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

NCT04375527 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-12-04

No results posted yet for this study

Summary

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.

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

Interventions

DRUG

Binimetinib

Given PO

BIOLOGICAL

Nivolumab

Given IV

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • Array BioPharma

    collaborator INDUSTRY

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Jonsson Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Roger Lo, MD · UCLA / Jonsson Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-03
Primary Completion
2024-11-22
Completion
2024-11-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04375527 on ClinicalTrials.gov