Randomized Phase II Trial of Encorafenib and Cetuximab With or Without Nivolumab (NSC #748726) for Patients With Previously Treated, Microsatellite Stable, BRAFV600E Metastatic and/or Unresectable Colorectal Cancer

Official Summary

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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 84 participants

Interventions

• BIOLOGICAL: Cetuximab — Given IV
• DRUG: Encorafenib — Given PO
• BIOLOGICAL: Nivolumab — Given IV

Primary Outcomes

• Progression-free survival (PFS) (From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years)

Secondary Outcomes

• Overall response rate (ORR) (Up to 3 years)
• Overall survival (OS) (From date of registration to date of death due to any cause, assessed up to 3 years)
• Duration of response (DoR) (From date of first documentation of confirmed response (complete response or partial response) to date of first documentation of progression or symptomatic deterioration or death due to any cause among participants who achieve a response, up to 3 years)
• Immune related progression-free survival (irRC-PFS) in Arm I (From date of registration to date of initial documentation of irRC-progression that has subsequently been confirmed or symptomatic deterioration, or death due to any cause, assessed up to 3 years)
• Incidence of adverse events (Up to 3 years)

Trial Locations

• CTCA at Western Regional Medical Center, Goodyear, Arizona, United States
• Mercy Cancer Center - Carmichael, Carmichael, California, United States
• Mercy San Juan Medical Center, Carmichael, California, United States
• Kaiser Permanente Dublin, Dublin, California, United States
• Mercy Cancer Center - Elk Grove, Elk Grove, California, United States
• Kaiser Permanente-Fremont, Fremont, California, United States
• Kaiser Permanente-Fresno, Fresno, California, United States
• UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care, Irvine, California, United States
• Kaiser Permanente-Modesto, Modesto, California, United States
• Kaiser Permanente-Oakland, Oakland, California, United States
• ...and 10 more locations

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