A Phase IB/II Study of APX005M Immunotherapy plus Gemcitabine and nab-Paclitaxel, with or without Nivolumab, in Patients with Previously Untreated Metastatic Pancreatic Cancer

Full Title

PICI0002: Open-label, Multicenter, Phase 1b/2 Clinical Study to Evaluate the Safety and Efficacy of CD40 Agonistic Monoclonal Antibody (APX005M) Administered Together with Gemcitabine and nab-Paclitaxel with or without PD-1 Blocking Antibody (Nivolumab) in Patients with Previously Untreated Metastatic Pancreatic Adenocarcinoma (U. of Penn)

Purpose

The goal of this study is to evaluate the safety and effectiveness of the investigational immunotherapy drug APX005M when given in combination with gemcitabine, nab-paclitaxel, and nivolumab immunotherapy in patients with previously untreated metastatic pancreatic cancer. APX005M is designed to boost the immune response against cancer by targeting a protein on cancer cells called CD40.

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 mechanism by expressing PD-L1, enabling them to escape attack by the body’s white blood cells. Nivolumab blocks PD-1, enhancing the body’s ability to detect and destroy cancer cells. It is used to treat several types of cancer; its use in this study is considered investigational.

Gemcitabine and nab-paclitaxel are standard chemotherapy drugs used to treat pancreatic cancer. In the Phase IB part of this study, patients will receive one of two doses of APX005M plus gemcitabine and nab-paclitaxel, with or without nivolumab. In the Phase II portion of the study, patients will receive gemcitabine and nab-paclitaxel with APX005M, with nivolumab, or with both APX005M and nivolumab. All of the medications 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 metastatic pancreatic cancer and may not have previously received treatment for metastatic disease.
  • Prior treatment before or after pancreatic cancer surgery is permitted, but at least 4 months must pass between the completion of therapy 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. Eileen O’Reilly at 646-888-4182.

Protocol

17-490

Phase

I/II

Investigator

Co-Investigators