Study on Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma from Returning After Surgery
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT05111574
This clinical trial is exploring whether the drug nivolumab, alone or combined with cabozantinib, can help prevent mucosal melanoma from coming back after surgery. Nivolumab is an immunotherapy that helps the immune system fight cancer, while cabozantinib blocks proteins that help cancer cells grow.
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Program Overview
This phase II study is testing if nivolumab, with or without cabozantinib, can prevent mucosal melanoma from returning after surgery. Nivolumab is an immunotherapy that helps the immune system attack cancer cells, and cabozantinib blocks proteins that help cancer cells grow and spread. The study aims to see if this combination can stop the cancer from coming back.
Description
The main goal of this study is to compare how well nivolumab alone works against nivolumab combined with cabozantinib in preventing the return of mucosal melanoma after surgery. Patients whose cancer has been completely removed by surgery will be randomly assigned to receive either nivolumab alone or nivolumab with cabozantinib. Those whose cancer has not been fully removed or has spread will receive both drugs.
In Arm 1, patients receive nivolumab through an IV and cabozantinib as a pill every day for up to 13 cycles, each lasting 28 days, unless the cancer progresses or side effects become too severe.
In Arm 2, patients receive nivolumab through an IV and a placebo pill every day for up to 13 cycles, each lasting 28 days, unless the cancer progresses or side effects become too severe.
In Arm 3, patients receive nivolumab through an IV and cabozantinib as a pill every day for up to 26 cycles, each lasting 28 days, unless the cancer progresses or side effects become too severe.
Patients will have heart tests and may have scans like CT, MRI, or PET/CT to monitor their health. They may also provide blood, tissue, and stool samples for research. After treatment, patients will have follow-up visits every 3 months until the cancer progresses, and then every 6 months for up to 5 years or until they pass away.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of mucosal melanoma.
- Must submit tumor tissue for PD-L1 testing.
- Must have results from PD-L1 testing.
- Cancer must be fully or partially removed by surgery, or be in a state that can be measured by scans or physical exams.
- No previous treatment with checkpoint inhibitors for mucosal melanoma.
- Must not have any other active cancer that requires treatment.
- Must have completed any radiation therapy at least 28 days before starting the study.
- Must not be pregnant or nursing, and women of childbearing potential must have a negative pregnancy test.
- Must be 18 years or older.
- Must have a good performance status, meaning they can carry out daily activities with little or no assistance.
- Must have adequate blood cell counts and organ function as determined by specific tests.
- Must not have certain heart conditions or high blood pressure that is not controlled.
- Must not have any bleeding disorders or recent significant bleeding events.
- Must not have any active infections requiring treatment.
- Must not have any conditions affecting the absorption of oral medications.
- Must not have any active autoimmune diseases requiring treatment.
- Must not have any history of severe allergic reactions to study drugs.
- Must not have any untreated or unstable brain or spinal cord conditions.
- Must not be taking certain medications that interact with the study drugs.
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