NCT05239741

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Neoplasms

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-04-02
• Primary completion: 2028-09-19
• Completion: 2028-09-19
• First posted: 2022-02-15
• Last updated: 2026-04-17

Locations

32 sites across 1 country: China

Regulatory

• FDA-regulated drug study