A Phase II/III Study of Immunotherapy with Nivolumab, Ipilimumab, and GM-CSF in Patients with Advanced Melanoma

Share
Print

Full Title

Randomized Phase II/III Study of Nivolumab plus Ipilimumab plus Sargramostim versus Nivolumab plus Ipilimumab in Patients with Unresectable Stage III or Stage IV Melanoma (EA6141) (CIRB)

Purpose

Nivolumab and ipilimumab are immunotherapy drugs used to treat advanced melanoma. In this study, researchers are assessing the safety and effectiveness of combining nivolumab and ipilimumab immunotherapy with another drug used in cancer care called GM-CSF (sargramostim) in patients with advanced melanoma.

Colony-stimulating factors, such as GM-CSF, may increase the production of white blood cells. It is hoped that the combination of these three medications will further boost the immune response against melanoma cells and decrease the side effects of immunotherapy. Patients in this study will be randomly assigned to receive nivolumab and ipilimumab with or without GM-CSF. Nivolumab and ipilimumab are given intravenously (by vein) and GM-CSF is given as a subcutaneous (under the skin) injection.

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 inoperable or metastatic melanoma. Patients with brain metastases may not participate.
  • At least 4 weeks must pass between the completion of prior therapies and receipt of the study treatment. Prior immunotherapy for metastatic melanoma is not permitted.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and 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. Allison Betof Warner at 646-888-6854.

Protocol

20-471

Phase

II/III

Investigator

Co-Investigators