A Phase I/IIA Study of BMS-986218 with or without Nivolumab Immunotherapy in Patients with Advanced Solid Tumors

Full Title

CA022001: Phase 1/2a First-In-Human Study of BMS-986218 Monoclonal Antibody Alone and in Combination with Nivolumab in Advanced Solid Tumors

Purpose

BMS-986218 is an investigational immunotherapy drug. It boosts the power of the immune system to find and kill cancer cells by inhibiting a protein called CTLA-4, which normally puts the brakes on the immune response. In this study, researchers are finding the highest dose of BMS-986218 that can be given safely alone and in combination with another immunotherapy drug called nivolumab in patients with advanced solid tumors that came back or continue to grow despite prior therapy.

Nivolumab enhances the immune response by inhibiting a protein called PD-1. It is approved for treating several types of cancer; its use in this study is considered investigational. Both BMS-986218 and nivolumab 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 a metastatic, recurrent, or inoperable solid tumor that persists despite all prior standard treatments.
  • 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 about this study and to inquire about eligibility, please contact Dr. Claire Friedman at 646-888-4247.

Protocol

17-332

Phase

I/II

Investigator

Co-Investigators