PhII Olaparib + Pembrolizumab vs. Olaparib in Met Pancreatic Ca Pts w /Germline BRCA1 or BRCA2 Mut

UCI Specialty Area: Cancer

Principal Investigator: Jennifer Brooke Valerin

Official Title: Randomized Phase II Clinical Trial of Olaparib + Pembrolizumab vs. Olaparib Alone as Maintenance Therapy in Metastatic Pancreatic Cancer Patients with Germline BRCA1 or BRCA2 Mutations

A Study On:

Pancreas

Study Description

The purpose of this study is to compare the usual treatment (olaparib) alone to using pembrolizumab plus the usual treatment. The addition of pembrolizumab to the usual treatment could help to shrink your cancer but, it could also cause side effects. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study drug pembrolizumab increases the time it takes for the cancer to grow by 5 months or more compared to the usual approach.

Olaparib alone has been approved as maintenance therapy for patients with germline BRCA1 or BRCA2 mutated pancreatic cancer.

Eligibility

Eligibility Criteria:

Patient must have histological or cytological diagnosis of pancreatic adenocarinoma.
Patient must have one of the following mutations: germline mutation in BRCA 1 or 2 from a CLIA certified lab defined as positive and/or deleterious (pathogenic or likely pathogenic variant).
Patient must have metastatic disease and received first line platinum-based chemotherapy (i.e. FOLFIRINOX, FOLOFX, gemcitabine + nab-paclitaxel + cisplatin or gemcitabine + cisplatin).

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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