||||||||
51 | 49 | AMGN | Poster Session | Gastrointestinal Cancer Colorectal and Anal | Gastrointestinal Cancer Colorectal and Anal | Impact of age and gender on the efficacy and safety of panitumumab plus fluorouracil and folinic acid versus fluorouracil and folinic acid alone as maintenance therapy in RAS WT metastatic colorectal cancer (mCRC): Subgroup analysis of the PANAMA-study (AIO-KRK-0212). | NCT01991873 | Maintenance Therapy With 5-FU/FA Plus Panitumumab vs. 5-FU/FA Alone After Prior Induction and Re-induction After Progress for 1st-line Treatment of Metastatic Colorectal Cancer Randomized Phase II Study for Evaluation of Efficacy and Safety of Maintenance Treatment With 5-FU/FA Plus Panitumumab vs. 5-FU/FA Alone After Prior Induction Treatment With mFOLFOX6 Plus Panitumumab and Re-induction With mFOLFOX6 Plus Panitumumab in Case of Progression for First-line Treatment of Patients With Metastatic Colorectal Cancer | - Metastatic Colorectal Cancer | - Maintenance Chemotherapy - Panitumumab (Within maintenance phase) - mFOLFOX6 (Within re-induction phase) - Panitumumab (Within re-induction phase) | Phase 2 | Active, not recruiting | 387 (Actual) | None (Open Label) | - Progression-free survival | - failure of treatment strategy - Progression-free survival of re-induction - Objective response after 12 weeks of induction chemotherapy - Objective best response during maintenance and re-induction - Overall survival - Safety - Health and skin related Quality of life | |||||||||||
52 | 50 | AMGN | Poster Session | Gastrointestinal Cancer Colorectal and Anal | Gastrointestinal Cancer Colorectal and Anal | Resistance mechanisms to anti-EGFR therapy in RAS/RAF wildtype colorectal cancer varies by regimen and line of therapy. | |||||||||||||||||||||
53 | 51 | AMGN | Poster Session | Gastrointestinal Cancer Gastroesophageal, Pancreatic, and Hepatobiliary | Gastrointestinal Cancer Gastroesophageal, Pancreatic, and Hepatobiliary | Trial in progress: Phase 3 study of bemarituzumab + mFOLFOX6 versus placebo + mFOLFOX6 in previously untreated advanced gastric or gastroesophageal junction (GEJ) cancer with FGFR2b overexpression (FORTITUDE-101). | NCT05052801 | Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression | - Gastric Cancer - Gastroesophageal Junction Adenocarcinoma | - Bemarituzumab - mFOLFOX6 - Placebo | Phase 3 | Recruiting | 516 (Anticipated) | Double | - Overall Survival (OS) | - Progression-free Survival (PFS) - Objective Response Rate (ORR) - Number of Participants who Experience a Treatment-emergent Adverse Event (TEAE) - Duration of Response (DOR) - Disease Control Rate - Mean Score in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) - Change from Baseline Score in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) - Stomach Cancer Related Symptom Mean Score as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach (EORTC-QLQ-STO22) (See clinicaltrials.gov for the complete list of secondary endpoints.) | |||||||||||
54 | 52 | AMGN | Publication Only | Lung Cancer Non-Small Cell Metastatic | Lung Cancer | Real-world outcomes in patients with KRAS p.G12C mutant advanced non-small cell lung cancer (aNSCLC) treated with docetaxel in second-line or beyond (2L+). | |||||||||||||||||||||
55 | 53 | AMGN | Poster Session | Lung Cancer Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers | Lung Cancer | Phase 2 study of tarlatamab, a DLL3-targeting, half life extended, bispecific T-cell engager (HLE BiTE) immuno-oncology therapy, in relapsed/refractory small cell lung cancer (SCLC). | NCT05060016 | A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC) (DeLLphi-301) A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of Tarlatamab in Subjects With Relapsed/Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment | - Relapsed/Refractory Small Cell Lung Cancer | - Tarlatamab | Phase 2 | Recruiting | 160 (Anticipated) | None (Open Label) | - Part 1 Only: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator - Part 1 Only: Number of Participants who Experience One or More Treatment-emergent Adverse Events - Part 1 Only: Serum Concentrations of Tarlatamab - Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR) | - Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR) - Disease Control (DC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR) - Duration of Disease Control (DC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR) - Progression-free Survival (PFS) Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR) - Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator - Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator - Disease Control (DC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator - Duration of Disease Control (DC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator (See clinicaltrials.gov for the complete list of secondary endpoints.) | |||||||||||
56 | 54 | AMGN | TAK | Poster Discussion Session | Hematologic Malignancies Leukemia, Myelodysplastic Syndromes, and Allotransplant | Hematologic Malignancies | A phase II trial of a chemotherapy-free combination of ponatinib and blinatumomab in adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). | NCT03263572 | Blinatumomab, Methotrexate, Cytarabine, and Ponatinib in Treating Patients With Philadelphia Chromosome-Positive, or BCR-ABL Positive, or Relapsed/Refractory, Acute Lymphoblastic Leukemia Phase II Study of the Combination of Blinatumomab and Ponatinib in Patients With Philadelphia Chromosome (Ph)-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL) | - Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive - Acute Lymphoblastic Leukemia - BCR-ABL1 Fusion Protein Expression - Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive - Philadelphia Chromosome Positive - Recurrent Acute Lymphoblastic Leukemia - Refractory Acute Lymphoblastic Leukemia - t(9;22) | - Blinatumomab - Cytarabine - Methotrexate - Ponatinib | Phase 2 | Recruiting | 60 (Anticipated) | None (Open Label) | - Complete molecular response (CMR) rate in newly diagnosed Ph-positive and/or BCR-ABL-positive acute lymphoblastic leukemia (ALL) - Overall response rate (ORR) in relapsed/refractory ALL - Relapse-free survival - Event-free survival - Overall survival | |||||||||||
