Trials / Completed
CompletedNCT02563002
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)
A Phase III Study of Pembrolizumab (MK-3475) vs. Chemotherapy in Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (KEYNOTE-177)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 307 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
In this study, participants with stage IV Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) colorectal carcinoma (CRC) will be randomly assigned to receive either pembrolizumab or the Investigator's choice of 1 of 6 standard of care (SOC) chemotherapy regimens for the treatment of advanced colorectal carcinoma. The primary study hypothesis is that pembrolizumab will prolong progression-free survival (PFS) or overall survival (OS) compared to current SOC chemotherapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2015-11-30
- Primary completion
- 2021-02-19
- Completion
- 2023-07-17
- First posted
- 2015-09-29
- Last updated
- 2024-10-03
- Results posted
- 2022-03-16
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02563002. Inclusion in this directory is not an endorsement.