MK-3475A

DRUG5 trials

Sponsors

Merck Sharp & Dohme LLC

Conditions

Advanced or Metastatic Nonsquamous NSCLCFirst-line treatment of participants with metastatic nonsmall cell lung cancerMelanomaNon-small Cell Lung CancerNon-small cell lung cancerParticipants with KRAS G12C-MutantRelapsed or Refractory Classical Hodgkin’s Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)Renal Cell Carcinoma

Phase 2

A Phase 2 Study to Evaluate Patient Reported Preference for Subcutaneous Pembrolizumab Coformulated with Hyaluronidase (MK-3475A) Over Intravenous Pembrolizumab Formulation in Participants With Multiple Tumor Types (MK-3475A-F11)

Active, not recruitingCTIS2023-506017-22-00

Merck Sharp & Dohme LLCMelanoma, Non-small cell lung cancer, Renal Cell Carcinoma

Start: 2024-02-16Target: 44Updated: 2025-10-16

A Phase 2 Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) in Participants with Relapsed or Refractory Classical Hodgkin Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)

Active, not recruitingCTIS2024-510969-42-00

Merck Sharp & Dohme LLCRelapsed or Refractory Classical Hodgkin’s Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)

Start: 2024-09-30Target: 30Updated: 2025-09-19

Phase 3

A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Versus Intravenous Pembrolizumab, Administered With Chemotherapy, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer

Active, not recruitingCTIS2022-501506-36-00

Merck Sharp & Dohme LLCFirst-line treatment of participants with metastatic nonsmall cell lung cancer

Start: 2023-04-11Target: 100Updated: 2025-08-20

A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)

RecruitingCTIS2024-514500-14-00

Merck Sharp & Dohme LLCAdvanced or Metastatic Nonsquamous NSCLC, Participants with KRAS G12C-Mutant

Start: 2025-12-15Target: 206Updated: 2026-01-19

MK-3475A±MK-1084 in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)

RecruitingNCT07431827

Merck Sharp & Dohme LLCNon-small Cell Lung Cancer

Start: 2026-03-18End: 2039-10-26Target: 400Updated: 2026-04-03