A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Pfizer
Study ID
NCT05217446
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • Encorafenib — DRUG
    capsule
  • Cetuximab — BIOLOGICAL
    IV
  • Pembrolizumab — BIOLOGICAL
    IV

Study Details

The purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that: * is metastatic (spread to other parts of the body); * has the condition of genetic hypermutability (tendency to mutation) or impaired DNA mismatch repair (MMR) * has a certain type of abnormal gene called "BRAF" and; * has not received prior treatment. All participants in this study will receive pembrolizumab at the study clinic as an intravenous (IV) infusion (given directly into a vein) at the study clinic. In addition, half of the participants will take encorafenib by mouth at home every day and cetuximab by IV infusion at the study clinic. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.

Key Dates

Start date
Jul 11, 2022
Status verified
Apr 2026
Primary completion
Jun 1, 2026
Completion
Jan 26, 2027

Study Design

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

Arms

  • Experimental: Arm A: encorafenib, cetuximab and pembrolizumab
    Participants receive encorafenib orally + cetuximab IV + pembrolizumab IV.
  • Active Comparator: Arm B: pembrolizumab
    Participants receive pembrolizumab IV.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Duration of study, approximately 45 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
Mayo Clinic Building - PhoenixPhoenixArizona85054-
Mayo Clinic HospitalPhoenixArizona85054-
Mayo ClinicScottsdaleArizona85259-
Mount Sinai Cancer CenterMiami BeachFlorida33140-
The West Clinic, PLLC dba West Cancer CenterGermantownTennessee38138-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic Building - Phoenix· Phoenix, AZMayo Clinic Hospital· Phoenix, AZMayo Clinic· Scottsdale, AZMount Sinai Cancer Center· Miami Beach, FLThe West Clinic, PLLC dba West Cancer Center· Germantown, TNMD Anderson Cancer Center· Houston, TX

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