Nivolumab or Expectant Observation Following Ipilimumab, Nivolumab, and Surgery in Treating Patients With High Risk Localized, Locoregionally Advanced, or Recurrent Mucosal Melanoma

Withdrawn before enrolling · Phase 2

Conditions studied: Cervical Carcinoma, Esophageal Carcinoma, Mucosal Melanoma, Mucosal Melanoma of the Head and Neck, Oral Cavity Mucosal Melanoma, Recurrent Melanoma, Stage II Vulvar Cancer AJCC v7, Stage III Vulvar Cancer AJCC v7, Stage IIIA Vulvar Cancer AJCC v7, Stage IIIB Vulvar Cancer AJCC v7, Stage IIIC Vulvar Cancer AJCC v7, Stage IV Oral Cavity Cancer AJCC v6 and v7, Stage IV Vulvar Cancer AJCC v7, Stage IVA Oral Cavity Cancer AJCC v6 and v7, Stage IVB Oral Cavity Cancer AJCC v6 and v7, Stage IVC Oral Cavity Cancer AJCC v6 and v7, Vaginal Carcinoma

In brief

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.

Key facts

Study ID

NCT03220009

Run by

National Cancer Institute (NCI)

People needed

0

Starts

2017-11-03

Expected to finish

2021-07-01

Last updated by the study team

2018-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 radiation therapy is allowed for the latest recurrence
• No history of the following:
• Active known or suspected autoimmune disease
• Human immunodeficiency virus (HIV) with CD4+ count < 300 or detectable viral load; patients with HIV, undetectable viral load, and CD4+ count >= 300 are eligible
• Known active hepatitis B or C
• Hepatitis B can be defined as:

Where it is running

• Alliance for Clinical Trials in Oncology — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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