57 | 55 | AMGN | Poster Session | Developmental Therapeutics Molecularly Targeted Agents and Tumor Biology | Developmental Therapeutics Molecularly Targeted Agents and Tumor Biology | Design and rationale of a phase 1 dose-escalation study of AMG 193, a methylthioadenosine (MTA)-cooperative PRMT5 inhibitor, in patients with advanced methylthioadenosine phosphorylase (MTAP)-null solid tumors. | NCT05094336 | AMG 193, Methylthioadenosine (MTA) Cooperative Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor, Alone and in Combination With Docetaxel in Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors A Phase 1/1b/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 193 Alone and in Combination With Docetaxel in Subjects With Advanced MTAP-null Solid Tumors | - Advanced MTAP-null Solid Tumors | - AMG 193 - Docetaxel | Phase 1/Phase 2 | Recruiting | 340 (Anticipated) | None (Open Label) | - Parts 1 and 2: Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) - Parts 1 and 2: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE) - Part 3: Objective Response Rate (ORR) | - Parts 1 and 2: Maximal Plasma Concentration (Cmax) of AMG 193 - Parts 1 and 2: Time to Achieve Maximal Plasma Concentration (Tmax) of AMG 193 - Parts 1 and 2: Area Under the Plasma Concentration Versus Time Curve (AUC) of AMG 193 - Part 2 Only: Maximal Plasma Concentration (Cmax) of Docetaxel - Part 2 Only: Time to Achieve Maximal Plasma Concentration (Tmax) of Docetaxel - Part 2 Only: Area Under the Plasma Concentration Versus Time Curve (AUC) of Docetaxel - Parts 1 and 2: Objective Response Rate (ORR) - Parts 1, 2 and 3: Disease Control Rate (DCR) (See clinicaltrials.gov for the complete list of secondary endpoints.) | |||||||||||
58 | 56 | AMGN | Oral Abstract Session | Breast Cancer Local/Regional/Adjuvant | Breast Cancer | Long-term outcomes of adjuvant denosumab in breast cancer: Fracture reduction and survival results from 3,425 patients in the randomised, double-blind, placebo-controlled ABCSG-18 trial. | NCT00556374 | Study to Determine Treatment Effects of Denosumab in Patients With Breast Cancer Receiving Aromatase Inhibitor Therapy A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Phase 3 Study to Determine the Treatment Effect of Denosumab in Subjects With Non-Metastatic Breast Cancer Receiving Aromatase Inhibitor Therapy. | - Breast Cancer | - Placebo - Denosumab - Non-steroidal aromatase inhibitor therapy - Zoledronic Acid - Standard of Care | Phase 3 | Active, not recruiting | 3420 (Actual) | Quadruple | - Time to First Clinical Fracture | - Percent Change From Baseline in Total Lumbar Spine Bone Mineral Density (BMD) at Month 36 at Pre-selected Sites - Percent Change From Baseline in Total Hip BMD at Month 36 at Pre-selected Sites - Percent Change From Baseline in Femoral Neck BMD at Month 36 at Pre-selected Sites - Number of Participants With New Vertebral Fractures - Number of Participants With New or Worsening Vertebral Fractures - Disease-free Survival - Bone Metastases-free Survival - Overall Survival | |||||||||||
59 | 57 | AMGN | Poster Session | Genitourinary Cancer Prostate, Testicular, and Penile | Genitourinary Cancer Prostate, Testicular, and Penile | A phase 1 study of AMG 509 in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). | NCT04221542 | Study of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer | - Prostate Cancer | - AMG 509 - Abiraterone - Enzalutamide | Phase 1 | Recruiting | 359 (Anticipated) | None (Open Label) | - Incidence of treatment-emergent adverse events - Incidence of treatment-related adverse events - Dose limiting toxicities (DLTs) - Number of participants with changes in vital signs - Number of participants with changes in the electrocardiogram (ECG) records. - Number of participants with changes in the clinical laboratory tests results. | - Maximum serum concentration (Cmax) for AMG 509 - Time to maximum serum concentration (Tmax) for AMG 509 - Minimum serum concentration (Cmin) for AMG 509 - Area under the concentration-time curve (AUC) over the dosing interval for AMG 509 - Accumulation following multiple dosing for AMG 509 - Objective response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with Prostate Cancer Working Group 3 (PCWG3) modifications - Prostate specific antigen (PSA) response - Duration of response (DOR) (radiographic and PSA) (See clinicaltrials.gov for the complete list of secondary endpoints.) | |||||||||||
60 | 58 | AMGN | Publication Only | Gastrointestinal Cancer Colorectal and Anal | Gastrointestinal Cancer Colorectal and Anal | Real-world treatment outcomes from nationwide Onco-colon Turkey registry in RAS wi ld-type patients treated with biologics second-line mCRC. | |||||||||||||||||||||
61 | 59 | AMGN | Publication Only | Symptoms and Survivorship | Symptoms and Survivorship | Bone-targeting agent utilization among lung cancer patients with bone metastasis in Taiwan. | |||||||||||||||||||||
62 | 60 | AMGN | Publication Only | Hematologic Malignancies Leukemia, Myelodysplastic Syndromes, and Allotransplant | Hematologic Malignancies | A phase 1b study of blinatumomab with the anti-programmed cell death (PD)-1 antibody AMG 404 in adults with relapsed/refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL). | NCT04524455 | Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor ALL A Phase 1b Open-label Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Administration of Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (ALL) | - Acute Lymphoblastic Leukemia | - Blinatumomab - AMG 404 - Dexamethasone Premedication | Phase 1 | Recruiting | 27 (Anticipated) | None (Open Label) | - Number of Participants who Experience Dose-Limiting Toxicities (DLTs) - Number of Participants who Experience Treatment-Emergent Adverse Events (TEAEs) - Number of Participants who Experience Serious Treatment-Emergent Adverse Events - Number of Participants who Experience Treatment-Related Treatment-Emergent Adverse Events - Number of Participants who Experience Adverse Events of Special Interest (AESI) | - Rate of Complete Remission (CR) Including Complete Remission with Partial Hematological Recovery (CRh*) - Complete Remission (CR) Rate - Duration of Complete Remission (CR) - Duration of Complete Remission (CR) or Complete Remission with Partial Hematological Recovery (CRh*) - Steady State Concentrations (Css) of Blinatumomab - Maximum Observed Concentration (Cmax) of AMG 404 - Time to Maximum Observed Concentration (Tmax) of AMG 404 - Area Under the Plasma Concentration-Time Curve (AUC) of AMG 404 (See clinicaltrials.gov for the complete list of secondary endpoints.) | |||||||||||
