Nivolumab + Standard Treatment for Colorectal Cancer

Recruiting at 328 trial locations

Overseen By Deepak Vadehra

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial tests whether adding nivolumab to the usual treatment (encorafenib and cetuximab) works better than the usual treatment alone to shrink tumors in patients with colorectal cancer that has spread to other places in the body (metastatic) or that cannot be removed by surgery (unresectable) and whose tumor has a mutation in a gene called BRAF. Encorafenib is in a class of medications called kinase inhibitors. It is used in patients whose cancer has a certain mutation (change) in the BRAF gene. It works by blocking the action of mutated BRAF that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab in combination with encorafenib and cetuximab may be more effective than encorafenib and cetuximab alone at stopping tumor growth and spreading in patients with metastatic or unresectable BRAF-mutant colorectal cancer.

Research Team

Van K Morris

Principal Investigator

SWOG Cancer Research Network

Eligibility Criteria

This trial is for adults with metastatic or unresectable colorectal cancer that has a BRAF mutation. They should have had one or two prior chemotherapy treatments, no severe heart conditions, and be able to swallow pills. Excluded are those with recent heart issues, uncontrolled hypertension, active infections like HIV, certain immune diseases, or who've had specific past treatments like anti-EGFR therapies.

Inclusion Criteria

I have chronic hepatitis B but it's under control with medication.

My scans show cancer that cannot be removed or has spread.

Participants must be informed of the investigational nature of the study and provide informed consent

Exclusion Criteria

Participants must not be pregnant or nursing and must agree to use effective contraception

I have not had any major heart problems recently.

Participants must not be receiving any other investigational agents

Treatment Details

Interventions

• Cetuximab (Monoclonal Antibodies)
• Encorafenib (Kinase Inhibitor)
• Nivolumab (Monoclonal Antibodies)

Trial Overview The study tests if adding Nivolumab (an immunotherapy drug) to the standard treatment of Encorafenib and Cetuximab improves outcomes in patients. It's a phase II trial aiming to see if this combination better shrinks tumors compared to the usual treatment alone.

Participant Groups

Group I: Arm I (encorafenib, cetuximab, nivolumab) Experimental Treatment 3 Interventions

Patients receive encorafenib PO QD on days 1-28, cetuximab IV on days 1 and 15, and nivolumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (encorafenib, cetuximab) Active Control 2 Interventions

Patients receive encorafenib PO QD on days 1-28 and cetuximab IV on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+