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Recruiting Phase 3 NCT05239741

Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Chinese Participants With Stage IV Colorectal Cancer (MK-3475-C66)

Trial Parameters

Condition Colorectal Neoplasms
Sponsor Merck Sharp & Dohme LLC
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-04-02
Completion 2028-09-19
Interventions
PembrolizumabOxaliplatinLeucovorin

Brief Summary

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.

Eligibility Criteria

The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: Inclusion Criteria include, but are not limited to: * Has a histologically confirmed diagnosis of colorectal adenocarcinoma that is at stage IV (as defined by American Joint Committee on Cancer eighth edition) \[National Comprehensive Cancer Network 2018\] * Has centrally confirmed Microsatellite Instability-High/Mismatch Repair Deficient (MSI-H/dMMR) status * Has centrally confirmed RAS and BRAF mutation status * A woman of child-bearing potential (WOCBP) must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours for urine or within 72 hours for serum before the first dose of study intervention. * Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by the local site investigator/radiology * Must provide an archival tumor tissue sample or newly obtained core or excisional biop

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