A Phase II Study of Immunotherapy with Ipilimumab plus Nivolumab for Patients with Melanoma that Has Spread to the Brain

Full Title

A Multi-Center Phase 2 Open-Label Study to Evaluate Safety and Efficacy in Subjects with Melanoma Metastatic to the Brain Treated with Nivolumab in Combination with Ipilimumab Followed by Nivolumab Monotherapy

Purpose

Ipilimumab and nivolumab are immunotherapies that are both approved by the FDA to treat advanced melanoma, both individually and when given together. In this study, researchers are evaluating the safety and effectiveness of giving these two drugs together in patients with melanoma involving the brain.

Nivolumab and ipilimumab both work by stimulating an immune response against melanoma. Nivolumab boosts the body's immune system by targeting a protein on white blood cells called PD-1. PD-1 normally maintains the balance of the immune system by shutting it down at the right time. Some cancers take advantage of this mechanism by expressing PD-L1, enabling them to escape attack by the body's white blood cells. Nivolumab blocks PD-1, enhancing the body's ability to detect and destroy cancer cells. Ipilimumab is an antibody against CTLA-4, a molecule that controls a part of the immune system by shutting it down at the right time.

Patients in this study will first receive nivolumab and ipilimumab during the induction therapy period. After that, they will nivolumab alone as maintenance therapy. Both drugs are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have melanoma that has spread to the brain and have a lesion that is at least 0.5 cm in diameter but no larger than 3 cm.
  • Patients must recover from the serious side effects of prior therapies before entering the study. At least 3 weeks must pass since completion of prior radiation therapy or chemotherapy.
  • Previous treatment with ipilimumab, nivolumab, or any inhibitor of PD-1 is not permitted.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Michael Postow at 646-888-4589.

Protocol

15-094

Phase

II

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