63 | 61 | AMGN | Clinical Science Symposium | ctDNA: Dawn of a New Era | Special Sessions | Largest evaluation of acquired resistance to sotorasib in KRAS p.G12C-mutated non small cell lung cancer (NSCLC) and colorectal cancer (CRC): Plasma biomarker analysis of CodeBreaK100. | NCT03600883 | A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100) A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Sotorasib (AMG 510) Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and Sotorasib (AMG 510) Combination Therapy in Subjects With Advanced NSCLC With KRAS p.G12C Mutation (CodeBreaK 100) | - KRAS p.G12C Mutant Advanced Solid Tumors | - sotorasib - Anti PD-1/L1 - Midazolam | Phase 1/Phase 2 | Recruiting | 793 (Anticipated) | None (Open Label) | - Primary: Number of subjects with treatment-emergent adverse events - Primary: Number of subjects with treatment-related adverse events - Primary: Number of subjects with grade ≥3 treatment-emergent adverse events - Primary: Number of subjects with serious adverse events - Primary: Number of subjects with adverse events of interest - Primary: Number of subjects with clinically significant changes in vital signs - Primary: Number of subjects with clinically significant changes in physical examination results - Primary: Number of subjects with clinically significant changes on electrocardiograms (ECGs) (See clinicaltrials.gov for the complete list of primary endpoints.) | - Secondary: Plasma concentration (Cmax) of sotorasib - Secondary: Plasma concentration (Cmax) of midazolam - Secondary: Time to achieve Cmax (Tmax) of sotorasib - Secondary: Area under the plasma concentration-time curve (AUC) of sotorasib - Secondary: Area under the plasma concentration-time curve (AUC) of midazolam - Secondary: Clearance of midazolam from the plasma - Secondary: Terminal half-life (t1/2) of midazolam - Secondary: Objective response rate (ORR) as assessed by RECIST 1.1 criteria (See clinicaltrials.gov for the complete list of secondary endpoints.) | |||||||||||
64 | 62 | AMGN | Poster Session | Melanoma/Skin Cancers | Melanoma/Skin Cancers | Neo-adjuvant T-VEC plus nivolumab combination therapy for resectable early-stage or metastatic (IIIB-IVM1a) melanoma with injectable disease: The NIVEC trial. | NCT04330430 | Neo-adjuvant T-VEC + Nivolumab Combination Therapy for Resectable Early Metastatic (Stage IIIB/C/D-IV M1a) Melanoma With Injectable Disease Neo-adjuvant T-VEC + Nivolumab Combination Therapy for Resectable Early Metastatic (Stage IIIB/C/D-IV M1a) Melanoma With Injectable Disease | - Melanoma Stage III - Melanoma Stage IV | - T-VEC | Phase 2 | Recruiting | 24 (Anticipated) | None (Open Label) | - Pathologic response | - Rate of delay of surgery > 14 days - Rate of failure to perform surgery defined as no surgery at all (due to progressive disease or adverse events) - Relapse free survival (RFS) - Safety of neo-adjuvant combination of T-VEC and nivolumab according to CTCAE v5.0 - Acquiring tumor tissue | |||||||||||
65 | 63 | ANIX | Poster Session | Breast Cancer Metastatic | Breast Cancer | Phase I trial of an alpha-lactalbumin vaccine in patients with moderate- to high-risk operable triple-negative breast cancer (TNBC). | NCT04674306 | Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer Phase I Trial of Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Patients With Non-Metastatic Triple-Negative Breast Cancer at High Risk of Recurrence | - Pathologic Stage IIA-IIIC Triple-Negative Breast Cancer - TNBC - Triple-Negative Breast Cancer - Residual Disease | - α-lactalbumin vaccine - Zymosan | Early Phase 1 | Recruiting | 30 (Anticipated) | None (Open Label) | - MTD of α-lactalbumin vaccine | - Lowest Immunologic Dose (LID) of α-lactalbumin vaccine | |||||||||||
66 | 64 | ARAV | Poster Session | Genitourinary Cancer Kidney and Bladder | Genitourinary Cancer Kidney and Bladder | Phase Ib study of avelumab and novel AXL inhibitor avb-S6-500 in patients with metastatic urothelial carcinoma (mUC). | NCT04004442 | Avelumab in Combination With AVB-S6-500 in Patients With Advanced Urothelial Carcinoma Phase I Study of Avelumab in Combination With AXL Inhibitor AVB-S6-500 in Patients With Advanced Urothelial Carcinoma | - Urothelial Carcinoma | - Avelumab - AVB-S6-500 | Phase 1 | Active, not recruiting | 19 (Actual) | None (Open Label) | - Safety and Tolerability | - Progression Free Survival - Clinical Benefit Rate - Duration of Response - Overall Survival - Investigator assessed Objective Response Rate | |||||||||||
67 | 65 | ARAV | Poster Session | Genitourinary Cancer Kidney and Bladder | Genitourinary Cancer Kidney and Bladder | A phase 1b/2 study of batiraxcept (AVB-S6-500) in combination with cabozantinib, cabozantinib and nivolumab, and as monotherapy in patients with advanced or metastatic clear cell renal cell carcinoma (NCT04300140). | NCT04300140 | Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced or Metastatic Clear Cell Renal Cell Carcinoma A Phase 1b/2 Study Of AVB-S6-500 In Combination With Cabozantinib, AVB-S6-500 In Combination With Cabozantinib and Nivolumab, and AVB-S6-500 Monotherapy in Patients With Advanced or Metastatic Clear Cell Renal Cell Carcinoma | - Clear Cell Renal Cell Carcinoma | - Batiraxcept - Cabozantinib (Cabo) - Nivolumab | Phase 1/Phase 2 | Recruiting | 80 (Anticipated) | None (Open Label) | - Incidence of adverse events in Phase 1b as graded by NCI-CTCAE version 5.0 - Identify the recommended Phase 2 dose of AVB-S6-500 in combination with cabozantinib - Anti-tumor activity of AVB-S6-500 in combination with cabozantinib (ORR) - Anti-tumor activity of AVB-S6-500 in combination with cabozantinib and nivolumab (ORR) - Anti-tumor activity of AVB-S6-500 alone (ORR) - Anti-tumor activity of AVB-S6-500 alone (DOR) - Anti-tumor activity of AVB-S6-500 alone (CBR) - Anti-tumor activity of AVB-S6-500 alone (PFS) (See clinicaltrials.gov for the complete list of primary endpoints.) | - Pharmacokinetics: AUC - Pharmacokinetics: Cmax - Pharmacokinetics: Tmax - Pharmacokinetics: t1/2 - Pharmacodynamic marker assessment - Anti-drug antibody (ADA) titers - Anti-tumor activity of AVB-S6-500 in combination with cabozantinib (CBR) - Anti-tumor activity of AVB-S6-500 in combination with cabozantinib (DOR) (See clinicaltrials.gov for the complete list of secondary endpoints.) | |||||||||||
