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RECRUITING
NCT05239741
PHASE3

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

Sponsor: 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.

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

Interventions

BIOLOGICAL

Pembrolizumab

Intravenous (IV) infusion

DRUG

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

DRUG

Leucovorin

400 mg/m\^2 given as an IV on Day 1 Q2W as part of the mFOLFOX6 and FOLFIRI regimens

DRUG

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

DRUG

Irinotecan

180 mg/m\^2 IV on Day 1 Q2W as part of the FOLFIRI regimen

BIOLOGICAL

Bevacizumab

IV infusion

BIOLOGICAL

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