{"entity":{"id":"nct04895722","kind":"trial","name":"Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) ","aka":[],"tldr":"A phase 2 trial of Pembrolizumab, Favezelimab in colorectal cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"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). is a phase 2 interventional study registered as NCT04895722 by Merck Sharp & Dohme LLC, with 302 participants enrolled, started 2021-06-25 and due to reach its primary completion in 2025-05-21. Interventions recorded: Pembrolizumab, Pembrolizumab/Quavonlimab, Pembrolizumab/Favezelimab, Pembrolizumab/Vibostolimab, MK-4830. Conditions listed: Colorectal Cancer. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04895722","url":"https://clinicaltrials.gov/study/NCT04895722"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","favezelimab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04895722","phase":"2","setting":"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)","sponsor":"Merck Sharp & Dohme LLC","started":"2021-06-25","startedType":"actual","yearReported":2026,"enrolled":302,"enrolledBasis":"registry","outcomes":[{"endpoint":"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)","primary":true,"unit":"%","arms":[{"name":"Cohort A - Pembrolizumab/Quavonlimab","n":60,"value":45,"note":"95% CI 32.1 to 58.4; Figures from the ClinicalTrials.gov results section (first posted 2026-06-08), not from a publication"},{"name":"Cohort A - Pembrolizumab","n":61,"value":29.5,"note":"95% CI 18.5 to 42.6"},{"name":"Cohort B - Pembrolizumab/Quavonlimab","n":39,"value":46.2,"note":"95% CI 30.1 to 62.8"},{"name":"Cohort B - Pembrolizumab Plus MK-4830","n":20,"value":65,"note":"95% CI 40.8 to 84.6"},{"name":"Cohort B - Pembrolizumab/Favezelimab","n":40,"value":37.5,"note":"95% CI 22.7 to 54.2"},{"name":"Cohort B - Pembrolizumab/Vibostolimab","n":41,"value":48.8,"note":"95% CI 32.9 to 64.9"},{"name":"Cohort B - Pembrolizumab","n":41,"value":41.5,"note":"95% CI 26.3 to 57.9"}],"source":"https://clinicaltrials.gov/study/NCT04895722?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Cohort A - Pembrolizumab/Quavonlimab","n":60,"note":"NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.; Figures from the ClinicalTrials.gov results section (first posted 2026-06-08), not from a publication"},{"name":"Cohort A - Pembrolizumab","n":61,"value":37.1,"note":"95% CI 14.4 to NA"},{"name":"Cohort B - Pembrolizumab/Quavonlimab","n":39,"note":"NA = Median, upper limit, and lower limit not reached at time of data cut-off due to insufficient number of participants with an event."},{"name":"Cohort B - Pembrolizumab Plus MK-4830","n":20,"note":"NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event."},{"name":"Cohort B - Pembrolizumab/Favezelimab","n":40,"note":"NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event."},{"name":"Cohort B - Pembrolizumab/Vibostolimab","n":41,"note":"NA = Median, upper limit, and lower limit not reached at time of data cut-off due to insufficient number of participants with an event."},{"name":"Cohort B - Pembrolizumab","n":41,"note":"NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event."}],"source":"https://clinicaltrials.gov/study/NCT04895722?tab=results"}]},"route":"/trials/nct04895722/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"msi-high-colorectal","kind":"cancer","name":"Mismatch-repair deficient (MSI-high) colorectal cancer","route":"/cancers/msi-high-colorectal/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"favezelimab","kind":"drug","name":"Favezelimab","route":"/drugs/favezelimab/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"merck","kind":"company","name":"Merck & Co. (MSD)","route":"/companies/merck/"}]}}