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

Contact:

NCT Number:

Protocol:

AAAU2336

Study Status:

Closed to Accrual, Study Active

Population:

Adult

Phase:

II

The purpose of this study is to determine if the study drugs, encorafenib and cetuximab, taken in combination with pembrolizumab would improve compared to the outcome of pembrolizumab alone in study patients. Encorafenib and cetuximab target cancerous BRAF proteins and potentially slow down the growth of cancer cells. Pembrolizumab may help your immune system to kill cancer cells. Encorafenib is a BRAF inhibitor (a drug that can shrink or slow the growth of tumors) that is approved in several jurisdictions (including the United States [US]) in combination with cetuximab for the treatment of patients with metastatic BRAF‑mutant CRC, after prior therapy. Pembrolizumab is approved in the US for patients with mCRC with MSI-H/dMMR mutation that has not been treated.

Are you Eligible? (Inclusion Criteria)

  • You must be 18 years old or older.
  • You must be able to swallow, retain, and absorb oral medications.
  • You must have no known pancreatitis.
  • You must comply with all scheduled visits and treatment plan.

Specialty Area(s)

Principal Investigator

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032