A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT05064059
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • favezelimab/pembrolizumab — BIOLOGICAL
    Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion
  • regorafenib — DRUG
    Oral
  • TAS-102 — DRUG
    Oral

Study Details

The purpose of this study is to assess the safety and efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) in participants with metastatic colorectal cancer. The study will also compare MK-4280A with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil). The primary study hypothesis is that coformulated favezelimab/pembrolizumab (MK-4280A) is superior to standard of care with respect to overall survival.

Key Dates

Start date
Nov 10, 2021
Status verified
May 2026
Primary completion
Aug 15, 2024
Completion
Feb 21, 2025

Study Design

Enrollment
441 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Favezelimab/Pembrolizumab
    Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions.
  • Active Comparator: Standard of Care (Regorafenib or TAS-102)
    At the Investigator's choice, participants will receive 160 mg regorafenib orally daily on Days 1-12 of each 28-day cycle or 35 mg/m\^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to approximately 33 months ]

Locations (15)

FacilityCityStateZIP
Georgetown University Hospital ( Site 1148)Washington D.C.District of Columbia20007
Sibley Memorial Hospital ( Site 1143)Washington D.C.District of Columbia20016
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1118)MariettaGeorgia30060
Norton Cancer Institute ( Site 1139)LouisvilleKentucky40217
Rutgers Cancer Institute of New Jersey ( Site 1105)New BrunswickNew Jersey08903
Memorial Sloan Kettering Cancer Center ( Site 1703)New YorkNew York10065
Oregon Health & Science University ( Site 1141)PortlandOregon97239
MUSC Hollings Cancer Center ( Site 1715)CharlestonSouth Carolina29425
The West Clinic, PLLC dba West Cancer Center ( Site 1149)GermantownTennessee38138
UT Southwestern Medical Center ( Site 1709)DallasTexas75390-9063
Intermountain Medical Center ( Site 1707)MurrayUtah84107
Inova Schar Cancer Institute ( Site 1130)FairfaxVirginia22031
VCU Health Adult Outpatient Pavillion ( Site 1712)RichmondVirginia23219
Blue Ridge Cancer Care ( Site 1718)RoanokeVirginia24014
Seattle Cancer Care Alliance ( Site 1107)SeattleWashington98109

Related coverage on Hipa.ai

Find similar trials in Washington D.C., DC

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Georgetown University Hospital ( Site 1148)· Washington D.C., DCSibley Memorial Hospital ( Site 1143)· Washington D.C., DCNorthwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1118)· Marietta, GANorton Cancer Institute ( Site 1139)· Louisville, KYRutgers Cancer Institute of New Jersey ( Site 1105)· New Brunswick, NJMemorial Sloan Kettering Cancer Center ( Site 1703)· New York, NY

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