PRIMARY OBJECTIVE:~I. To determine the maximum tolerated dose (MTD) of ipilimumab that can be administered through the DoseConnect device followed 30 minutes later by nivolumab intravenously (IV) on day 1 of a 21-day cycle in patients with metastatic melanoma. (Dose-De-escalation Cohort)~SECONDARY OBJECTIVE:~I. To assess the pharmacokinetics of ipilimumab administered using the DoseConnect followed 30 minutes later by nivolumab IV in patients with metastatic melanoma demonstrating in-transit metastases. (Dose De-escalation Cohort)~CORRELATIVE OBJECTIVE:~I. To assess the changes in immunologic profile after one cycle of ipilimumab administered using the DoseConnect followed 30 minutes later by nivolumab IV. (Dose-De-escalation Cohort)~OUTLINE:~Patients receive ipilimumab via DoseConnect on day 1 of cycle 1 and via IV over 30 minutes on day 1 of cycles 2-4. Patients also receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.~After completion of study treatment, patients are followed up every 4 months until disease progression, and then every 6 months for up to 2 years after registration.
This phase I trial identifies the best dose of ipilimumab that can be administered through the DoseConnect device followed by nivolumab in treating patients with stage III-IV melanoma that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.