A Study of Pembrolizumab and Olaparib for People With Metastatic Pancreatic Ductal Adenocarcinoma and Homologous Recombination Deficiency or Exceptional Treatment Response to Platinum-Based Therapy
NCT04666740 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63
Last updated 2026-02-18
Summary
The study researchers think that combining the drugs pembrolizumab and olaparib (POLAR) may help people with this disease because pembrolizumab activates the immune system to fight cancer, and olaparib destroys cancer cells by preventing them from repairing damage to the genetic information that helps them survive and grow. The study researchers are doing this study to find out whether combining these drugs may be a more effective treatment for this cancer than taking olaparib alone.
Conditions
- Metastatic Pancreatic Ductal Adenocarcinoma
- Homologous Recombination Deficiency (HRD)
Interventions
- DRUG
-
Pembrolizumab 200 mg IV every 3 week. After the first 6 months (8 cycles), on C9D1 Pembrolizumab 400 mg IV every 6 week.
- DRUG
-
Olaparib 300 mg twice day orally daily continuously (POLAR) as a maintenance therapy. After the first 6 months (8 cycles), on C9D1 olaparib 300 mg twice a day orally will be continued.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Memorial Sloan Kettering Cancer Center
lead OTHER
Principal Investigators
-
Wungki Park, MD · Memorial Sloan Kettering Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-18
- Primary Completion
- 2027-01-31
- Completion
- 2027-01-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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