An Exploratory Study of Nivolumab with or without Ipilimumab Immunotherapy According to Tumor CD8 Level in Patients with Advanced Cancer

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Full Title

An Exploratory Study of Nivolumab with or without Ipilimumab According to the Percentage of Tumoral CD8 Cells in Participants with Advanced Metastatic Cancer (MD Anderson)

Purpose

Nivolumab and ipilimumab are immunotherapy drugs that take the brakes off the immune response, allowing the immune system to find and destroy cancer cells. Nivolumab is approved by the U.S. Food and Drug Administration as a single therapy for patients with a variety of advanced cancers, including melanoma, and ipilimumab is also used to treat melanoma. Both drugs are approved by the FDA to be used together for melanoma.

The goal of this study is to assess the combination of nivolumab plus ipilimumab in patients with advanced cancers. Patients whose tumors have high levels of CD8-positive T cells (a type of immune cell) will receive nivolumab alone, and those with low levels of CD8 T cells will receive nivolumab plus ipilimumab. 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 advanced cancer that cannot be successfully treated using standard therapies.
  • At least 2 weeks must pass between the completion of prior therapies and entry into the study.
  • Patients must have tumors that can be tested for CD8.
  • 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. Danny Khalil at 646-888-4384.

Protocol

19-014

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators