NCT02563002View on ClinicalTrials.gov

Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177/KEYNOTE-177)

PHASE3CompletedINTERVENTIONAL
Enrollment

307

Participants

Timeline

Start Date

November 30, 2015

Primary Completion Date

February 19, 2021

Study Completion Date

July 17, 2023

Conditions
Colorectal Carcinoma
Interventions
DRUG

mFOLFOX6

Regimen consists of oxaliplatin 85 mg/m\^2 IV on Day 1, leucovorin 400 mg/m\^2 or levoleucovorin 200 mg/m\^2 IV on Day 1, 5-fluorouracil (5-FU) 400 mg/m\^2 IV bolus on Day 1 and then 1200 mg/m\^2/day IV over 2 days for total dose of 2400 mg/m\^2 in each 2-week cycle

DRUG

FOLFIRI

Regimen consists of irinotecan 180 mg/m\^2 IV on Day 1, leucovorin 400 mg/m\^2 or levoleucovorin 200 mg/m\^2 IV on Day 1, 5-FU 400 mg/m\^2 IV bolus on Day 1 and then 1200 mg/m\^2/day IV over 2 days for total dose of 2400 mg/m\^2 in each 2-week cycle

BIOLOGICAL

Pembrolizumab

IV infusion

BIOLOGICAL

Bevacizumab

IV infusion

BIOLOGICAL

Cetuximab

IV infusion

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT02563002 - Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177/KEYNOTE-177) | Biotech Hunter | Biotech Hunter