RecruitingPhase 3NCT05239741

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)


Sponsor

Merck Sharp & Dohme LLC

Enrollment

100 participants

Start Date

Apr 2, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial compares pembrolizumab (an immunotherapy drug) versus standard chemotherapy as the first treatment for Chinese patients with stage IV colorectal cancer that has a specific genetic marker called MSI-H or dMMR, which makes tumors more likely to respond to immunotherapy. **You may be eligible if...** - You are 18 or older with stage IV colorectal cancer confirmed by biopsy - Your tumor has been confirmed to have the MSI-H or dMMR genetic feature - You have measurable disease on imaging - You are in generally good health (ECOG 0 or 1) - You have a life expectancy of at least 3 months **You may NOT be eligible if...** - You have already received treatment for advanced colorectal cancer - You have active autoimmune disease - You have uncontrolled HIV, or active hepatitis B or C - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALPembrolizumab

Intravenous (IV) infusion

DRUGOxaliplatin

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

DRUGLeucovorin

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

DRUG5-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

DRUGIrinotecan

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

BIOLOGICALBevacizumab

IV infusion

BIOLOGICALCetuximab

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 Changhai Hospital ( Site 0024)

Shanghai, Shanghai Municipality, China

Shanghai East Hospital ( Site 0022)

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05239741


Related Trials