OncoMatch/Clinical Trials/NCT05239741
Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Chinese Participants With Stage IV Colorectal Cancer (MK-3475-C66)
Is NCT05239741 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for colorectal neoplasms.
Treatment: Pembrolizumab · Oxaliplatin · Leucovorin · 5-fluorouracil · Irinotecan · Bevacizumab · Cetuximab — In this study, Chinese participants with MSI-H or dMMR advanced colorectal cancer will be assigned to receive either pembrolizumab or the Investigator's choice of 1 of 6 standard of care (SOC) chemotherapy regimens for treatment. There is no hypothesis testing for this study.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS mutation status known
Has centrally confirmed RAS and BRAF mutation status
Required: NRAS mutation status known
Has centrally confirmed RAS and BRAF mutation status
Required: BRAF mutation status known
Has centrally confirmed RAS and BRAF mutation status
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Exception: adjuvant/neoadjuvant chemotherapy for CRC as long as it was completed at least 6 months prior to randomization
Has received prior systemic therapy for stage IV colorectal cancer (CRC). Participants may have received prior adjuvant/neoadjuvant chemotherapy for CRC as long as it was completed at least 6 months prior to randomization
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
Has received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], tumor necrosis factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9 [CD137])
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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