Study on Binimetinib and Imatinib for Advanced KIT-Mutant Melanoma That Cannot Be Removed by Surgery
Sponsor: University of California, San Francisco
ClinicalTrials ID:NCT04598009
This clinical trial is testing the effectiveness of two drugs, binimetinib and imatinib, in treating patients with advanced melanoma that has a specific mutation (KIT-mutant) and cannot be surgically removed. The study aims to see if these drugs can stop tumor growth by blocking certain enzymes needed for cell growth.
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Program Overview
This phase II study is exploring how well the combination of binimetinib and imatinib works in patients with advanced melanoma that has a KIT mutation and cannot be removed by surgery. These drugs may help stop the growth of tumor cells by blocking enzymes necessary for cell growth. The study will evaluate the response rate, safety, and effectiveness of this treatment in patients with KIT-mutant melanoma.
Description
The main goal of this study is to see how well the combination of binimetinib and imatinib works in treating advanced KIT-mutant melanoma. Researchers will look at how many patients respond to the treatment and how safe and tolerable it is. They will also study the effectiveness and survival rates of patients receiving this treatment.
The study will also explore how changes in certain proteins in the body relate to the treatment's effectiveness and whether specific genetic factors contribute to resistance to the treatment. Additionally, researchers will create models to study the relationship between clinical outcomes and various features of the melanoma, such as its subtype and previous treatments.
Participants will take binimetinib twice daily and imatinib once daily in 28-day cycles, as long as the disease does not progress or cause unacceptable side effects. After completing the treatment, patients will have follow-up visits on day 30 and day 100, and then every three months.
Eligibility Criteria
Inclusion Criteria
- Must have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
- Must have a confirmed diagnosis of melanoma that cannot be removed by surgery and is at stage III or IV.
- Must have measurable disease according to specific criteria.
- Must have a confirmed KIT mutation in the melanoma.
- Must have tried standard treatments or be unable to tolerate them.
- Must have adequate blood cell counts and organ function as determined by specific tests.
- Must not have active brain metastases that require immediate treatment.
- Women of childbearing potential must agree to use effective contraception and not donate eggs during the study.
- Men must agree to use condoms and not donate sperm during the study.
- Must be able to understand and sign a written informed consent document.
Exclusion Criteria
- Cannot have received other cancer treatments recently, including systemic therapies within 3 weeks, radiation within 2 weeks, or antibody therapy within 4 weeks.
- Must have recovered from any side effects of previous cancer treatments to a mild level.
- Cannot be taking other investigational drugs or have taken them recently.
- Must be able to swallow and retain the study drugs.
- Cannot have gastrointestinal issues that affect drug absorption.
- Cannot have allergies to binimetinib or imatinib.
- Cannot have certain heart conditions or uncontrolled high blood pressure.
- Cannot be taking medications that interfere with the study drugs.
- Cannot have had recent blood clots or strokes unless stable on treatment.
- Pregnant or breastfeeding women cannot participate due to potential risks to the baby.
- Cannot have other severe medical or psychiatric conditions that increase risk or interfere with the study.
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