68 | 66 | ARAV | Poster Discussion Session | Genitourinary Cancer Kidney and Bladder | Genitourinary Cancer Kidney and Bladder | A phase 1b/2 study of batiraxcept (AVB-S6-500) in combination with cabozantinib in patients with advanced or metastatic clear cell renal cell (ccRCC) carcinoma who have received front-line treatment (NCT04300140). | NCT04300140 | Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced or Metastatic Clear Cell Renal Cell Carcinoma A Phase 1b/2 Study Of AVB-S6-500 In Combination With Cabozantinib, AVB-S6-500 In Combination With Cabozantinib and Nivolumab, and AVB-S6-500 Monotherapy in Patients With Advanced or Metastatic Clear Cell Renal Cell Carcinoma | - Clear Cell Renal Cell Carcinoma | - Batiraxcept - Cabozantinib (Cabo) - Nivolumab | Phase 1/Phase 2 | Recruiting | 80 (Anticipated) | None (Open Label) | - Incidence of adverse events in Phase 1b as graded by NCI-CTCAE version 5.0 - Identify the recommended Phase 2 dose of AVB-S6-500 in combination with cabozantinib - Anti-tumor activity of AVB-S6-500 in combination with cabozantinib (ORR) - Anti-tumor activity of AVB-S6-500 in combination with cabozantinib and nivolumab (ORR) - Anti-tumor activity of AVB-S6-500 alone (ORR) - Anti-tumor activity of AVB-S6-500 alone (DOR) - Anti-tumor activity of AVB-S6-500 alone (CBR) - Anti-tumor activity of AVB-S6-500 alone (PFS) (See clinicaltrials.gov for the complete list of primary endpoints.) | - Pharmacokinetics: AUC - Pharmacokinetics: Cmax - Pharmacokinetics: Tmax - Pharmacokinetics: t1/2 - Pharmacodynamic marker assessment - Anti-drug antibody (ADA) titers - Anti-tumor activity of AVB-S6-500 in combination with cabozantinib (CBR) - Anti-tumor activity of AVB-S6-500 in combination with cabozantinib (DOR) (See clinicaltrials.gov for the complete list of secondary endpoints.) | |||||||||||
69 | 67 | ARVN | Poster Session | Breast Cancer Metastatic | Breast Cancer | ARV-471, an estrogen receptor (ER) PROTAC degrader, combined with palbociclib in advanced ER+/human epidermal growth factor receptor 2 negative (HER2-) breast cancer: Phase 1b cohort (part C) of a phase 1/2 study. | NCT04072952 | A Phase 1/2 Trial of ARV-471 Alone and in Combination With Palbociclib (IBRANCE®) in Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer A Phase 1/2, Open Label, Dose Escalation, and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ARV-471 Alone and in Combination With Palbociclib (IBRANCE®) in Patients With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Locally Advanced or Metastatic Breast Cancer, Who Have Received Prior Hormonal Therapy and Chemotherapy in the Locally Advanced/Metastatic Setting | - Breast Cancer | - ARV-471 - ARV-471 in combination with palbociclib (IBRANCE®) | Phase 1/Phase 2 | Recruiting | 170 (Anticipated) | None (Open Label) | - Part A: Incidence of Dose Limiting Toxicities of ARV-471 - Part A: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-471 - Part A: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-471 - Part B: Assessment of anti-tumor activity of ARV-471 - Part C: Incidence of Dose Limiting Toxicities of combination ARV-471 + palbociclib - Part C: Number of Patients with Adverse Events as a measure of safety and tolerability of combination ARV-471 + palbociclib - Part C: Incidence of laboratory abnormalities as a measure of safety and tolerability of combination ARV-471 + palbociclib | - Part A: Assessment of pharmacokinetic parameter area under the concentration-time curve (AUC). - Part A: Assessment of pharmacokinetic parameter maximum concentration (Cmax). - Part A: Assessment of pharmacokinetic parameter minimum concentration (Cmin). - Part A: Assessment of pharmacokinetic parameter time to maximum concentration (Tmax). - Part A: Assessment of anti-tumor activity of ARV-471 - Part B: Assessment of anti-tumor activity of ARV-471 - Part B: Evaluation of Safety and Tolerability - Part C:Assessment of pharmacokinetic parameter area under the concentration-time curve (AUC) (See clinicaltrials.gov for the complete list of secondary endpoints.) | |||||||||||
70 | 68 | ARVN | Poster Session | Genitourinary Cancer Prostate, Testicular, and Penile | Genitourinary Cancer Prostate, Testicular, and Penile | Phase 1b study of bavdegalutamide, an androgen receptor PROTAC degrader, combined with abiraterone in patients with metastatic prostate cancer. | NCT05177042 | Trial of ARV-110 and Abiraterone in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) A Phase 1b Open-Label, Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ARV-110 in Combination With Abiraterone in Patients With Metastatic Prostate Cancer | - Prostate Cancer Metastatic | - ARV-110 in Combination with Abiraterone | Phase 1 | Recruiting | 40 (Anticipated) | None (Open Label) | - Incidence of dose limiting toxicities of ARV-110 in combination with abiraterone - Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-110 in combination with abiraterone - Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-110 in combination with abiraterone - Recommended Phase 2 dose (RP2D)/schedule for the combination | ||||||||||||
71 | 69 | ASND | Poster Session | Developmental Therapeutics Immunotherapy | Developmental Therapeutics Immunotherapy | IL believe: A phase 1/2, open-label, dose escalation and dose expansion study of TransCon IL-2 / alone or in combination with pembrolizumab or standard-of-care chemotherapy in patients with locally advanced or metastatic solid tumors. | NCT05081609 | IL Believe: A Study of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab or Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors Phase 1/2, Open-label, Dose Escalation and Dose Expansion of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab or Standard of Care Chemotherapy in Participants Aged 18 Years or Older With Locally Advanced or Metastatic Solid Tumor Malignancies | - Advanced Solid Tumor - Locally Advanced Solid Tumor - Metastatic Solid Tumor | - TransCon IL-2 β/γ - Pembrolizumab - Chemotherapy drug | Phase 1/Phase 2 | Recruiting | 86 (Anticipated) | None (Open Label) | - Safety and Tolerability - Maximum Tolerated Dose (MTD) - Recommended Phase 2 Dose (RP2D) | - Overall Response Rate - Duration of Response - Time to Response - Progression Free Survival (PFS) - Overall Survival (OS) - PK Characterization (Cmax) - PK Characterization (Tmax) - PK Characterization (AUClast) (See clinicaltrials.gov for the complete list of secondary endpoints.) | |||||||||||
72 | 70 | ASND | Poster Session | Developmental Therapeutics Immunotherapy | Developmental Therapeutics Immunotherapy | TransCon IL-2 / , a novel long-acting prodrug with sustained release of an IL-2R / -selective IL-2 analog, demonstrates improved pharmacokinetics and profound expansion of cytotoxic immune cells in non-human primates. | |||||||||||||||||||||
