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Binimetinib and Nivolumab for the Treatment of Locally Advanced Unresectable or Metastatic BRAF V600 Wildtype Melanoma | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

A Phase 2 Study of Combination Treatment of Binimetinib and Nivolumab for Advanced V600BRAF Wildtype Melanoma with Innate Anti-PD-1 Resistance

NCT04375527•Jonsson Comprehensive Cancer Center

View on ClinicalTrials.gov

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.

Detailed Description

PRIMARY OBJECTIVE: I. Objective response rate (ORR), which is defined as the proportion of response-evaluable participants either with a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as determined by the investigator assessment, at best overall response. SECONDARY OBJECTIVE: I. Progression-free survival (PFS), clinical benefit rate (CR + PR + stable disease \[SD\] among response-evaluable participants, per RECIST 1.1), overall survival (OS) and duration of response (DOR). EXPLORATORY OBJECTIVE: I. Evaluation of histologic evidence of response (p-ERK reduction in residual tumor cells and CD8 T cell or tumor infiltrating lymphocytes or tumor infiltrating lymphocyte \[TIL\] infiltration induced by combination treatment) using pretreatment and early on-treatment tumor biopsies. OUTLINE: Patients receive binimetinib orally (PO) twice daily (BID) on days 1-28 and nivolumab intravenously (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. After completion of study treatment, patients are followed up every 3 months for up to 1 year, then annually thereafter.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males or females age \>= 18 years
•Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
•Histologically confirmed locally advanced/unresectable or metastatic cutaneous melanoma
•Measurable disease per RECIST version (v.) 1.1 criteria using imaging scans, OR peripheral lesions that can be adequately documented with a picture and a ruler even if they do not meet RECIST criteria
•Patient must have failed prior alphaPD-1 or alphaPD-1 + alphaCTLA-4 therapy in the metastatic setting
•V600BRAF wildtype tumor status confirmed by Clinical Laboratory Improvement Act (CLIA) approved lab
•Hemoglobin \>= 8.0 g/dL
•Whole blood cell count (WBC) \>= 2,000/mm\^3
•Absolute neutrophil count \>= 1,500/mm\^3
•Platelet count \>= 75,000/mm\^3
+10 more criteria

Exclusion Criteria

•Contraindications to tumor biopsy (coagulopathy, known history of keloid formation, etc.)
•Women who are pregnant or breastfeeding
•Prior therapy with a MEK inhibitor (e.g., binimetinib, trametinib, cobimetinib)
•Known hypersensitivity or contraindication to any component of binimetinib or its excipients
•Inability to swallow and retain study drug
•Patients who have received prior lines of systemic therapy in the advanced/metastatic setting (not including, neoadjuvant, adjuvant, or maintenance therapy)
•Received anticancer therapy including chemotherapy, immunotherapy, or antineoplastic biologic therapy (e.g., erlotinib, cetuximab, bevacizumab etc.), within 14 days prior to start of study treatment or exposure to any investigational drug within 7 days prior to screening visit or for which 5 half-lives have not elapsed
•Participants who have undergone major surgery (e.g., in-patient procedures) =\< 6 weeks prior to start of study treatment or who have not recovered from side effects of such procedure
•Participants who have had radiotherapy =\< 14 days prior to start of study treatment or who have not recovered from side effects of such procedure. Note: Palliative radiation therapy must be complete 7 days prior to the first dose of study treatment
•Participants who have not recovered to =\< grade 1 from toxic effects of prior therapy before starting study treatment
+31 more criteria

Locations (1)

University of California at Los Angeles

Los Angeles, California, United States

Key Dates

Start Date

December 3, 2020

Primary Completion Date

November 22, 2024

Completion Date

November 22, 2024

Last Updated

December 4, 2024

Enrollment

ACTUAL participants

Conditions

Clinical Stage III Cutaneous Melanoma AJCC V8Clinical Stage IV Cutaneous Melanoma AJCC V8Locally Advanced Cutaneous MelanomaMetastatic Cutaneous MelanomaPathologic Stage III Cutaneous Melanoma AJCC V8Pathologic Stage IIIA Cutaneous Melanoma AJCC V8Pathologic Stage IIIB Cutaneous Melanoma AJCC V8Pathologic Stage IIIC Cutaneous Melanoma AJCC V8Pathologic Stage IIID Cutaneous Melanoma AJCC V8Pathologic Stage IV Cutaneous Melanoma AJCC V8Unresectable Cutaneous Melanoma

Interventions

Binimetinib

DRUG

Nivolumab

BIOLOGICAL

Questionnaire Administration

OTHER

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RECRUITINGNA

Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer

NCT06391099

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 4, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer

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