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Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Chinese Participants With Stage IV Colorectal Cancer (MK-3475-C66) | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

A Phase 3 Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Chinese Participants With Stage IV Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer (MK-3475-C66)

NCT05239741•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 biopsy of a tumor lesion not previously irradiated.
•Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 3 days before randomization
•Has a life expectancy of at least 3 months
•Has received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable hepatitis B virus (HBV) viral load prior to randomization if hepatitis B surface antigen (HBsAg) positive
•Has an undetectable Hepatitis C Virus (HCV) viral load if HCV infected
+1 more criteria

Exclusion Criteria

•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
•Has undergone major operation within 4 weeks of randomization or has not adequately recovered from major surgery or has ongoing surgical complications
•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 \[CD137\])
•Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicities, requiring corticosteroids
•Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
•Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
•Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
•Has a known additional malignancy that is progressing or has required active treatment within the past 5 years, with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded
•Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
•Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
+5 more criteria

Locations (32)

Beijing Cancer hospital-Digestive Oncology ( Site 0001)

Beijing, Beijing Municipality, China

Beijing Peking Union Medical College Hospital-Medical Oncology ( Site 0011)

Beijing, Beijing Municipality, China

Tianjin Medical University Cancer Institute and Hospital-Gastric oncology ( Site 0019)

Tianjin, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University ( Site 0051)

Chongqing, Chongqing Municipality, China

Chongqing University Cancer Hospital-Medical Oncology ( Site 0012)

Chongqing, Chongqing Municipality, China

Fujian Provincial Cancer Hospital ( Site 0009)

Fuzhou, Fujian, China

Sun Yat-sen University Cancer Center ( Site 0047)

Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital ( Site 0035)

Guangzhou, Guangdong, China

The First Affiliated Hospital, Sun Yat-sen University ( Site 0014)

Guangzhou, Guangdong, China

The Sixth Affiliated Hospital of Sun Yat-sen University-Oncology ( Site 0048)

Guangzhou, Guangdong, China

Key Dates

Start Date

April 2, 2022

Primary Completion Date

September 19, 2028

Completion Date

September 19, 2028

Last Updated

March 10, 2026

Enrollment

100

ESTIMATED participants

Conditions

Colorectal Neoplasms

Interventions

Pembrolizumab

BIOLOGICAL

Oxaliplatin

DRUG

Leucovorin

DRUG

5-fluorouracil

DRUG

Irinotecan

DRUG

Bevacizumab

BIOLOGICAL

Cetuximab

BIOLOGICAL

Contacts

Toll Free Number

CONTACT

1-888-577-8839 Trialsites@msd.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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