A Phase II Study of Pembrolizumab Immunotherapy and OLApaRib (POLAR) Maintenance Therapy for Patients with Metastatic Pancreatic Cancer

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Full Title

A Phase 2 Trial to Evaluate the Safety and Antitumor Activity of Pembrolizumab and OLApaRib (POLAR) Maintenance for Patients with Metastatic Pancreatic Ductal Adenocarcinoma and Homologous Recombination Deficiency and/or Exceptional Treatment Response to Platinum-Based Therapy

Purpose

The purpose of this study is to assess the safety and effectiveness of combining pembrolizumab immunotherapy with olaparib (POLAR therapy) in patients with metastatic pancreatic cancer that has a genetic mutation called HRD (homologous recombination deficiency) and/or has had an exceptional response to platinum-based chemotherapy for more than 6 months. This combination of medications is considered investigational. 

POLAR may be effective because pembrolizumab activates the immune system to fight cancer, and olaparib destroys cancer cells by preventing them from repairing damage to the cancer’s genetic information that may help tumors survive and grow. It is hoped that combining these drugs may be a more effective treatment for metastatic pancreatic cancer than olaparib alone. Pembrolizumab is given intravenously (by vein) and olaparib is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic pancreatic ductal adenocarcinoma with an HRD gene mutation and/or has had an exceptional response to platinum-based chemotherapy for 4-6 months or more.
  • Prior treatment with PD-1 immunotherapy (the class of drugs to which pembrolizumab belongs) or PARP inhibitors (such as olaparib) is not permitted.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Wungki Park at 646-888-4543.

Protocol

20-481

Phase

II

Disease Status

Newly Diagnosed

Investigator

Co-Investigators