BENITIONSClinical Trial Intelligence

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).

Фаза 2 Идёт, набор закрыт NCT04895722

ЗаболеваниеColorectal Cancer
ФазаФаза 2
СпонсорMerck Sharp & Dohme LLC
СтатусИдёт, набор закрыт
Участники302 участн.
ВмешательствоPembrolizumab, Pembrolizumab/Quavonlimab, Pembrolizumab/Favezelimab, Pembrolizumab/Vibostolimab, MK-4830
Дата начала25.06.2021
Дата завершения21.05.2025
Публикация результатов8.06.2026

Кратко

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/Quavonlimab45.0 Percentage of Participants
Cohort A - Pembrolizumab29.5 Percentage of Participants
Cohort B - Pembrolizumab/Quavonlimab46.2 Percentage of Participants
Cohort B - Pembrolizumab Plus MK-483065.0 Percentage of Participants
Cohort B - Pembrolizumab/Favezelimab37.5 Percentage of Participants
Cohort B - Pembrolizumab/Vibostolimab48.8 Percentage of Participants
Difference in Percentage15.6 (95% CI -1.7–32.1)

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