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

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.

Conditions

• 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

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood and tissue sample collection

PROCEDURE

Bone Scan

Undergo bone scan

DRUG

Cabozantinib S-malate

Given PO

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Echocardiography Test

Undergo ECHO

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Nivolumab

Given IV

DRUG

Placebo Administration

Given PO

PROCEDURE

Positron Emission Tomography

Undergo PET

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Alexander N Shoushtari · Alliance for Clinical Trials in Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-08-11

Primary Completion

2026-09-01

Completion

2026-09-01

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations