Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Chinese Participants With Stage IV Colorectal Cancer (MK-3475-C66)
NCT ID: NCT05239741
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
100 participants
INTERVENTIONAL
2022-04-02
2028-09-19
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pembrolizumab
Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 treatments (approximately 2 years).
Pembrolizumab
Intravenous (IV) infusion
Standard of Care Chemotherapy
Participants receive 1 of 6 possible standard chemotherapy regimens at the discretion of the investigator: (1) mFOLFOX6; (2) mFOLFOX6+bevacizumab 5 mg/kg IV on Day 1 of each 14-day cycle (Q2W); (3) mFOLFOX6+cetuximab 400 mg/m\^2 IV over 2 hours then 250 mg/m\^2 over 1 hour weekly Q2W; (4) FOLFIRI; (5) FOLFIRI+bevacizumab 5 mg/kg IV on Day 1 Q2W; OR (6) FOLFIRI+cetuximab 400 mg/m\^2 IV over 2 hours then 250 mg/m\^2 over 1 hour weekly Q2W. Participants with documented disease progression following chemotherapy can receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 treatments (approximately 2 years).
Oxaliplatin
85 mg/m\^2 given as an intravenous infusion (IV) on Day 1 in each 14-day cycle (Q2W) as part of the mFOLFOX6 regimen
Leucovorin
400 mg/m\^2 given as an IV on Day 1 Q2W as part of the mFOLFOX6 and FOLFIRI regimens
5-fluorouracil
400 mg/m\^2 given as an IV bolus on Day 1 and then 1200 mg/m\^2/day IV over 2 days for a total dose of 2400 mg/m\^2 Q2W as part of the mFOLFOX6 and FOLFIRI regimens
Irinotecan
180 mg/m\^2 IV on Day 1 Q2W as part of the FOLFIRI regimen
Bevacizumab
IV infusion
Cetuximab
IV infusion
Interventions
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Pembrolizumab
Intravenous (IV) infusion
Oxaliplatin
85 mg/m\^2 given as an intravenous infusion (IV) on Day 1 in each 14-day cycle (Q2W) as part of the mFOLFOX6 regimen
Leucovorin
400 mg/m\^2 given as an IV on Day 1 Q2W as part of the mFOLFOX6 and FOLFIRI regimens
5-fluorouracil
400 mg/m\^2 given as an IV bolus on Day 1 and then 1200 mg/m\^2/day IV over 2 days for a total dose of 2400 mg/m\^2 Q2W as part of the mFOLFOX6 and FOLFIRI regimens
Irinotecan
180 mg/m\^2 IV on Day 1 Q2W as part of the FOLFIRI regimen
Bevacizumab
IV infusion
Cetuximab
IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Has well controlled Human Immunodeficiency Virus (HIV) on antiretroviral therapy (ART) if HIV infected
Exclusion Criteria
* 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
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has an active infection requiring systemic therapy (eg, tuberculosis, known viral or bacterial infection)
* Has HIV-infection with a history of Kaposi's sarcoma or Multicentric Castleman's Disease
* Has had an allogenic tissue/solid organ transplant
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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
Cancer Hospital of Shantou University Medical College ( Site 0036)
Shantou, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital ( Site 0039)
Nanning, Guangxi, China
Harbin Medical University Cancer Hospital ( Site 0007)
Harbin, Heilongjiang, China
Henan Cancer Hospital-henan cancer hospital ( Site 0015)
Zhengzhou, Henan, China
Tongji Hospital Tongji Medical,Science & Technology-oncology ( Site 0018)
Wuhan, Hubei, China
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 0008)
Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University ( Site 0031)
Changsha, Hunan, China
The Affiliated Jiangyin Hospital of Southeast University Medical College ( Site 0037)
Jiangyin, Jiangsu, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology ( Site 0002)
Nanjing, Jiangsu, China
The first affiliated hospital of China medical university ( Site 0043)
Shemyang, Liaoning, China
Tangdu Hospital of Fourth Military Medical University of Chi-General Surgery ( Site 0045)
Xi'an, Shaanxi, China
Jinan Central Hospital-oncology department ( Site 0021)
Jinan, Shandong, China
Shandong Cancer Hospital ( Site 0041)
Jinan, Shandong, China
Fudan University Shanghai Cancer Center-Oncology ( Site 0046)
Shanghai, Shanghai Municipality, China
Shanghai East Hospital ( Site 0022)
Shanghai, Shanghai Municipality, China
Shanghai Changhai Hospital ( Site 0024)
Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital ( Site 0032)
Taiyuan, Shanxi, China
Sichuan Cancer Hospital. ( Site 0050)
Chengdu, Sichuan, China
West China Hospital, Sichuan University ( Site 0044)
Chengdu, Sichuan, China
The Affiliated Cancer Hospital of Xinjiang Medical University ( Site 0049)
Ürümqi, Xinjiang, China
Yunnan Province Cancer Hospital-Colorectal surgery ( Site 0006)
Kunming, Yunnan, China
Zhejiang Cancer Hospital-oncology-abdominal neoplasms ( Site 0028)
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-3475-C66
Identifier Type: OTHER
Identifier Source: secondary_id
3475-C66
Identifier Type: -
Identifier Source: org_study_id