Study on Encorafenib, Cetuximab, and Nivolumab for Treating Unremovable or Spread Colorectal Cancer with a Specific Gene Mutation

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04017650

Provider View

This clinical trial is testing a combination of three drugs—Encorafenib, Cetuximab, and Nivolumab—to see if they can effectively treat colorectal cancer that cannot be surgically removed or has spread, and has a specific gene mutation called BRAFV600E.

Patient Parameters

Program Overview

The purpose of this study is to find the best dose and understand the side effects of a combination of drugs—Encorafenib, Cetuximab, and Nivolumab—in treating colorectal cancer that cannot be removed by surgery or has spread to other parts of the body. This type of cancer has a specific gene mutation called BRAFV600E and is microsatellite stable. Encorafenib and Cetuximab may help stop tumor growth by blocking certain enzymes, while Nivolumab, an immunotherapy drug, may help the immune system attack the cancer. The study aims to see if this combination works better than using Cetuximab alone.

Description

The main goals of this study are to see how well the combination of Encorafenib, Cetuximab, and Nivolumab works in shrinking tumors and to understand the safety and side effects of these drugs when used together. Researchers will also look at how long patients live without the cancer getting worse and how long they live overall. They will also study how quickly the cancer responds to the treatment and how long the response lasts.

The study will also explore changes in the cancer's genetic and immune characteristics and test the feasibility of creating patient-derived models for further research.

This study has two phases: Phase I will determine the best dose, and Phase II will further evaluate the treatment's effectiveness. Patients will take Encorafenib by mouth daily, receive Cetuximab through an IV on specific days, and get Nivolumab through an IV on the first day of each cycle. Each cycle lasts 28 days, and treatment continues unless the cancer progresses or side effects become unacceptable. After treatment, patients will have follow-up visits at 30 and 100 days, then every three months.

Eligibility Criteria

Inclusion Criteria

  • Must provide signed consent to participate, with a translator available if needed.
  • Must be 18 years or older.
  • Must have a confirmed diagnosis of colorectal cancer that cannot be removed by surgery or has spread, and is measurable by standard criteria.
  • Must have a specific gene mutation (BRAFV600E) and be microsatellite stable, confirmed by a certified lab.
  • For certain groups, must have had one or two prior chemotherapy treatments for metastatic colorectal cancer or have had cancer return within six months of previous treatment.
  • Must have good overall health with a performance status of less than 1.
  • Must have adequate blood counts and organ function as shown by specific lab tests.
  • Must be able to take oral medications.
  • Women must not be pregnant and must agree to use effective birth control during and after the study. Men must also agree to use birth control to prevent fathering a child during and after the study.

Exclusion Criteria

  • Cannot be on corticosteroid therapy or other immunosuppressive medications, except for certain low-dose steroids.
  • Cannot have had certain prior treatments, including specific inhibitors or immune checkpoint therapies.
  • Cannot have had a tissue or organ transplant.
  • Cannot have a history of certain lung conditions requiring steroids.
  • Cannot have received a live vaccine within 30 days before starting the study.
  • Cannot have had severe allergic reactions to similar treatments.
  • Cannot have active infections requiring antibiotics.
  • Cannot have untreated or symptomatic brain metastases.
  • Cannot have had another cancer within the last three years, with some exceptions.
  • Cannot have significant heart or blood pressure issues.
  • Cannot have certain viral infections like HIV or active hepatitis.
  • Cannot have a history of certain autoimmune or gastrointestinal diseases.
  • Cannot have had major surgery within six weeks before starting the study.
  • Cannot be pregnant or nursing.
  • Must not have any condition that would interfere with understanding the study or following the protocol.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.