A Phase II Study of Cabiralizumab plus Nivolumab Immunotherapy with or without Chemotherapy in Patients with Advanced Pancreatic Cancer

Full Title

A Phase 2 Study of Cabiralizumab (BMS-986227, FPA008) Administered in Combination with Nivolumab (BMS-936558) with and without Chemotherapy in Patients with Advanced Pancreatic Cancer

Purpose

The purpose of this study is to determine if giving immunotherapy with chemotherapy in patients with persistent advanced pancreatic cancer is more effective than immunotherapy or chemotherapy individually. Patients will be randomly assigned to receive one of these treatments:

  • Chemotherapy with gemcitabine/nab-paclitaxel; 5-fluorouracil/leucovorin/irinotecan liposome; or leucovorin, 5-fluorouracil and irinotecan.
  • Combination treatment with cabiralizumab and nivolumab immunotherapy.
  • Cabiralizumab and nivolumab immunotherapy in combination with gemcitabine and nab-paclitaxel chemotherapy.

Nivolumab inhibits a protein that cancer cells use to hide from the immune system; it boosts the power of the immune system to find and kill cancer cells. Cabiralizumab helps fight cancer by targeting cells called macrophages. It slows down the build-up of specific macrophages around a tumor that have been known to promote tumor growth, so chemotherapy and immunotherapy drugs such as nivolumab can attack the tumor.

The use of cabiralizumab and nivolumab in pancreatic cancer is considered investigational. All of the medications used in this study 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 inoperable or metastatic pancreatic cancer that has continued to grow despite one prior regimen of treatment.
  • Patients may not have previously received immunotherapy.
  • At least 4 weeks must pass between the completion of prior 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. Kenneth Yu at 646-888-4188.

Protocol

18-302

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators