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).
Phase 2
Active, not recruiting
NCT04895722
| Condition | Colorectal Cancer |
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| Phase | Phase 2 |
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| Sponsor | Merck Sharp & Dohme LLC |
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| Status | Active, not recruiting |
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| Enrollment | 302 participants |
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| Interventions | Pembrolizumab, Pembrolizumab/Quavonlimab, Pembrolizumab/Favezelimab, Pembrolizumab/Vibostolimab, MK-4830 |
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| Start date | Jun 25, 2021 |
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| Completion date | May 21, 2025 |
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| Results posted | Jun 8, 2026 |
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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.
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Up to approximately 46 months · Percentage of Participants
| Cohort A - Pembrolizumab/Quavonlimab | 45.0 Percentage of Participants |
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| Cohort A - Pembrolizumab | 29.5 Percentage of Participants |
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| Cohort B - Pembrolizumab/Quavonlimab | 46.2 Percentage of Participants |
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| Cohort B - Pembrolizumab Plus MK-4830 | 65.0 Percentage of Participants |
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| Cohort B - Pembrolizumab/Favezelimab | 37.5 Percentage of Participants |
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| Cohort B - Pembrolizumab/Vibostolimab | 48.8 Percentage of Participants |
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| Difference in Percentage | 15.6 (95% CI -1.7–32.1) |
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Open in BENITIONS
View on ClinicalTrials.gov
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