A Phase I Study of Ipilimumab and Nivolumab Immunotherapy plus Radiation Therapy for Metastatic Melanoma

Full Title

A Phase 1 Study to Evaluate the Safety and Efficacy of Combination Checkpoint Blockade (Ipilimumab and Nivolumab) Plus External Beam Radiotherapy in Subjects with Stage IV Melanoma

Purpose

Ipilimumab and nivolumab are immunotherapy drugs that can be used in combination to treat advanced melanoma. They work by inhibiting proteins that normally put the brakes on the immune response, thereby stimulating the immune system to recognize and kill cancer cells. Doctors believe that adding radiation therapy to treatment with these two drugs may further enhance this immune response.

In this study, researchers are evaluating the safety of giving ipilimumab and nivolumab with radiation therapy in patients with metastatic melanoma. Patients will receive the two drugs with either standard radiation therapy or high-dose radiation therapy. Ipilimumab and nivolumab are both 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 metastatic melanoma and may have received any number of prior therapies.
  • At least 6 weeks must pass between the completion of prior immunotherapy and entry into the study, and 4 weeks since other treatments.
  • 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

16-380

Phase

I

Investigator

Diseases

Locations