A Phase 2, Multicenter, Multi Arm, Study to Evaluate MK-1308A (Coformulated 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

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502100-70-00

Acronym

MK-1308A-008

Enrollment

244

Registered

2023-08-31

Start date

2021-06-23

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Participants with Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer

Brief summary

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)

Detailed description

Duration of Response (DOR) per RECIST 1.1 as assessed by BICR, Progression-Free Survival (PFS) per RECIST 1.1 as assessed by BICR, PFS per RECIST 1.1 as assessed by Investigator, ORR per RECIST 1.1 as assessed by Investigator, DOR per RECIST 1.1 as assessed by Investigator, Overall Survival (OS), Number of Participants Who Experienced an Adverse Event (AE), Number of Participants Discontinuing Study Treatment Due to an AE

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGMK-7684A

DRUGMK-4280A

DRUGMK-1308A

DRUGMK-4830

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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)	—

Secondary

Measure	Time frame
Duration of Response (DOR) per RECIST 1.1 as assessed by BICR, Progression-Free Survival (PFS) per RECIST 1.1 as assessed by BICR, PFS per RECIST 1.1 as assessed by Investigator, ORR per RECIST 1.1 as assessed by Investigator, DOR per RECIST 1.1 as assessed by Investigator, Overall Survival (OS), Number of Participants Who Experienced an Adverse Event (AE), Number of Participants Discontinuing Study Treatment Due to an AE	—

Measure

Time frame

—

Countries

Belgium, Denmark, Estonia, France, Germany, Greece, Hungary, Italy, Lithuania, Netherlands, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026