Trials / Active Not Recruiting
Active Not RecruitingNCT04895722
Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008)
A Phase 2, Multicenter, Multi Arm, Study to Evaluate MK-1308A (Co-formulated Quavonlimab (MK-1308)/Pembrolizumab) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer: (MK-1308A-008)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 302 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the efficacy and safety of co-formulated pembrolizumab/quavonlimab versus other treatments in participants with MSI-H or dMMR Metastatic Stage IV Colorectal Cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Pembrolizumab | 400 mg or 200 mg pembrolizumab administered via IV infusion. |
| BIOLOGICAL | Pembrolizumab/Quavonlimab | Co-formulated pembrolizumab/quavonlimab (400 mg/25 mg) fixed-dose combination (FDC) administered via IV infusion. |
| BIOLOGICAL | Pembrolizumab/Favezelimab | Co-formulated pembrolizumab/favezelimab (200 mg/800 mg) FDC administered via IV infusion |
| BIOLOGICAL | Pembrolizumab/Vibostolimab | Co-formulated pembrolizumab/vibostolimab (200 mg/200 mg) FDC administered via IV infusion |
| BIOLOGICAL | MK-4830 | 800 mg MK-4830 administered via IV infusion |
Timeline
- Start date
- 2021-06-25
- Primary completion
- 2025-05-21
- Completion
- 2026-08-13
- First posted
- 2021-05-20
- Last updated
- 2026-03-30
Locations
109 sites across 22 countries: United States, Belgium, Canada, Colombia, Costa Rica, Denmark, Estonia, France, Germany, Greece, Guatemala, Hungary, Italy, Lithuania, Netherlands, Poland, Romania, Russia, South Korea, Spain, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04895722. Inclusion in this directory is not an endorsement.