Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Anal Melanoma, Bladder Melanoma, Cervical Melanoma, Esophageal Melanoma, Gallbladder Melanoma, Head and Neck Mucosal Melanoma, Mucosal Melanoma, Nasopharyngeal Mucosal Melanoma, Oral Cavity Mucosal Melanoma, Penile Mucosal Melanoma, Rectal Melanoma, Recurrent Mucosal Melanoma, Sinonasal Mucosal Melanoma, Urethral Melanoma, Urinary System Mucosal Melanoma, Vaginal Melanoma, Vulvar Melanoma

In brief

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.

Key facts

Study ID

NCT05111574

Run by

National Cancer Institute (NCI)

People needed

101

Starts

2022-08-11

Expected to finish

2027-07-15

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 must meet one of the following 4 criteria as defined below:
• Regional lymph node (LN) involvement; OR
• In-transit metastases/satellite primary disease; OR
• Single localized, primary disease meeting one of the following site-specific requirements:
• Head/neck - Sinonasal (including nasopharynx): any primary lesion; Nasal or oral cavity; pT4a or above, given slightly improved OS
• NOTE: Conjunctival: does not meet the qualification for eligibility
• Anorectal - any primary lesion
• Vaginal/cervical - any primary, as they have 5 year OS rates of 5-25%
• Urinary tract - any primary urethral or bladder tumor
• Penile
• Vulvar- American Joint Committee on Cancer (AJCC) cutaneous stage IIB or higher
• Esophageal/gallbladder - any primary
• Locoregionally recurrent following prior resection, meeting at least one of the above criteria
• In addition, patients must have undergone cross-sectional imaging of the brain, chest, abdomen and pelvis with no evidence of distant metastatic disease
• Disease status-Non-resected R2 or metastatic disease patients
• Non-resected R2 or metastatic disease that is assessable and measurable radiographically or by physical examination
• Prior Treatment:
• No prior systemic checkpoint inhibitor therapy of mucosal melanoma, including in the adjuvant setting, is allowed. Prior adjuvant chemotherapy or interferon is allowed.

Where it is running

• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
• Palo Alto Medical Foundation-Fremont — Fremont, California, United States
• Keck Medicine of USC Koreatown — Los Angeles, California, United States
• Los Angeles General Medical Center — Los Angeles, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Memorial Medical Center — Modesto, California, United States
• USC Norris Oncology/Hematology-Newport Beach — Newport Beach, California, United States
• Palo Alto Medical Foundation Health Care — Palo Alto, California, United States
• Stanford Cancer Institute Palo Alto — Palo Alto, California, United States
• Sutter Roseville Medical Center — Roseville, California, United States
• Sutter Medical Center Sacramento — Sacramento, California, United States
• California Pacific Medical Center-Pacific Campus — San Francisco, California, United States
• UCSF Medical Center-Mission Bay — San Francisco, California, United States
• Mills Health Center — San Mateo, California, United States
• Palo Alto Medical Foundation-Santa Cruz — Santa Cruz, California, United States
• Sutter Pacific Medical Foundation — Santa Rosa, California, United States
• Palo Alto Medical Foundation-Sunnyvale — Sunnyvale, California, United States
• Sutter Solano Medical Center/Cancer Center — Vallejo, California, United States
• The Melanoma and Skin Cancer Institute — Englewood, Colorado, United States
• UM Sylvester Comprehensive Cancer Center at Aventura — Aventura, Florida, United States
• UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables, Florida, United States
• UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach, Florida, United States
• University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States
• UM Sylvester Comprehensive Cancer Center at Plantation — Plantation, Florida, United States
• Sutter Auburn Faith Hospital — Auburn, California, United States

Full record on ClinicalTrials.gov

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