A Randomized Phase II Trial of Adjuvant Nivolumab With or Without Cabozantinib in Patients With Resected Mucosal Melanoma
National Cancer Institute (NCI)
Summary
This phase II trial tests whether nivolumab in combination with cabozantinib works in patients with mucosal melanoma. 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. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps stop the spread of tumor cells. Giving nivolumab in combination with cabozantinib could prevent cancer from returning.
Description
PRIMARY OBJECTIVE: I. To compare the efficacy of adjuvant nivolumab (480 mg every \[q\]4 weeks) versus nivolumab plus cabozantinib s-malate (cabozantinib) (40 mg daily) in patients with mucosal melanoma. SECONDARY OBJECTIVES: I. To compare overall survival between the two adjuvant therapies. II. To evaluate the adverse effects in each arm. III. To assess the correlation between PD-L1 expression in tumor cells with survival (recurrence free survival \[RFS\] and overall survival \[OS\]). IV. To evaluate the overall response rate (ORR), duration of response (DOR), progression free survival (P…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * STEP 0 INCLUSION CRITERIA * Histologically proven mucosal melanoma by local pathology * Central PD-L1 tumor tissue submission * STEP 1 INCLUSION CRITERIA * Receipt of the central PD-L1 testing results available * Report is required for randomization of resection R0 or R1 patients * Testing must be started in Step 0 but results can be reported after registration for resection R2 patients * Disease status-Resected R0 or R1 disease patients. Patients eligible for randomization have resected R0 or R1 disease (with negative margins or positive microscopic margins) that m…
Interventions
- ProcedureBiospecimen Collection
Undergo blood and tissue sample collection
- ProcedureBone Scan
Undergo bone scan
- DrugCabozantinib S-malate
Given PO
- ProcedureComputed Tomography
Undergo CT
- ProcedureEchocardiography Test
Undergo ECHO
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- BiologicalNivolumab
Given IV
Locations (147)
- Sutter Auburn Faith HospitalAuburn, California
- Alta Bates Summit Medical Center-Herrick CampusBerkeley, California
- Palo Alto Medical Foundation-FremontFremont, California
- Keck Medicine of USC KoreatownLos Angeles, California
- Los Angeles General Medical CenterLos Angeles, California
- USC / Norris Comprehensive Cancer CenterLos Angeles, California