A Phase II Study of Immunotherapy: Ipilimumab Alone or with Nivolumab in Patients Whose Melanoma Continues to Grow Despite Nivolumab or Pembrolizumab

Full Title

A Randomized, Phase 2 Study of Ipilimumab vs Ipilimumab Plus Nivolumab in Patients with Stage III-IV Melanoma who have Progressed or Relapsed on PD-1 Inhibitor Therapy

Purpose

The purpose of this study is to see whether it is better to combine the immunotherapy drugs ipilimumab and nivolumab or to give ipilimumab alone in patients whose melanoma tumors have continued to grow despite prior therapy with nivolumab or another immunotherapy called pembrolizumab. Nivolumab and pembrolizumab work by blocking a molecule called PD-1 that shuts down the immune response. 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. Both types of drugs can allow the immune system to detect and attack 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. Ipilimumab is already approved for treating melanoma. It is also approved to be used in combination with nivolumab for the initial treatment of metastatic melanoma, but the combination in patients who have been previously treated with nivolumab or pembrolizumab is considered investigational.

Patients in this study will be randomly assigned to receive ipilimumab alone or ipilimumab plus nivolumab. 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 stage III or IV melanoma of the skin that has continued to grow despite prior treatment with nivolumab or pembrolizumab.
  • Patients may not have previously received ipilimumab.
  • 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 about this study and to inquire about eligibility, please contact Dr. Jedd Wolchok at 646-888-2395.

Protocol

16-043

Phase

II

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