Ipilimumab and Nivolumab as Adjuvant Treatment of Mucosal Melanoma

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Robert R. McWilliams, MD

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a single arm phase II clinical trial of Ipilimumab and Nivolumab in patients with resected mucosal melanoma. Ipilimumab (1 mg/kg) and Nivolumab (3 mg/kg) will be administered Day 1 of a 21-day cycle in Cycles 1-4 and then nivolumab 480 mg will be administered Day 1 of a 28-day cycle for Cycles 5-15 (maximum of 15) or until disease recurrence or intolerance before completion of 15 cycles.

Research Team

Robert R. McWilliams, MD

Principal Investigator

Hoosier Cancer Research Network

Eligibility Criteria

Inclusion Criteria

- Hepatic: Alkaline Phosphatase (Alk Phos) ≤ 1.5 x upper limit of normal (ULN), Total and Direct Bilirubin ≤ 1.5 × (ULN), Aspartate aminotransferase (AST) ≤ 1.5 × ULN

You are willing to give a small piece of your previous tissue sample and some blood samples for additional research purposes.

Histological confirmation of melanoma of any mucosal site including (but not limited to) anus/rectum, vulvar/vaginal, sinonasal. NOTE: Melanomas of cutaneous origin and/or ocular origin are ineligible.

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Exclusion Criteria

Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the subject inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.

Immunocompromised patients and subjects known to be HIV positive and currently receiving antiretroviral therapy. NOTE: Subjects known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.

Other active malignancy ≤ 3 years prior to registration. EXCEPTIONS: Malignancies with a very low (< 5%) risk of recurrence such as non-melanotic skin cancer or carcinoma-in-situ of the cervix.

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Treatment Details

Interventions

Ipilimumab and Nivolumab (Checkpoint Inhibitor)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Ipilimumab (1 mg/kg) + Nivolumab (3 mg/kg) IVExperimental Treatment2 Interventions

Cycles 1-4: Ipilimumab (1 mg/kg) + Nivolumab (3 mg/kg) IV Day 1 of each Cycle Each Cycle = 21 days Cycles 5-15: Nivolumab IV 480 mg Day 1 of each Cycle Each Cycle = 28 days