A Phase I Study of BMS-986016 Alone and with Nivolumab in Patients with Advanced Solid Tumors

Protocol
14-010
Full Title
A Phase 1 Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination with Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors
Phase
I
Purpose

Nivolumab boosts the body’s immune system by targeting a protein on white blood cells called PD-1. PD-1 normally maintains the balance of the immune system by shutting it down at the right time. Some cancers take advantage of this shut-down mechanism by activating PD-1, enabling them to escape attack by the body’s immune system. Nivolumab binds to and inactivates PD-1, enhancing the body’s ability to detect and destroy cancer cells.

BMS986016 is also an investigational drug designed to provoke an immune response against cancer cells. While nivolumab targets PD-1, BMS-986016 targets a protein called LAG-3. In this study, researchers want to find the highest dose of BMS-986-016 that can be given alone and in combination with nivolumab in patients with solid tumors that have spread despite prior therapy.

Nivolumab is approved for treating advanced melanoma; its use for treating other cancers is considered investigational. Both nivolumab and BMS-986016 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 an advanced solid tumor (any type except primary brain and spinal cord cancers) that has spread despite therapy.
  • Patients must have recovered from any serious side effects of prior treatment before they enter 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 open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Margaret Callahan at 646-888-3579.

Disease(s)
Solid Tumors
Locations