MK-1084
Sponsors
Merck Sharp & Dohme LLC
Conditions
Advanced Solid TumorsAdvanced or Metastatic Nonsquamous NSCLCKRAS G12C-mutantLocally Advanced Unresectable or Metastatic Colorectal CancerLung Neoplasm MalignantMalignant NeoplasmMetastatic Solid TumorsNeoplasm malignant with KRAS G12C mutation
Phase 1
Study of MK-0472 in Participants With Advanced/Metastatic Solid Tumors (MK-0472-001)
RecruitingNCT05853367
Start: 2023-07-06End: 2028-02-12Target: 178Updated: 2026-03-13
A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F)
RecruitingNCT07286149
Start: 2026-03-23End: 2037-05-06Target: 190Updated: 2026-03-16
Protocol Title: KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Previously Treated of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations
Not yet recruitingCTIS2024-512248-47-00
Target: 32Updated: 2026-03-05
Phase 2
A Phase 2, Open-Label, Multicenter, Tumor-agnostic Study of MK-1084 as Monotherapy and in Combination with Cetuximab, in Participants with KRAS G12C-Mutant, Advanced Solid Tumors (KANDLELIT-014)
RecruitingCTIS2025-521737-91-00
Start: 2025-11-25Target: 74Updated: 2025-11-17
KEYMAKER-U01 Substudy 01J: A Study of Pembrolizumab Plus MK-1084 in Participants With Non-Small Cell Lung Cancer (NSCLC) With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) G12C Mutations (MK-3475-01J/KEYMAKER-U01J)
RecruitingNCT07252739
Start: 2025-12-19End: 2033-01-14Target: 130Updated: 2026-03-31
KEYMAKER-U01 Substudy 01J: A Randomized Phase 2 Umbrella Study With Rolling Arms of Investigational Agents for First-line Treatment of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations
Not yet recruitingCTIS2025-521939-36-00
Target: 15Updated: 2026-02-25
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
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
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
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
Start: 2026-03-18End: 2039-10-26Target: 400Updated: 2026-04-03