Nivolumab or Expectant Observation Following Ipilimumab, Nivolumab, and Surgery in Treating Patie… (NCT03220009) | Clinical Trial Compass
WithdrawnPhase 2
Nivolumab or Expectant Observation Following Ipilimumab, Nivolumab, and Surgery in Treating Patients With High Risk Localized, Locoregionally Advanced, or Recurrent Mucosal Melanoma
Stopped: The study was never approved by CTEP neither was it ever activated
United States0Started 2017-11-03
Plain-language summary
This randomized phase II trial studies how well nivolumab or expectant observation following ipilimumab, nivolumab, and surgery work in treating patients with high-risk mucosal melanoma that is restricted to the site of origin without evidence of spread, has spread to a local and regional area of the body, or has come back. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread. Sometimes the mucosal melanoma may not need more treatment until it progresses. In this case, observation may be sufficient. It is not known if nivolumab or expectant observation following ipilimumab, nivolumab, and surgery may be better in treating patients with mucosal melanoma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* STEP 1 ELIGIBILITY CRITERIA
* Documentation of disease:
* Histologic documentation: histologically proven mucosal melanoma by local pathology
* Tumor tissue: tumor tissue from the primary site of disease must be available for PD-L1 testing (stratification factor)
* Disease status
* Tumors must have NOT been completely resected, or must be locoregionally recurrent if previously resected; tumor must be deemed potentially resectable by local surgeon
* MM arising from the head/neck, genitourinary, or gastrointestinal tract
* Disease meets any 1 of 4 characteristics:
* Regional lymph node (LN) involvement; OR
* Multifocal/satellite primary disease; OR
* Single localized, primary disease meeting one of the following site-specific requirements:
* Head/neck - any primary lesion if sinonasal; pT4a or above for nasal or oral cavity
* Anorectal - any primary lesion
* Conjunctiva - any primary lesion T2 or T3 stage by American Joint Committee on Cancer (AJCC)
* Vaginal/cervical - any primary
* Vulvar (hair bearing surface, labia majora) - AJCC cutaneous stage IIB or higher
* Esophageal - any primary
* Locoregionally recurrent following prior resection
* No evidence of metastatic disease at the time of registration
* No prior medical therapy (chemotherapy, immunotherapy, biologic or targeted therapy) or radiation therapy for MM, unless locoregionally recurrent; if recurrent, no prior medical or radi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recurrence free survival (RFS)
Timeframe: From randomization to either adjuvant nivolumab or observation until evidence of disease recurrence, assessed up to 5 years