West Cancer Center

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

Title

Pfizer C4221011 (Colon, BRAF, MSI)

Study Title

Site Link

NCT05217446

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

Brad Somer, MD

Sponsor

Pfizer

Phase

Phase 2

Status

Open to Enrollment

Key Eligibility Criteria

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

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

BRAF V600 mutant, MSI-h, dMMR

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes