Encorafenib, Cetuximab, and Nivolumab in Treating Patients With Microsatellite Stable, BRAFV600E Mutated Unresectable or Metastatic Colorectal Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT04017650
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • BRAF NP_004324.2:p.V600E
  • Metastatic Colon Adenocarcinoma
  • Metastatic Microsatellite Stable Colorectal Carcinoma
  • Metastatic Rectal Adenocarcinoma
  • Progressive Disease
  • Recurrent Colorectal Carcinoma
  • Stage III Colorectal Cancer AJCC v8
  • Stage IIIA Colorectal Cancer AJCC v8
  • Stage IIIB Colorectal Cancer AJCC v8
  • Stage IIIC Colorectal Cancer AJCC v8
  • Stage IV Colorectal Cancer AJCC v8
  • Stage IVA Colorectal Cancer AJCC v8
  • Stage IVB Colorectal Cancer AJCC v8
  • Stage IVC Colorectal Cancer AJCC v8
  • Unresectable Colon Adenocarcinoma
  • Unresectable Rectal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

This phase I/II trial studies the best dose and side effects of encorafenib, cetuximab, and nivolumab and how well they work together in treating patients with microsatellite stable, BRAFV600E gene mutated colorectal cancer that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Encorafenib and cetuximab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 encorafenib, cetuximab, and nivolumab may work better in treating patients with colorectal cancer compared to cetuximab alone.

Key Dates

Start date
Jun 14, 2019
Status verified
Jun 2026
Primary completion
Dec 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (encorafenib, cetuximab, nivolumab)
    Patients receive encorafenib PO QD on days 1-28, cetuximab IV over 1 hour on days 1 and 15, and nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Best radiographic response [ Time Frame: Within 6 months of initiation of study treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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By research site
M D Anderson Cancer Center· Houston, TX

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