A Phase I Study of BMS-986015 with Ipilimumab in Patients with Advanced Non-Small Cell Lung Cancer, Prostate Cancer, or Melanoma

Protocol
12-283
Full Title
A Phase I Study of BMS-986015, an Anti-KIR Monoclonal Antibody, Administered with Ipilimumab, an Anti-CTLA4 Monoclonal Antibody, in Subjects with Select Advanced Solid Tumors
Phase
I
Purpose

The purpose of this study is to determine the highest dose of the investigational drug BMS-986015 that can be given together with ipilimumab in patients with advanced non-small cell lung cancer, prostate cancer, or melanoma that persists despite standard therapy. Researchers hope that these two drugs given in combination may help the immune system kill cancer cells.

BMS-986015 attaches to and blocks KIR proteins, which are present mainly on immune system cells called natural killer cells and which control part of the immune system by shutting it down. It is hoped that by binding to and inactivating KIR proteins, BMS-986015 can activate natural killer cells to attack and kill tumor cells.

Ipilimumab is an antibody against CTLA-4, a molecule that controls a part of the immune system by shutting it down. Researchers believe that one way cancers can escape the immune system could be through this shut-down mechanism. An antibody against CTLA-4 could stop it from turning off the immune system, and allow an immune reaction to continue. This immune reaction may help the body to destroy cancer cells. Ipilimumab is approved for treating melanoma; its use in combination with BMS-986015 in this study is considered investigational.

Eligibility

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

  • Patients must have advanced non-small cell lung cancer, castration-resistant prostate cancer, or advanced melanoma that persists despite at least one but no more than five prior regimens of standard therapy.
  • At least 4 weeks must have passed since completion of prior therapy and the first dose of the study medication.
  • 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. Naiyer Rizvi at 646-888-4204.

Disease(s)
Lung Cancer, Non-Small Cell
Melanoma
Prostate Cancer: Metastatic Disease after Hormone-Reducing Therapy
Solid Tumors
Locations
Related Diseases