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 range18 Years
SexALL
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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…
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