73 | 71 | ATNX | Oral Abstract Session | Sarcoma | Sarcoma | Phase I clinical trial to assess safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of NY-ESO-1 specific TCR T-cells (TAEST16001) in HLA-A*02:01 patients with advanced soft tissue sarcoma. | NCT04318964 | TAEST16001 in the Treatment of Soft Tissue Sarcoma An Open, Single Arm and Early Clinical Study of TAEST16001 in the Treatment of Solid Tumor Mainly Containing Soft Tissue Sarcoma With Positive Expression of Tumor Antigen NY-ESO-1 (HLA-A * 02:01) | - Soft Tissue Sarcoma | - TAEST16001 cells | Phase 1 | Recruiting | 12 (Anticipated) | None (Open Label) | - Maximum tolerable dose (MTD） - Dose limited toxicity (DLT) | - Peripheral blood TAEST16001 cell peak (C Max) - Peripheral blood TAEST16001 cell peak time (T Max) - Peripheral blood TAEST16001 cell AUC 0-28 - T cell subsets - Peripheral blood antigen-specific CTL - Effector cell activity | |||||||||||
74 | 72 | ATNX | Poster Session | Breast Cancer Metastatic | Breast Cancer | A novel oral paclitaxel and HM10381 (oraxel)-treated metastatic breast cancer: A phase I study (KX ORAX CN-007). | NCT04993040 | A PK Study of Oraxol in Breast Cancer Patients A Clinical Study to Determine the Pharmacokinetics of Oraxol in Breast Cancer Patients | - Breastcancer | - Oraxol | Phase 1 | Completed | 24 (Actual) | None (Open Label) | - Cmax - Cmin - Cavg - AUC0-t - AUC | - Safety - Tumor response rate - Progression-free survival - Overall survival | |||||||||||
75 | 73 | ATRA | Poster Session | Hematologic Malignancies Lymphoma and Chronic Lymphocytic Leukemia | Hematologic Malignancies | Demographics and treatment outcomes in patients with EBV+ PTLD treated with off-the-shelf EBV-specific CTL under an ongoing expanded access program in Europe: First analyses. | |||||||||||||||||||||
76 | 74 | AVEO | Poster Session | Genitourinary Cancer Kidney and Bladder | Genitourinary Cancer Kidney and Bladder | TiNivo-2: A phase 3, randomized, controlled, multicenter, open-label study to compare tivozanib in combination with nivolumab to tivozanib monotherapy in subjects with renal cell carcinoma who have progressed following one or two lines of therapy where one line has an immune checkpoint inhibitor. | NCT04987203 | Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma TiNivo-2: A Phase 3, Randomized, Controlled, Multicenter, Open-label Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma Who Have Progressed Following One or Two Lines of Therapy Where One Line Has an Immune Checkpoint Inhibitor | - Renal Cell Carcinoma | - Tivozanib - Nivolumab | Phase 3 | Recruiting | 326 (Anticipated) | None (Open Label) | - Progression free survival | - Overall Survival - Objective Response Rate - Duration of Response - Number of subjects with serious and non-serious adverse events | |||||||||||
77 | 75 | AVEO | Poster Session | Genitourinary Cancer Kidney and Bladder | Genitourinary Cancer Kidney and Bladder | Activity of tivozanib in non-clear cell renal cell carcinoma (nccRCC): Subgroup analysis from a phase 2 randomized discontinuation trial. | NCT00502307 | A Study of Tivozanib (AV-951), an Oral VEGF Receptor Tyrosine Kinase Inhibitor, in the Treatment of Renal Cell Carcinoma A Phase 2, Placebo-Controlled, Randomized, Discontinuation Trial of Tivozanib (AV-951) in Patients With Renal Cell Carcinoma | - Carcinoma, Renal Cell | - Tivozanib (AV-951) - Placebo comparator | Phase 2 | Completed | 272 (Actual) | Triple | - Number of Subjects With Adverse Events (AEs)/Serious AEs (SAEs) - Objective Response [Complete Response (CR) + Partial Response (PR)] Rate at 16 Week Open-Label Period (All Treated Population) - Percentage of Randomly Assigned Subjects Remaining Progression Free at 12 Weeks Following Random Assignment to Tivozanib (AV-951) or Placebo | - Number of Subjects With Progression Free-survival (PFS) After Random Assignment (Randomized Sub-set Only) (at 12 Weeks Post Randomization ) - Overall Progression-free Survival (From Start of Treatment) - Time to Peak Plasma Concentration (Tmax) of Tivozanib in a Subset of Subjects - Maximum Observed Serum Concentration During a Dosing Interval at Steady State (Cmax) - Area Under the Serum Concentration Versus Time Curve From Zero to the Last Quantifiable Sampling Point [AUC(0→24)] | |||||||||||
78 | 76 | AVEO | Poster Session | Genitourinary Cancer Kidney and Bladder | Genitourinary Cancer Kidney and Bladder | Maturation of overall survival (OS) in TIVO-3 with long-term follow-up. | NCT02627963 | A Study to Compare Tivozanib Hydrochloride to Sorafenib in Subjects With Refractory Advanced RCC A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib Hydrochloride to Sorafenib in Subjects With Refractory Advanced Renal Cell Carcinoma | - Carcinoma, Renal Cell | - tivozanib hydrochloride - Sorafenib | Phase 3 | Completed | 350 (Actual) | None (Open Label) | - Progression-free Survival (PFS) | - Overall Survival (OS) - Objective Response Rate (ORR) - Duration of Response (DOR) | |||||||||||
79 | 77 | AYLA | Poster Session | Head and Neck Cancer | Head and Neck Cancer | Results of ACCURACY: A phase 2 trial of AL101, a selective gamma secretase inhibitor, in subjects with recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC) harboring Notch activating mutations (Notchmut). | NCT03691207 | A Study Of AL101 In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations A Phase 2, Open-Label, Multi-center Study of AL101 in Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations | - Adenoid Cystic Carcinoma | - AL101 | Phase 2 | Active, not recruiting | 87 (Anticipated) | None (Open Label) | - Objective response rate (ORR; complete response [CR] and partial response [PR]) by RECIST v1.1 | - Frequency, duration and severity of adverse events (AEs) and serious adverse events (SAEs); | |||||||||||
80 | 78 | AZN | Publication Only | Developmental Therapeutics Immunotherapy | Developmental Therapeutics Immunotherapy | Biodegradable nanoparticles inhibit tumor growth by altering tumor-associated macrophages and cancer-associated fibroblasts. | |||||||||||||||||||||
81 | 79 | AZN | Poster Session | Genitourinary Cancer Kidney and Bladder | Genitourinary Cancer Kidney and Bladder | Prognostic impact of bone metastasis in patients with metastatic urothelial carcinoma (mUC) treated with durvalumab (D) with or without tremelimumab (T) in the DANUBE study. | NCT02516241 | Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination With Tremelimumab Versus Standard of Care Chemotherapy in Patients With Unresectable Stage IV Urothelial Cancer | - Urothelial Cancer | - MEDI4736 (Durvalumab) - Tremelimumab - Cisplatin - Carboplatin - Gemcitabine | Phase 3 | Active, not recruiting | 1126 (Actual) | None (Open Label) | - To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Set - To Assess the Efficacy of Durvalumab Monotherapy Versus SoC in Terms of OS in PD-L1-High Analysis Set | - OS, Full Analysis Set - Durvalumab Monotherapy vs SoC - OS, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC - OS, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy - Alive at 24 Months (OS24), Full Analysis Set - Alive at 24 Months (OS24), PD-L1-High Analysis Set - Alive at 24 Months (OS24), PD-L1-Low/Negative Analysis Set - PFS, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC - PFS, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC (See clinicaltrials.gov for the complete list of secondary endpoints.) | |||||||||||
