Testing BRAF-Targeted Therapy After Surgery and Usual Chemotherapy for BRAF-Mutated Colon Cancer

Sponsor: Alliance for Clinical Trials in Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05710406

Provider View

This clinical trial is exploring whether adding the drugs encorafenib and cetuximab after surgery and standard chemotherapy can better prevent the return of BRAF-mutated colon cancer compared to just monitoring the patient.

Patient Parameters

Program Overview

This study is investigating if using the drugs encorafenib and cetuximab after surgery and usual chemotherapy can reduce the chance of colon cancer coming back in patients with a specific BRAF mutation. Encorafenib works by blocking certain enzymes that help cancer cells grow, while cetuximab is a type of medication that attaches to a protein on cancer cells to stop them from growing. The trial compares this treatment to the usual approach of just observing patients after their initial treatment.

Description

The study has several goals:

Primary Goals:

  • To see if the new treatment can clear cancer-related DNA from the blood within 6 months in patients who had detectable levels before starting the trial.
  • To compare how long patients remain free of cancer when treated with the new drugs versus usual care.

Secondary Goals:

  • To compare overall survival rates between the two groups.
  • To assess the side effects of the new treatment compared to usual care.
  • To evaluate how long patients stay cancer-free from the time of their initial surgery.
  • To look at patient-reported symptoms like rash, diarrhea, and fatigue.

Study Design:

  • Participants are randomly assigned to one of two groups.
  • Group 1: Receives encorafenib orally and cetuximab through an IV, along with regular blood tests and scans.
  • Group 2: Undergoes regular monitoring with blood tests and scans, without additional treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed BRAF V600 mutation in their colon cancer.
  • Cancer must be stage III or high-risk stage II and have been completely removed by surgery.
  • Must have received at least 3 months of standard chemotherapy.
  • Must be 18 years or older.
  • Must have good overall health and specific blood counts and organ function.
  • Women must not be pregnant and must agree to use birth control.
  • Must not have any other active cancers, except for certain non-threatening types.
  • Must not have any medical conditions that would make the study treatment unsafe.
  • Must not have allergies to similar drugs as cetuximab.
  • Must not be taking certain medications that could interfere with the study drugs.

Exclusion Criteria

N/A

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