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Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Chinese Participants With Stage IV Colorectal Cancer (MK-3475-C66)
Sponsor: Merck Sharp & Dohme LLC
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2022-04-02
Completion Date
2028-09-19
Last Updated
2026-03-10
Healthy Volunteers
No
Conditions
Interventions
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
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
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
Shanghai East Hospital ( Site 0022)
Shanghai, Shanghai Municipality, China
Shanghai Changhai Hospital ( Site 0024)
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center-Oncology ( Site 0046)
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