82 | 80 | AZN | Poster Session | Lung Cancer Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers | Lung Cancer | Adverse events self-reported by patients (pts) with extensive-stage small cell lung cancer (ES-SCLC) treated with durvalumab (D) plus platinum-etoposide (EP) or EP in the CASPIAN study. | NCT03043872 | Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN) A Phase III, Randomized, Multicenter,Open-Label, Comparative Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for the First-Line Treatment in Patients With Extensive Disease Small-Cell Lung Cancer (SCLC) (CASPIAN) | - Small Cell Lung Carcinoma Extensive Disease | - Durvalumab - Tremelimumab - Carboplatin - Cisplatin - Etoposide | Phase 3 | Active, not recruiting | 978 (Actual) | None (Open Label) | - Overall Survival (OS) in the Global Cohort; Assessed at Global Cohort Interim Analysis; D + EP Compared With EP - OS in the Global Cohort; Assessed at Global Cohort Final Analysis; D + EP Compared With EP and D + T + EP Compared With EP - OS in the China Cohort; Assessed at China Cohort First Analysis; D + EP Compared With EP - OS in the China Cohort; Assessed at China Cohort Second Analysis; D + EP Compared With EP and D + T + EP Compared With EP | - OS in the Global Cohort; D + T + EP Compared With D + EP - Progression-Free Survival (PFS) in the Global Cohort - Objective Response Rate (ORR) in the Global Cohort - Percentage of Patients Alive and Progression Free at 6 Months (APF6) in the Global Cohort - Percentage of Patients Alive and Progression Free at 12 Months (APF12) in the Global Cohort - Percentage of Patients Alive at 18 Months (OS18) in the Global Cohort - Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations in the Global Cohort - PK of Tremelimumab; Peak and Trough Serum Concentrations in the Global Cohort (See clinicaltrials.gov for the complete list of secondary endpoints.) | |||||||||||
83 | 81 | AZN | Poster Session | Developmental Therapeutics Molecularly Targeted Agents and Tumor Biology | Developmental Therapeutics Molecularly Targeted Agents and Tumor Biology | First-in-human study of the B7-H4 antibody-drug conjugate (ADC) AZD8205 in patients with advanced/metastatic solid tumors. | NCT05123482 | First in Human Study to Evaluate AZD8205 in Patients With Advanced or Metastatic Solid Malignancies A Phase I/IIa Multi-center, Open-label Master Protocol to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of AZD8205 in Participants With Advanced or Metastatic Solid Malignancies | - Breast Cancer - Cholangiocarcinoma - Ovarian Cancer - Endometrial Cancer | - AZD8205 | Phase 1/Phase 2 | Recruiting | 198 (Anticipated) | None (Open Label) | - The number of patients with adverse events - The number of patients with serious adverse events - The number of patients with dose-limiting toxicity (DLT), as defined in the protocol. - The number of patients with changes from baseline laboratory findings, ECGs and vital signs | - Objective Response Rate (ORR) - Duration of response (DoR) - Progression free Survival (PFS) - Disease Control Rate at 12 weeks (DCR-12) - Overall Survival (OS) - Pharmacokinetics of AZD8205: Area Under the concentration-time curve (AUC) - Pharmacokinetics of AZD8205: Maximum plasma concentration of the study drug (Cmax) - Pharmacokinetics of AZD8205: Time to maximum plasma concentration of the study drug (T-max) (See clinicaltrials.gov for the complete list of secondary endpoints.) | |||||||||||
84 | 82 | AZN | Publication Only | Gynecologic Cancer | Gynecologic Cancer | Cost-effectiveness of Olaparib plus Bevacizumab versus Bevacizumab in the maintenance of patients with HRD+ advanced ovarian cancer after response to first-line platinum-based chemotherapy in Spain. | |||||||||||||||||||||
85 | 83 | AZN | Publication Only | Genitourinary Cancer Kidney and Bladder | Genitourinary Cancer Kidney and Bladder | Real-world, population-based study of treatments, survival and healthcare use in advanced urothelial carcinoma of the bladder. | |||||||||||||||||||||
86 | 84 | AZN | Poster Session | Gynecologic Cancer | Gynecologic Cancer | OReO/ENGOT Ov-38 trial: Impact of maintenance olaparib rechallenge according to ovarian cancer patient prognosis An exploratory joint analysis of the BRCA and non-BRCA cohorts. | NCT03106987 | A Study to Examine Olaparib Maintenance Retreatment in Patients With Epithelial Ovarian Cancer. A Phase IIIb, Randomised, Double-blind, Placebo-controlled, Multicentre Study of Olaparib Maintenance Retreatment in Patients With Epithelial Ovarian Cancer Previously Treated With a PARPi and Responding to Repeat Platinum Chemotherapy | - Epithelial Ovarian Cancer | - Active Comparator: Olaparib tablets - Placebo | Phase 3 | Completed | 220 (Actual) | Double | - Efficacy: Progression-free Survival (PFS) | - Efficacy: Overall Survival (OS) - Efficacy: Time to Progression by Gynecologic Cancer Intergroup (GCIG) Criteria - Efficacy: Time to First Subsequent Treatment Commencement (TFST) - Efficacy: Time to Second Subsequent Treatment Commencement (TSST) - Efficacy: Time to Study Treatment Discontinuation (TDT) - Efficacy: Change From Baseline in Health-related Quality of Life (HRQoL) - Number of Patients With Adverse Events (AEs), and Serious Adverse Events (SAEs) - Number of Patients With Adverse Event of Special Interest (AESI). | |||||||||||
87 | 85 | AZN | Poster Session | Lung Cancer Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers | Lung Cancer | Durvalumab treatment initiation delays in patients with unresectable stage III non small cell lung cancer treated at Veterans Health Administration facilities. | |||||||||||||||||||||
88 | 86 | AZN | Poster Session | Gynecologic Cancer | Gynecologic Cancer | Real-world use, tolerability, and dose modifications of PARP inhibitors in ovarian cancer. | |||||||||||||||||||||
89 | 87 | AZN | Clinical Science Symposium | ctDNA: Dawn of a New Era | Special Sessions | Circulating tumor DNA (ctDNA) and late recurrence in high-risk, hormone receptor positive, HER2-negative breast cancer (CHiRP). | |||||||||||||||||||||
