Testing the Addition of Nivolumab to Standard Treatment for Patients with Metastatic or Unresectable Colorectal Cancer with a BRAF Mutation

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05308446

Provider View

This study is exploring whether adding the drug nivolumab to the usual treatment can better shrink tumors in patients with colorectal cancer that has spread or cannot be removed by surgery and has a specific BRAF mutation.

Patient Parameters

Program Overview

This phase II clinical trial is investigating if adding nivolumab to the standard treatment of encorafenib and cetuximab is more effective in shrinking tumors for patients with colorectal cancer that has spread (metastatic) or cannot be removed by surgery (unresectable) and has a BRAF mutation. Encorafenib blocks the action of the mutated BRAF gene, slowing cancer growth. Cetuximab targets a protein on cancer cells to stop them from growing. Nivolumab is an immunotherapy that helps the immune system attack cancer. The study aims to see if this combination is more effective than the usual treatment alone.

Description

The main goal of this study is to compare how long patients live without their cancer getting worse when treated with nivolumab, encorafenib, and cetuximab versus just encorafenib and cetuximab. Other goals include comparing the overall response rate, overall survival, duration of response, and safety between the two treatment groups. The study will also collect tissue and blood samples for future research.

Participants are randomly assigned to one of two groups:

  • Group 1: Receives encorafenib daily, cetuximab every two weeks, and nivolumab every four weeks.
  • Group 2: Receives encorafenib daily and cetuximab every two weeks.

Treatment cycles repeat every 28 days unless the disease progresses or side effects become unacceptable. After treatment, participants are followed for up to three years or until death.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with colorectal cancer that has spread or cannot be removed by surgery.
  • Cancer must have a specific BRAF mutation.
  • Must have measurable disease based on scans done within the last 28 days.
  • Must have stable brain metastases if present, treated at least 28 days before joining the study.
  • Must have had one or two prior chemotherapy treatments for advanced cancer.
  • Must be 18 years or older.
  • Must have good overall health and organ function based on specific medical tests.
  • Must be able to swallow pills.
  • Must agree to provide tissue and blood samples for research.
  • Must understand and agree to the study's requirements and sign a consent form.

Exclusion Criteria

  • Cannot have HIV due to potential drug interactions.
  • Cannot have had previous treatment with certain cancer drugs targeting BRAF, MEK, or immune checkpoints.
  • Cannot be on high-dose steroids or other immunosuppressive drugs.
  • Cannot have received a live vaccine within 30 days before joining the study.
  • Cannot have gastrointestinal issues that affect drug absorption.
  • Cannot have certain autoimmune diseases or a history of severe allergic reactions to similar treatments.
  • Cannot have uncontrolled high blood pressure or recent heart issues.
  • Cannot be pregnant or nursing and must agree to use effective contraception if of reproductive potential.
  • Cannot be planning other cancer treatments not part of the study.

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