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MK-1084

DRUG10 trials

Sponsors

Merck Sharp & Dohme LLC

Conditions

Advanced Solid TumorsAdvanced or Metastatic Nonsquamous NSCLCCompletely resected Stage IIA-IIIB (N2) KRAS G12C mutated NSCLCKRAS G12C-mutantLocally Advanced Unresectable or Metastatic Colorectal CancerLung Neoplasm MalignantMalignant NeoplasmMetastatic Solid Tumors

Phase 1

Phase 2

Phase 3

A Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic NSCLC With PD-L1 TPS ≥50% (KANDLELIT-004)
RecruitingCTIS2023-507776-42-00
Merck Sharp & Dohme LLCNon-small cell lung cancer
Start: 2024-11-14Target: 194Updated: 2025-12-19
A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 versus mFOLFOX6 With or Without Bevacizumab as First-line Treatment of Participants With KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer (KANDLELIT-012).
RecruitingCTIS2024-517232-22-00
Merck Sharp & Dohme LLCKRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer
Start: 2025-09-26Target: 141Updated: 2026-01-06
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
A Phase 3, Randomized, Double-blind Study of Adjuvant MK-1084 Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) versus Adjuvant Placebo Plus MK-3475A in Participants with Completely Resected Stage IIA-IIIB (N2), KRAS G12C-mutant Non-small Cell Lung Cancer following Receipt of Either Neoadjuvant Pembrolizumab Plus Chemotherapy or Adjuvant Chemotherapy (KANDLELIT-013)
Not yet recruitingCTIS2024-517337-41-00
Merck Sharp & Dohme LLCCompletely resected Stage IIA-IIIB (N2) KRAS G12C mutated NSCLC
Target: 36Updated: 2026-04-20