90 | 88 | AZN | Poster Session | Gynecologic Cancer | Gynecologic Cancer | Phase Ib INEOV neoadjuvant trial of durvalumab +/- tremelimumab with platinum chemotherapy for patients (pts) with unresectable ovarian cancer (OC): Final complete resection and pathological response rates. | NCT03249142 | Immunotherapy With Neo-adjuvant Chemotherapy for OVarian Cancer A Multicentre Feasibility Randomized Study of Anti-PD-L1 Durvalumab (MEDI4736) With or Without Anti-CTLA-4 Tremelimumab in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Adenocarcinoma, Treated With a First-line Neo-adjuvant Strategy | - Ovarian Cancer | - ARM A Durvalumab/chemotherapy association - ARM B Durvalumab/Tremelimumab/chemotherapy association | Phase 1/Phase 2 | Active, not recruiting | 69 (Actual) | None (Open Label) | - Toxicity after neo-adjuvant treatment | - Toxicity after adjuvant treatment - Toxicity after maintenance therapy - Safety after interval debulking surgery - Progression Free Survival (PFS) based on investigator assessment using the RECIST version 1.1 - Sugarbaker Peritoneal Index Score (PCI) - Time to start of first subsequent therapy or death - overall survival | |||||||||||
91 | 89 | AZN | Poster Discussion Session | Gastrointestinal Cancer Colorectal and Anal | Gastrointestinal Cancer Colorectal and Anal | A phase II study of capecitabine plus concomitant radiation therapy followed by durvalumab (MEDI4736) as preoperative treatment in rectal cancer: PANDORA study final results. | NCT04083365 | Capecitabine Plus Concomitant Radiation Therapy Followed by Durvalumab as Preoperative Treatment in Rectal Cancer A Phase II Study of Capecitabine Plus Concomitant Radiotion Therapy Followed by Durvalumab (MEDI4736) as Preoperative Treatment in Rectal Cancer. | - RECTAL CANCER | - Capecitabine - Radiotherapy - Durvalumab | Phase 2 | Recruiting | 60 (Anticipated) | None (Open Label) | - Pathological complete response (pCR) rate after durvalumab treatment | - The clinical complete remission rate (cCR) after durvalumab treatment - Disease-free survival (DSF) | |||||||||||
92 | 90 | AZN | Poster Session | Gastrointestinal Cancer Colorectal and Anal | Gastrointestinal Cancer Colorectal and Anal | Impact of consensus molecular subtyping (CMS) on survival in the CO.26 trial of durvalumab plus tremelimumab versus best supportive care (BSC) in metastatic colorectal cancer (mCRC). | NCT02870920 | Durvalumab and Tremelimumab and Best Supportive Care vs Best Supportive Care in Patients With Advanced Colorectal Cancer A Phase II Randomized Study of Durvalumab and Tremelimumab and Best Supportive Care vs Best Supportive Care Alone in Patients With Advanced Colorectal Adenocarcinoma Refractory to Standard Therapies | - Colorectal Cancer | - Tremelimumab - Durvalumab - Best Supportive Care | Phase 2 | Active, not recruiting | 180 (Actual) | None (Open Label) | - Overall Survival | - Progression-free Survival - Objective Response Rate | |||||||||||
93 | 91 | AZN | NTRA | Poster Session | Breast Cancer Local/Regional/Adjuvant | Breast Cancer | Serial postoperative ctDNA monitoring of breast cancer recurrence. | ||||||||||||||||||||
94 | 92 | AZN | Poster Session | Gastrointestinal Cancer Colorectal and Anal | Gastrointestinal Cancer Colorectal and Anal | Bcl-xL and association with apoptosis following KRASG12C inhibition in KRASG12C mutant colorectal cancer. | |||||||||||||||||||||
95 | 93 | AZN | Poster Session | Developmental Therapeutics Molecularly Targeted Agents and Tumor Biology | Developmental Therapeutics Molecularly Targeted Agents and Tumor Biology | Rationale and design of phase 1 FTIH study of FOXP3 antisense oligonucleotide AZD8701 in patients with selected advanced solid tumors. | NCT04504669 | First Time in Human Study of AZD8701 With or Without Durvalumab in Participants With Advanced Solid Tumours A Phase I First-in-Human Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AZD8701 Administered Intravenously as Monotherapy and in Combination With Durvaluamb (MEDI4736) in Participants With Advanced Solid Tumours | - Clear Cell Renal Cell Cancer - Non-Small-Cell Lung Cancer - Triple Negative Breast Neoplasms - Squamous Cell Cancer of Head and Neck - Small Cell Lung Cancer - Gastroesophageal Cancer - Melanoma - Cervical Cancer - Advanced Solid Tumours | - AZD8701 - Durvalumab | Phase 1 | Recruiting | 153 (Anticipated) | None (Open Label) | - Maximum Tolerated dose (or optimal dose or maximum feasible dose) and RP2D of AZD8701 as monotherapy and in combination with Durvalumab assessed through evaluation of AEs and SAEs - Maximum Tolerated dose (or optimal dose or maximum feasible dose) and RP2D of AZD8701 as monotherapy and in combination with Durvalumab assessed through evaluation of Dose Limiting Toxicities (DLTs) - Maximum Tolerated dose (or optimal dose or maximum feasible dose) and RP2D of AZD8701 as monotherapy and in combination with Durvalumab assessed through evaluation of vital signs and abnormal laboratory parameters - Incidence of AEs and SAEs related to AZD8701 as monotherapy and in combination with Durvalumab in disease specific expansions treated at the MTD/OBD/MFD - Objective Response Rate according to RECIST 1.1 by investigator assessment in disease specific expansions treated at the MTD/OB/MFD | - Progression-free survival according to RECIST 1.1 by investigator assessment - Duration of Response according to RECIST 1.1 by investigator assessment - Disease Control Rate at 16 weeks according to RECIST 1.1 by investigator assessment - Time to Response according to RECIST 1.1 by investigator assessment - Best percentage change in tumour size according to RECIST 1.1 by investigator assessment - Overall Survival at 18 months - Maximum concentration (Cmax) of AZD8701 in plasma when administered as monotherapy and in combination with Durvalumab - Time to maximum concentration (tmax) of AZD8701 in plasma when administered as monotherapy and in combination with Durvalumab (See clinicaltrials.gov for the complete list of secondary endpoints.) | |||||||||||
96 | 94 | AZN | Poster Discussion Session | Genitourinary Cancer Prostate, Testicular, and Penile | Genitourinary Cancer Prostate, Testicular, and Penile | BRCAAWAY: A randomized phase 2 trial of abiraterone, olaparib, or abiraterone + olaparib in patients with metastatic castration-resistant prostate cancer (mCRPC) with DNA repair defects. | NCT03012321 | Abiraterone/Prednisone, Olaparib, or Abiraterone/Prednisone + Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects BRCAAway: A Randomized Phase II Trial of Abiraterone, Olaparib, or Abiraterone + Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects | - Prostate Cancer Metastatic Castration-Resistant - Abnormal DNA Repair - Metastatic Prostate Carcinoma - Stage IV Prostate Cancer | - Olaparib - Abiraterone Acetate - Prednisone | Phase 2 | Recruiting | 70 (Anticipated) | None (Open Label) | - Objective Progression Free Survival (PFS) | - Measurable disease response rate by RECIST - PSA response rate - Rate of undetectable PSA - Poly[ADP-ribose] polymerase (PARP) inhibition - Incidence of Adverse Events - The post progression response rate with cross over to olaparib or abiraterone - The post progression PFS with cross over to olaparib or abiraterone - Qualitative toxicities (See clinicaltrials.gov for the complete list of secondary endpoints.) | |||||||||||
