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NCT05111574 · ClinicalTrials.gov registry record · Phase 2
Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery
A Phase 2 study of Mucosal Melanoma and Anal Melanoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 101
- Enrollment target
- 20
- Study locations
NCT05111574: Recruiting Phase 2 study of Mucosal Melanoma and Anal Melanoma, sponsored by National Cancer Institute (NCI).
NCT05111574 is a Phase 2 study of Mucosal Melanoma and Anal Melanoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 101 participants, below the 146-participant average among 12 other Mucosal Melanoma trials with a reported enrollment target (31% lower). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05111574, a Phase 2 study of Mucosal Melanoma and Anal Melanoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 101 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Will evaluate RFS of single agent adjuvant nivolumab plus placebo compared to the combination treatment of adjuvant nivolumab plus cabozantinib in patients with resected mucosal melanoma.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Bone Scan
- DRUG Cabozantinib S-malate
- PROCEDURE Echocardiography Test
Study Locations (20)
California
- Sutter Auburn Faith Hospital - Auburn
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Palo Alto Medical Foundation-Fremont - Fremont
- Keck Medicine of USC Koreatown - Los Angeles
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Memorial Medical Center - Modesto
- USC Norris Oncology/Hematology-Newport Beach - Newport Beach
- Palo Alto Medical Foundation Health Care - Palo Alto
- Stanford Cancer Institute Palo Alto - Palo Alto
- Sutter Roseville Medical Center - Roseville
- Sutter Medical Center Sacramento - Sacramento
- California Pacific Medical Center-Pacific Campus - San Francisco
- UCSF Medical Center-Mission Bay - San Francisco
- Mills Health Center - San Mateo
- Palo Alto Medical Foundation-Santa Cruz - Santa Cruz
- Sutter Pacific Medical Foundation - Santa Rosa
- Palo Alto Medical Foundation-Sunnyvale - Sunnyvale
- Sutter Solano Medical Center/Cancer Center - Vallejo
Colorado
- The Melanoma and Skin Cancer Institute - Englewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2022-08-11 |
| Est. Completion | 2026-06-01 |
| Phase | Phase 2 |
What NCT05111574 shows while recruiting
NCT05111574 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 146-participant average among 12 other Mucosal Melanoma trials with a reported enrollment target (31% lower).
The record links to 10 conditions, with Mucosal Melanoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05111574 names 20 study sites across 2 states, led by California, Colorado.
Frequently Asked Questions
What is clinical trial NCT05111574 about?
NCT05111574 is a clinical study titled "Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery". 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...
What is the current status of trial NCT05111574?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 101 participants. The study started on 2022-08-11. Estimated completion is 2026-06-01.
What conditions does trial NCT05111574 study?
This clinical trial studies the following conditions: Mucosal Melanoma, Anal Melanoma, Bladder Melanoma, Cervical Melanoma, Esophageal Melanoma.
What interventions are being tested in trial NCT05111574?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Bone Scan (PROCEDURE), Cabozantinib S-malate (DRUG), Echocardiography Test (PROCEDURE).
Who is sponsoring clinical trial NCT05111574?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05111574 being conducted?
This trial has 20 study locations across California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Mucosal Melanoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05111574's enrollment target sits among peer trials
101 4th of 12 higher than 9 of 12 other Mucosal Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mucosal Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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Ipilimumab and Nivolumab as Adjuvant Treatment of Mucosal Melanoma
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-
Testing Treatment With Ipilimumab and Nivolumab Compared to Treatment With Ipilimumab Alone in Advanced Melanoma
COMPLETED · Phase 2
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