Binimetinib and Nivolumab for the Treatment of Locally Advanced Unresectable or Metastatic BRAF V600 Wildtype Melanoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT04375527
Phase
PHASE2
Status
Terminated

Conditions

  • Clinical Stage III Cutaneous Melanoma AJCC V8
  • Clinical Stage IV Cutaneous Melanoma AJCC V8
  • Locally Advanced Cutaneous Melanoma
  • Metastatic Cutaneous Melanoma
  • Pathologic Stage III Cutaneous Melanoma AJCC V8
  • Pathologic Stage IIIA Cutaneous Melanoma AJCC V8
  • Pathologic Stage IIIB Cutaneous Melanoma AJCC V8
  • Pathologic Stage IIIC Cutaneous Melanoma AJCC V8
  • Pathologic Stage IIID Cutaneous Melanoma AJCC V8
  • Pathologic Stage IV Cutaneous Melanoma AJCC V8
  • Unresectable Cutaneous Melanoma

Eligibility Criteria

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

Interventions

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

Study Details

This phase II trial studies how well binimetinib and nivolumab work in treating patients with BRAF V600 wildtype melanoma that has spread to nearby tissues or lymph nodes and cannot be removed by surgery (locally advanced unresectable) or has spread to other places in the body (metastatic). 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 binimetinib and nivolumab together may work better in treating patients with melanoma compared to nivolumab alone.

Key Dates

Start date
Dec 3, 2020
Status verified
Nov 2024
Primary completion
Nov 22, 2024
Completion
Nov 22, 2024

Study Design

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

Arms

  • Experimental: Treatment (binimetinib, nivolumab)
    Patients receive binimetinib PO BID on days 1-28 and nivolumab IV over 30 minutes on day 1. Treatment repeats every 4 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Objective response rate [ Time Frame: Up to 26 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California at Los AngelesLos AngelesCalifornia90095-

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By research site
University of California at Los Angeles· Los Angeles, CA

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