Study on Binimetinib and Nivolumab for Treating Advanced Melanoma Without BRAF V600 Mutation
Sponsor: Jonsson Comprehensive Cancer Center
ClinicalTrials ID:NCT04375527
This clinical trial is testing a combination of two drugs, binimetinib and nivolumab, to see if they can effectively treat melanoma that has spread and cannot be removed by surgery, or has spread to other parts of the body. The study aims to find out if this combination works better than nivolumab alone.
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Program Overview
This study is exploring how well the drugs binimetinib and nivolumab work together to treat melanoma that has spread to nearby tissues or lymph nodes and cannot be surgically removed, or has spread to other parts of the body. Binimetinib may help stop tumor growth by blocking certain enzymes, while nivolumab, an immunotherapy drug, may help the immune system attack cancer cells. The study will compare the effectiveness of using both drugs together versus using nivolumab alone.
Description
The main goal of this study is to see how many patients experience a reduction in tumor size or complete disappearance of the tumor when treated with binimetinib and nivolumab. Researchers will also look at how long patients live without the cancer getting worse, the overall survival rate, and how long the response to treatment lasts.
Patients will take binimetinib by mouth twice a day and receive nivolumab through an IV once every four weeks. This treatment cycle will repeat for up to 12 cycles unless the cancer progresses or side effects become too severe.
After finishing the treatment, patients will have follow-up visits every three months for a year, and then once a year after that.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a good performance status, meaning they are fully active or have some restrictions but can still do light work.
- Have a confirmed diagnosis of advanced melanoma that cannot be removed by surgery or has spread.
- Have measurable disease based on imaging scans or visible lesions that can be documented.
- Must have previously tried and not responded to certain immunotherapies.
- Have a specific type of melanoma without the BRAF V600 mutation.
- Meet specific blood count and organ function requirements.
- Be willing to provide blood and tissue samples for research.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for five months after.
- Men must agree to use contraception or abstain from sex during the study and for five months after.
Exclusion Criteria
- Cannot have conditions that prevent safe tumor biopsy.
- Cannot be pregnant or breastfeeding.
- Cannot have previously used a MEK inhibitor.
- Cannot have allergies to the study drugs.
- Cannot have difficulty swallowing pills.
- Cannot have had certain cancer treatments recently.
- Cannot have had major surgery or radiation therapy recently without recovery.
- Cannot have uncontrolled brain metastases or certain autoimmune diseases.
- Cannot have significant heart disease or recent heart attacks.
- Cannot have a history of severe allergic reactions to similar drugs.
- Cannot have other active cancers or certain medical conditions that interfere with the study.
- Cannot be in another clinical trial unless it's observational.
- Cannot have certain lung diseases or gastrointestinal issues that affect drug absorption.
- Cannot have certain eye conditions or be prisoners.
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