97 | 95 | AZN | Poster Session | Head and Neck Cancer | Head and Neck Cancer | A phase II/III trial of chemotherapy plus cetuximab versus chemotherapy plus bevacizumab versus atezolizumab plus bevacizumab following progression on immune checkpoint inhibition in recurrent/metastatic head and neck cancers: ECOG-ACRIN EA3202. | NCT05063552 | Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers A Phase II/III Trial of Chemotherapy + Cetuximab vs Chemotherapy + Bevacizumab vs Atezolizumab + Bevacizumab Following Progression on Immune Checkpoint Inhibition in Recurrent/Metastatic Head and Neck Cancers | - Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 - Metastatic Head and Neck Squamous Cell Carcinoma - Metastatic Hypopharyngeal Squamous Cell Carcinoma - Metastatic Laryngeal Squamous Cell Carcinoma - Metastatic Lip and Oral Cavity Carcinoma - Metastatic Nasal Cavity Squamous Cell Carcinoma - Metastatic Nasopharyngeal Squamous Cell Carcinoma - Metastatic Pharyngeal Squamous Cell Carcinoma - Metastatic Sinonasal Squamous Cell Carcinoma - Pathologic Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 (See clinicaltrials.gov for the complete list of conditions.) | - Atezolizumab - Bevacizumab - Carboplatin - Cetuximab - Cisplatin - Docetaxel | Phase 2/Phase 3 | Recruiting | 216 (Anticipated) | None (Open Label) | - Progression free survival (PFS) (Phase II) - Overall survival (OS) (Phase III) | - Overall survival (OS) in the subset of patients with high PD-L1 expression (phase III) - Incidence of adverse events (phase III) - Correlation between 18F-FDG PET and CT neck imaging biomarkers - Prediction of treatment response | |||||||||||
98 | 96 | AZN | Oral Abstract Session | Genitourinary Cancer Kidney and Bladder | Genitourinary Cancer Kidney and Bladder | CALYPSO: A three-arm randomized phase II study of durvalumab alone or with savolitinib or tremelimumab in previously treated advanced clear cell renal cancer. | NCT02819596 | MEDI4736 Combinations in Metastatic Renal Cell Carcinoma MEDI4736 Combinations in Metastatic Renal Cell Carcinoma | - Renal Clear Cell Carcinoma - Renal Papillary Cell Carcinoma | - Savolitinib - MEDI4736 - Tremelimumab | Phase 2 | Active, not recruiting | 181 (Anticipated) | None (Open Label) | - Identify Dose Limiting Toxicity -Phase Ib - Overall response (OR) in patients with metastatic clear cell renal cancer - Overall response (OR) in patients with metastatic Papillary cell renal cancer - Overall response (OR)in patients with metastatic renal cell cancer -Biomarker enrichment phase | - De-escalation phase - PK-Cmax measurement - De-escalation phase - PK-Tmax measurement - De-escalation phase -PK AUC (0-t) measurement - De-escalation phase - PK AUCs measurement - De-escalation phase -PK Css measurement - De-escalation phase -PK Css min measurement - Expansion Phase (IIa) -Identify Progression free survival (PFS) - Expansion Phase (IIa) -Identify overall Survival (OS) (See clinicaltrials.gov for the complete list of secondary endpoints.) | |||||||||||
99 | 97 | AZN | EPZM | Poster Session | Developmental Therapeutics Immunotherapy | Developmental Therapeutics Immunotherapy | CAIRE: A basket multicenter open-label phase 2 study evaluating the EZH2 inhibitor tazemetostat in combination with durvalumab in patients with advanced solid tumors. | NCT04705818 | Combining Epigenetic And Immune Therapy to Beat Cancer. Combining Epigenetic And Immune Therapy to Beat Cancer. CAIRE Study | - Advanced Solid Tumor - Advanced Colorectal Carcinoma - Advanced Soft-tissue Sarcoma - Advanced Pancreatic Adenocarcinoma - Adult Solid Tumor | - Durvalumab - Tazemetostat | Phase 2 | Recruiting | 173 (Anticipated) | None (Open Label) | - Assessment of antitumor activity of durvalumab combined with tazemetostat for cohort A - Assessment of antitumor activity of durvalumab combined with tazemetostat for cohort B - Assessment of antitumor activity of durvalumab combined with tazemetostat for cohort C - Assessment of antitumor activity of durvalumab combined with tazemetostat for cohort D | - Assessment of antitumor activity of durvalumab combined with tazemetostat for cohort D - Assessment of antitumor activity of durvalumab combined with tazemetostat for cohort A - Assessment of antitumor activity of durvalumab combined with tazemetostat for cohort B - Assessment of antitumor activity of durvalumab combined with tazemetostat for cohort C - 6-month objective response (OR) independently for each population - Best overall response, independently for each population - 1-year progression-free survival, independently for each population - 1-year overall survival, independently for each population (See clinicaltrials.gov for the complete list of secondary endpoints.) | ||||||||||
100 | 98 | AZN | Poster Session | Lung Cancer Non-Small Cell Metastatic | Lung Cancer | Open-label, randomized, multicenter, phase 3 study evaluating trastuzumab deruxtecan (T-DXd) as first-line treatment in patients with unresectable, locally advanced, or metastatic non small cell lung cancer (NSCLC) harboring HER2 exon 19 or 20 mutations (DESTINY-Lung04). | NCT05048797 | A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations An Open-label, Randomized, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Trastuzumab Deruxtecan as First-line Treatment of Unresectable, Locally Advanced, or Metastatic NSCLC Harboring HER2 Exon 19 or 20 Mutations (DESTINY-Lung04) | - Locally Advanced or Metastatic Non-Small Cell Lung Cancer | - Trastuzumab Deruxtecan - Cisplatin - Carboplatin - Pembrolizumab - Pemetrexed | Phase 3 | Recruiting | 264 (Anticipated) | None (Open Label) | - Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) | - Overall Survival (OS) - Progression Free Survival (PFS) by investigator assessment - Objective Response Rate (ORR) - Duration of Response (DoR) - Time to second progression or death (PFS2) - Landmark analysis of PFS (PFS12) - Landmark analysis of OS (OS24) - Central Nervous System (CNS) - Progression Free Survival (PFS) (See clinicaltrials.gov for the complete list of secondary endpoints.) |