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

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT05239741
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — BIOLOGICAL
    Intravenous (IV) infusion
  • Oxaliplatin — DRUG
    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 — DRUG
    400 mg/m\^2 given as an IV on Day 1 Q2W as part of the mFOLFOX6 and FOLFIRI regimens
  • 5-fluorouracil — DRUG
    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 — DRUG
    180 mg/m\^2 IV on Day 1 Q2W as part of the FOLFIRI regimen
  • Bevacizumab — BIOLOGICAL
    IV infusion
  • Cetuximab — BIOLOGICAL
    IV infusion

Study Details

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.

Key Dates

Start date
Apr 2, 2022
Status verified
May 2026
Primary completion
Sep 19, 2028
Completion
Sep 19, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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).
  • Active Comparator: 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).

Primary Outcome Measure

Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) For All Participants [ Time Frame: Up to approximately 77 months ]

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