NCT05111574

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

Recruiting now Phase 2 Last updated 13 April 2026

What this trial tests

Phase 2 trial testing Biospecimen Collection in Anal Melanoma in 101 participants. Currently enrolling.

Timeline

11 August 2022

Primary endpoint
1 September 2026

1 September 2026

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	101
Start date	11 August 2022
Primary completion	1 September 2026
Estimated completion	1 September 2026
Sites	147 locations across Canada, United States

Drugs / interventions tested

• Biospecimen Collection — full drug profile →
• Bone Scan — full drug profile →
• Cabozantinib S-malate — full drug profile →
• Computed Tomography
• Echocardiography Test
• Magnetic Resonance Imaging
• Nivolumab (nivolumab) — full drug profile →
• Placebo Administration
• Positron Emission Tomography

Conditions studied

• Anal Melanoma — all drugs for Anal Melanoma →
• Bladder Melanoma — all drugs for Bladder Melanoma →
• Cervical Melanoma — all drugs for Cervical Melanoma →
• Esophageal Melanoma — all drugs for Esophageal Melanoma →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Anal Melanoma or Bladder Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dissecting the Role of AXL in Cancer Immune Escape and Resistance to Immune Checkpoint Inhibition.
   Engelsen AST, Lotsberg ML, Abou Khouzam R, Thiery JP, et al · · 2022 · cited 74× · PMID 35572601 · DOI 10.3389/fimmu.2022.869676
2. Mucosal Melanoma: Epidemiology, Clinical Features, and Treatment.
   Sergi MC, Filoni E, Triggiano G, Cazzato G, et al · · 2023 · cited 29× · PMID 37773078 · DOI 10.1007/s11912-023-01453-x
3. Trial Watch: combination of tyrosine kinase inhibitors (TKIs) and immunotherapy.
   Petrazzuolo A, Maiuri MC, Zitvogel L, Kroemer G, et al · · 2022 · cited 23× · PMID 35655707 · DOI 10.1080/2162402x.2022.2077898
4. Molecular Profiling and Novel Therapeutic Strategies for Mucosal Melanoma: A Comprehensive Review.
   Indini A, Roila F, Grossi F, Massi D, et al · · 2021 · cited 19× · PMID 35008570 · DOI 10.3390/ijms23010147
5. Shaping the Future of Immunotherapy Targets and Biomarkers in Melanoma and Non-Melanoma Cutaneous Cancers.
   Spiliopoulou P, Vornicova O, Genta S, Spreafico A. · · 2023 · cited 10× · PMID 36674809 · DOI 10.3390/ijms24021294
6. Advances in immunotherapy for mucosal melanoma: harnessing immune checkpoint inhibitors for improved treatment outcomes.
   Shan Z, Liu F. · · 2024 · cited 9× · PMID 39234260 · DOI 10.3389/fimmu.2024.1441410
7. Primary Mucosal Melanoma: Clinical Experience from a Single Italian Center.
   Falcone R, Verkhovskaia S, Di Pietro FR, Poti G, et al · · 2024 · cited 5× · PMID 38275835 · DOI 10.3390/curroncol31010042
8. Current Status and Molecular Mechanisms of Resistance to Immunotherapy in Oral Malignant Melanoma.
   Usta SZ, Uchihashi T, Kodama S, Kurioka K, et al · · 2023 · cited 5× · PMID 38139110 · DOI 10.3390/ijms242417282