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Colon CancerOpen to EnrollmentPhase 2

COLON: METASTATIC: BRAFmt: MSI-h: 1st Line: SEAMARK

A PHASE 2, RANDOMIZED, OPEN-LABEL STUDY OF ENCORAFENIB AND CETUXIMAB PLUS PEMBROLIZUMAB VERSUS PEMBROLIZUMAB ALONE IN PARTICIPANTS WITH PREVIOUSLY UNTREATED BRAF V600E-MUTANT, MSI H/DMMR METASTATIC COLORECTAL CANCER

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Study snapshot

Title
Pfizer C4221011 (Colon, BRAF, MSI)
Malignancy
Colon cancer, rectal cancer, colorectal cancer
Stage
Stage 4
Disease setting
Metastatic/Palliative
Line of therapy
1st Line
Investigational agent
encorafenib, cetuximab, pembrolizumab
Drug class
BRAF inhibitor, EGFR mAb, PD-1 inhibitor
Principal investigator
Brad Somer, MD
Sponsor
Pfizer
Path
BRAF V600 mutant, MSI-h, dMMR
Randomized
Yes
ClinicalTrials.gov ID
NCT05217446

Eligibility and objectives

Key eligibility criteria details

  • Locally confirmed microsatellite instability-high/ deficient mismatch repair (MSI-H/dMMR) stage IV colorectal carcinoma
  • Locally confirmed BRAF V600E mutation in tumor tissue or blood
  • ECOG PS 0 or 1
  • Have not received prior systemic regimens for metastatic disease.
  • Measurable disease
  • RAS wt
  • No known active central nervous system metastases and/or carcinomatous meningitis; leptomeningeal disease
  • No immunodeficiency or active autoimmune disease requiring systemic treatment in the past 2 years
  • No presence of acute or chronic pancreatitis
  • No previous treatment with any selective BRAF inhibitor (eg, encorafenib, dabrafenib, vemurafenib, XL281/BMS-908662) or any epidermal growth factor receptor (EGFR) inhibitor (eg, cetuximab, panitumumab).
  • No previous treatment with an immune checkpoint inhibitor (eg, anti-programmed cell death [PD-1], anti-PD-L1 or anti-PD-L2 agent); or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).

Objective

  • Primary
    • PFS
  • Secondary
    • Safety
    • OS
    • ORR

Treatment details