Study on Encorafenib and Cetuximab with Pembrolizumab Compared to Pembrolizumab Alone for Untreated Metastatic Colorectal Cancer

Sponsor: Pfizer

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05217446

Provider View

This clinical trial is exploring the effects of combining three medications—encorafenib, cetuximab, and pembrolizumab—versus using pembrolizumab alone in treating colorectal cancer that has spread to other parts of the body and has specific genetic characteristics.

Patient Parameters

Program Overview

The aim of this study is to understand how well a combination of three medications—encorafenib, cetuximab, and pembrolizumab—works in treating colorectal cancer that has spread to other parts of the body, has a genetic tendency to mutate, and has a specific abnormal gene called BRAF. Participants in this study have not received any prior treatment for their cancer. All participants will receive pembrolizumab through an IV infusion at the study clinic. Additionally, half of the participants will take encorafenib orally at home every day and receive cetuximab through an IV infusion at the clinic. The study team will regularly check on participants to see how they are responding to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have stage IV colorectal cancer with specific genetic characteristics, confirmed by local tests.
  • Have a BRAF V600E mutation in the tumor or blood.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have not received any previous treatments for metastatic cancer.
  • Have measurable cancer according to standard criteria.
  • Have adequate organ function as determined by specific medical tests.

Exclusion Criteria

  • Have colorectal cancer with a RAS mutation or unknown RAS mutation status.
  • Have active cancer spread to the brain or spinal cord, or specific types of brain cancer.
  • Have an immune system deficiency or active autoimmune disease requiring treatment in the past two years.
  • Have acute or chronic pancreatitis.
  • Have significant heart diseases, such as recent heart attacks or strokes.
  • Have received a live vaccine within 30 days before starting the study medication.
  • Have previously been treated with any selective BRAF or EGFR inhibitors.
  • Have previously been treated with immune checkpoint inhibitors or other specific immune therapies.

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