A Phase I Study of Personalized Tumor Vaccines and Atezolizumab Immunotherapy in Patients with Operable Pancreatic Cancer

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Full Title

Phase 1 Clinical Trial of Personalized Neoantigen Tumor Vaccines and Programmed Death-Ligand 1 (PD-L1) Blockade in Patients with Surgically Resected Pancreatic Cancer

Purpose

The purpose of this study is to assess the safety of an investigational treatment, RO7198457 (also called a personalized cancer vaccine or PCV), given in combination with atezolizumab immunotherapy and a standard combination of chemotherapy drugs in patients with pancreatic cancer that can be treated with surgery.

The vaccine will be customized according to unique changes (mutations) in tumor cells that can be recognized by the patient’s immune system, so the immune system will selectively target the tumor. Researchers believe that after the immune cells have been “trained” by the vaccine, they will continue to target tumor cells. It may take about two months to make each patient’s personalized vaccine.

Atezolizumab is designed to improve the immune system’s ability to recognize and destroy cancer cells by blocking PD-L1, a protein some cancers make to evade detection by the immune system. In this study, patients will first have pancreatic cancer surgery, followed by atezolizumab treatment, PCV, and chemotherapy. All treatments 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 stage I-III pancreatic cancer that can be surgically treated and has not yet been treated with chemotherapy, radiation therapy, or immunotherapy.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and 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. Vinod Balachandran at 212-639-5785.

Protocol

19-039

Phase

I

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators