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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood and tissue sample collection
• Bone Scan — PROCEDURE
  Undergo bone scan
• Cabozantinib S-malate — DRUG
  Given PO
• Computed Tomography — PROCEDURE
  Undergo CT
• Echocardiography Test — PROCEDURE
  Undergo ECHO
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Nivolumab — BIOLOGICAL
  Given IV
• Placebo Administration — DRUG
  Given PO
• Positron Emission Tomography — PROCEDURE
  Undergo PET

Study Details

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 Dates

Start date

Aug 11, 2022

Status verified

Jun 2026

Primary completion

Sep 1, 2026

Completion

Sep 1, 2026

Study Design

Enrollment

101 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1 (nivolumab, cabozantinib)
  Patients receive nivolumab IV over 30 minutes on day 1 and cabozantinib PO QD of each cycle. Treatment repeats every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO during screening and as clinically indicated throughout the trial. Patients may undergo CT, MRI, or PET/CT at baseline, CT and MRI may be repeated every 6 months on study. Additionally, patients may undergo bone scans, as well as optional blood and tissue sample collection throughout the trial.
• Active Comparator: Arm 2 (nivolumab, placebo)
  Patients receive nivolumab IV over 30 minutes on day 1 and placebo PO QD of each cycle. Treatment repeats every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO during screening and as clinically indicated throughout the trial. Patients may undergo CT, MRI, or PET/CT at baseline, CT and MRI may be repeated every 6 months on study. Additionally, patients may undergo bone scans, as well as optional blood and tissue sample collection throughout the trial.
• Experimental: Arm 3 (nivolumab, cabozantinib)
  Patients receive nivolumab IV over 30 minutes and cabozantinib PO QD of each cycle. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO during screening and as clinically indicated throughout the trial. Patients may undergo CT, MRI, or PET/CT at baseline, CT and MRI may be repeated every 6 months on study. Additionally, patients may undergo bone scans, as well as optional blood and tissue sample collection throughout the trial.

Primary Outcome Measure

Recurrence free survival (RFS) [ Time Frame: Number of days from registration until either local or distant recurrence or death (due to any cause), assessed up to 5 years ]

Locations (143)

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