A Phase I/II Study of BMS-986249 Alone or with Nivolumab Immunotherapy for Patients with Advanced Cancer

Full Title

A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination with Nivolumab in Advanced Solid Tumors

Purpose

The purpose of this study is to find the highest dose of the investigational drug BMS-986249 that can be given safely with nivolumab immunotherapy in patients with advanced solid tumors that persist despite prior therapy. Both drugs work by inhibiting proteins that normally put the brakes on the immune response, enhancing the power of the immune system to find and destroy cancer cells. Nivolumab inhibits the PD-1 protein, while BMS-986249 targets a protein called CTLA-4. They are given intravenously (by vein).

BMS-986249 is a modified form of an immunotherapy called ipilimumab, which has been studied extensively in combination with nivolumab. BMS-986249 was designed to reduce the most common side effects associated with ipilimumab. Researchers modified the molecule so BMS-986249 becomes active only when the drug gets to the tumor, rather than being activated throughout the entire body.

Patients will receive BMS-986249 alone or in combination with nivolumab.

Eligibility

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

  • Patients must have an inoperable, recurrent, or metastatic solid tumor that persists despite prior treatment. These include small cell and non-small cell lung cancer, castration-resistant prostate cancer, colorectal cancer, renal cell cancer, bladder cancer, stomach cancer, esophageal cancer, and melanoma.
  • At least 4 weeks must pass between the completion of previous therapies and entry into the study.
  • 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. Claire Friedman at 646-888-4247.

Protocol

18-273

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators