Encorafenib, Binimetinib, and Nivolumab in Treating Microsatellite Stable BRAF V600E Metastatic Colorectal Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT04044430
Phase
PHASE1
Status
Terminated

Conditions

  • Metastatic Colon Adenocarcinoma
  • Metastatic Colorectal Adenocarcinoma
  • Metastatic Microsatellite Stable Colorectal Carcinoma
  • Metastatic Rectal Adenocarcinoma
  • Stage III Colon Cancer
  • Stage III Colorectal Cancer
  • Stage III Rectal Cancer
  • Stage IIIA Colon Cancer
  • Stage IIIA Colorectal Cancer
  • Stage IIIA Rectal Cancer
  • Stage IIIB Colon Cancer
  • Stage IIIB Colorectal Cancer
  • Stage IIIB Rectal Cancer
  • Stage IIIC Colon Cancer
  • Stage IIIC Colorectal Cancer
  • Stage IIIC Rectal Cancer
  • Stage IV Colon Cancer
  • Stage IV Colorectal Cancer
  • Stage IV Rectal Cancer
  • Stage IVA Colon Cancer
  • Stage IVA Colorectal Cancer
  • Stage IVA Rectal Cancer
  • Stage IVB Colon Cancer
  • Stage IVB Colorectal Cancer
  • Stage IVB Rectal Cancer
  • Stage IVC Colon Cancer
  • Stage IVC Colorectal Cancer
  • Stage IVC Rectal Cancer

Eligibility Criteria

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

Interventions

  • Binimetinib — DRUG
    Given PO
  • Encorafenib — DRUG
    Given PO
  • Nivolumab — BIOLOGICAL
    Given IV
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

This phase I/II trial studies the side effects and how well encorafenib, binimetinib, and nivolumab work in treating patients with microsatellite stable, BRAFV600E gene-mutated colorectal cancer that has spread to other places in the body (metastatic). Encorafenib and binimetinib 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, binimetinib, and nivolumab may work better in treating patients with colorectal cancer compared to standard treatments.

Key Dates

Start date
Aug 31, 2020
Status verified
Jan 2023
Primary completion
Jul 31, 2022
Completion
Jul 31, 2022

Study Design

Enrollment
2 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (encorafenib, binimetinib, nivolumab)
    Participants in Phase 1 receive encorafenib PO QD on days 1-28, binimetinib PO BID on days 1-28, and nivolumab IV on day 1. Cycles repeat every 28 days for a maximum of 24 cycles of treatment in the absence of disease progression or unacceptable toxicity. The study was terminated before Phase II was initiated. The study did not open Phase II for enrollment.

Primary Outcome Measure

Radiographic Response [ Time Frame: Up to 3 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Kaiser Permanente Northern CaliforniaSan FranciscoCalifornia94115-
Univeristy of California, San FranciscoSan FranciscoCalifornia94115-

Find similar trials in San Francisco, CA

By research site
Kaiser Permanente Northern California· San Francisco, CAUniveristy of California, San Francisco· San Francisco, CA

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