Adding Pembrolizumab to Olaparib to Treat Pancreatic Cancer in People with an Inherited BRCA Mutation

About the Study

This study is researching whether adding the immunotherapy drug Pembrolizumab (Keytruda) to the PARP inhibitor Olaparib (Lynparza) works better than olaparib alone in treating people with metastatic pancreatic cancer who also have an inherited BRCA1 or BRCA2 mutation.  

Type of Study

This is a randomized, open label, two-arm study.

• The study is divided into two separate treatment groups: one group will receive olaparib alone, the other group will receive both olaparib and pembrolizumab. 
• This is a randomized study, which means that people will not choose which treatment they receive, but will be selected by chance to be one of the treatment groups. Neither patients in the study nor the doctor will get to decide which group participants are placed in.
• The study is open label, which means that once they are placed in a group, participants will know which group they are in and which drugs they will receive. 

What the Study Entails:

Both groups:

• Patients in both Group 1 and Group 2 will receive olaparib orally twice per day on days 1-21. Cycles repeat every 21 days as long as the participant doesn't have serious side effects. 
• Patients are followed for up to 3 years.

Group 1

• Patients in Group 1 will also receive Pembrolizumab intravenous (IV) over 30 minutes on day 1 of each cycle for up to 18 cycles as long as the.participant doesn't experience serious side effects. 
• Beginning with cycle 19, patients will receive Olaparib orally twice per day on days 1-42 and continue with Pembrolizumab IV over 30 minutes on day 1 of each cycle. These cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.  

Men and women age 18 years or older can participate if they meet the following criteria:

• Have metastatic pancreatic cancer.
• Have a hereditary BRCA1 or BRCA2 mutation.
• Have received first line platinum-based chemotherapy (i.e. fluorouracil, irinotecan, leucovorin and oxaliplatin [FOLFIRINOX], leucovorin calcium, 5-fluorouracil, and oxaliplatin [FOLFOX], or gemcitabine + cisplatin) for at least 16 weeks but no more than 24 weeks.
• Have had a CT scan or MRI showing stable or responding disease on first line platinum-based chemotherapy within 30 days prior to registration.

People are not eligible to participate if they:

• have with a known hypersensitivity to olaparib.
• have already received a type of immunotherapy known as an immune checkpoint inhibitor.
• have had prior therapy with PARP inhibitors.
• are pregnant or nursing