A Phase I Study of Lirilumab plus Nivolumab in Patients with Advanced Solid Tumors

Protocol
12-224
Full Title
A Phase I Dose Escalation and Cohort Expansion Study of the Safety, Tolerability and Efficacy of Anti-KIR (Lirilumab) Administered in Combination with Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors
Phase
I
Purpose

The purpose of this study is to find the highest dose of the investigational drug lirilumab that can be given safely with nivolumab in patients with advanced solid tumors that are no longer responding to standard therapies.

Nivolumab works by attaching to and blocking a molecule called PD-1. Lirilumab attaches to and blocks a group of molecules called KIR. PD-1 and KIR are proteins present mainly on immune system cells, and each controls part of the immune system by shutting it down. It is hoped that by binding to and inactivating these proteins, this drug combination can enhance the body’s ability to detect and destroy cancer cells.

Nivolumab is approved for treating advanced melanoma; its use for treating other cancers 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 a metastatic or inoperable solid tumor that is no longer responding to standard therapies, including at least one prior regimen of therapy for advanced cancer.
  • At least 4 weeks must have passed since completion of prior therapy and entry into the study.
  • Patients may not have had prior treatment with drugs that block PD-1 or KIR.
  • 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 ages 18 and older.

For more information about this study and to inquire about eligibility, please contact the office of Dr. Neil H. Segal at 646-888-4187.

Disease(s)
Colorectal Cancer
Kidney Cancer
Lung Cancer, Non-Small Cell
Melanoma
Ovarian Cancer
Locations