A Phase I/II Study of Immunotherapy with Ulocuplumab plus Nivolumab in Patients with Pancreatic and Small Cell Lung Cancers

Full Title

A Phase 1/2 Study of the Safety and Efficacy of Ulocuplumab Combined with Nivolumab in Subjects with Advanced or Metastatic Solid Tumors

Purpose

Immune therapies with single drugs have been shown to be effective for slowing the growth of cancers such as melanoma, kidney cancer, and bladder cancer. However, single-drug immune therapies have not be as effective for treating pancreatic and small cell lung cancers because these cancers have a tough, protective coating called a stroma. A combination of immune therapies may be needed to stimulate immune cells to penetrate this stroma and attack the cancer.

In this study, researchers want to find the highest dose of the investigational drug ulocuplumab that can be given with the immunotherapy nivolumab in patients with metastatic pancreatic cancer or small cell lung cancer that has continued to grow despite prior therapy. Both drugs stimulate the immune system to recognize and attack cancer cells.

Nivolumab is approved for treating several types of cancer; its use in this study is considered investigational. Both nivolumab and ulocuplumab 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 metastatic pancreatic cancer or small cell lung cancer that has continued to grow despite prior treatment.
  • At least 3 weeks must pass between the completion of prior therapies and entry into the study.
  • Patients may not have had prior immune therapies that work through similar pathways as nivolumab and ulocuplumab.
  • 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. Eileen O'Reilly at 646-888-4182.

Protocol

15-179

Phase

I/II

Investigator

Locations