MK-4280A
Sponsors
Merck Sharp & Dohme LLC
Conditions
Advanced esophageal squamous cell carcinoma (ESCC)Advanced tumorsColorectal CancerHematologic MalignanciesNeoplasm malignantNon-Muscle Invasive Bladder Cancer (NMIBC)PD-1 refractory melanomaParticipants with Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer
Phase 1
A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants with RCC (KEYMAKER-U03): Substudy 03A in First Line Metastatic Participants
RecruitingCTIS2023-506838-68-00
Start: 2020-12-10Target: 62Updated: 2025-11-07
A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants with Melanoma (KEYMAKER-U02): Substudy 02C
CompletedCTIS2023-506314-51-00
Start: 2020-07-31End: 2025-09-09Target: 29Updated: 2025-09-09
A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizuma Alone in Participants With Melanoma (KEYMAKER-U02): Substudy 02B
RecruitingCTIS2023-506313-21-00
Start: 2020-08-03Target: 71Updated: 2025-11-21
A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants with RCC (KEYMAKER-U03): substudy 03B in Second-Line Metastatic Participants
Active, not recruitingCTIS2023-506839-15-00
Start: 2020-12-21Target: 68Updated: 2025-11-26
A Phase 1b/2 Study to Evaluate the Efficacy and Safety of Investigational Agents as Monotherapy or in Combination With Pembrolizumab for the Treatment of Participants With PD-1/L1-refractory Extensive-Stage Small Cell Lung Cancer in Need of Second-Line Therapy (KEYNOTE-B98)
Active, not recruitingCTIS2023-507687-38-00
Start: 2021-08-23Target: 59Updated: 2026-01-09
A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer naïve to PD-1/PD-L1 Treatment (KEYMAKER-U06): Substudy 06A
CompletedCTIS2023-505188-36-00
Start: 2022-09-09End: 2025-09-03Target: 20Updated: 2025-10-20
Phase 2
A Phase II Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) and Pembrolizumab in Combination with Other Investigational Agents in Subjects with High-risk Non-muscle-Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy
CompletedCTIS2022-502526-41-00
Start: 2016-03-15End: 2025-11-05Target: 102Updated: 2025-09-08
A Phase 2 Randomized Clinical Study of MK-4280A (coformulated favezelimab [MK-4280] plus pembrolizumab [MK-3475]) Versus Physician’s Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (KEYFORM-008)
CompletedCTIS2023-503615-14-00
Start: 2022-09-29End: 2025-12-31Target: 54Updated: 2026-01-27
A Phase 2, Multicenter, Multi Arm, Study to Evaluate MK-1308A (Coformulated quavonlimab (MK-1308)/pembrolizumab) Versus Other Treatments in Participants with Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer: (MK-1308A-008)
Active, not recruitingCTIS2022-502100-70-00
Start: 2021-06-23Target: 244Updated: 2026-01-27
A Multicenter, Randomized, Double-Blind, Phase 2, Basket Study of MK-4280A, a Coformulation of Favezelimab (MK-4280) with Pembrolizumab (MK-3475) in Selected Solid Tumors (KeyForm-010)
Active, not recruitingCTIS2023-505022-34-00
Start: 2024-03-27Target: 19Updated: 2025-12-05
Phase 3
Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)
RecruitingNCT03486873
Start: 2018-08-21End: 2043-08-04Target: 3500Updated: 2026-03-16
A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety and Efficacy in Participants who are Currently on Treatment or in Follow-up in Studies That Include Pembrolizumab
RecruitingCTIS2022-501254-10-00
Start: 2018-08-24Target: 1252Updated: 2025-11-17
A Phase 3 study of MK-4280A (coformulated favezelimab [MK-4280] plus pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PD-L1 positive Colorectal Cancer (KEYFORM-007)
CompletedCTIS2024-511043-25-00
Start: 2021-11-30End: 2025-02-21Target: 102Updated: 2025-02-04