BRAF V600E-mutant and MSI-H Metastatic Colorectal Cancer Study of Encorafenib Taken With Cetuximab Plus Pembrolizumab Compared to Pembrolizumab Alone

• Status: Not yet recruiting
• Trial end date: 2027-02-10
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate whether encorafenib plus cetuximab with pembrolizumab can improve outcomes compared to pembrolizumab alone in previously untreated participants with microsatellite instability-high/ deficient mismatch repair (MSI-H/dMMR) and B-Raf proto-oncogene (BRAF V600E) mutant metastatic colorectal cancer (CRC)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Collaborators: Eli Lilly and Company; Merck KGaA, Darmstadt, Germany; Merck Sharp & Dohme Corp.
• Treatments: Cetuximab; Pembrolizumab

Criteria

Inclusion Criteria:

• 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

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Have not received prior systemic regimens for metastatic disease.

• Measurable disease per RECIST 1.1

• Adequate organ function

Exclusion Criteria:

• Colorectal adenocarcinoma that is RAS mutant or for which RAS mutation status is unknown

• Known active central nervous system metastases and/or carcinomatous meningitis; leptomeningeal disease

• Immunodeficiency or active autoimmune disease requiring systemic treatment in the past 2 years

• Presence of acute or chronic pancreatitis

• Clinically significant cardiovascular diseases (eg, thromboembolic or cerebrovascular accident events ≤ 12 wks prior)

• Received a live or live-attenuated vaccine within 30 days of planned start of study medication

• 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).

• 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).