drugset / Trial / NCT04666740
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
Phase 2
Active not recruiting
63 enrolled
Memorial Sloan Kettering Cancer Center
Merck Sharp & Dohme LLC · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2020-12-18
- Primary completion
- 2027-01
- Completion
- 2027-01
Outcome
Missed primary endpoint
paper For Cohort A, ORR was 35% (95% CI: 15-59) and 6-month-PFS rate was 64% (95% CI: 49-82), not meeting the primary endpoint. PMID 40951294 ↗
Publications
- Park W, O'Connor CA, Chou JF, Hilmi M, Tarcan Z, Schwartz C, Larsen M, Homsi R, Sivaprakasam K, Umeda S, Perry MA, Varghese AM, Yu KH, Balogun F, Zervoudakis A, Katz SS, Kim TH, Zhao K, Richards AL, Lecomte N, Martin Muldoon D, Karnoub E, Chatila W, Yang J, El-Dika I, Rao D, Joshi S, Foote MB, Sugarman R, Harding JJ, Epstein AS, Kelsen D, Chalassani S, Keane F, Schoenfeld JD, Singhal A, Diguglielmo E, Bandlamudi C, Song J, Ozkan HS, Hong J, Zhang H, Cardenas AI, Lao M, Melchor J, Shah R, Kang W, Mazzoni F, Soares K, Donoghue MT, Santos E, Rolston V, Reyngold M, Wei AC, Tipping M, Basturk O, Berger M, Kihn Do R, Schattner M, Jarnagin WR, Riaz N, Balachandran V, Pe'er D, Capanu M, Iacobuzio-Donahue C, O'Reilly EM. Pembrolizumab and olaparib in homologous-recombination-deficient metastatic pancreatic cancer: the phase 2 POLAR trial. Nat Med. 2026 May;32(5):1783-1793. doi: 10.1038/s41591-026-04299-5. Epub 2026 Mar 25.
- Park W, O'Connor C, Chou J, Hilmi M, Tarcan Z, Schwartz C, Larsen M, Chatila W, Sivaprakasam K, Umeda S, Perry M, Varghese A, Yu K, Balogun F, Zervoudakis A, Katz S, Kim TH, Zhao K, Richards A, Lecomte N, Muldoon D, Karnoub E, Yang J, El-Dika I, Rao D, Smita J, Foote M, Sugarman R, Harding J, Epstein A, Kelsen D, Chalasani S, Keane F, Schoenfeld J, Singhal A, Diguglielmo E, Bandlamudi C, Song J, Ozkan HS, Hong J, Zhang H, Cardenas A, Lao M, Melchor J, Shah R, Kang W, Mazzoni F, Soares K, Donoghue M, Balachandran V, Schattner M, Santos E, Rolston V, Reyngold M, Wei A, Homsi R, Tipping M, Basturk O, Berger M, Do R, Jarnagin W, Riaz N, Pe'er D, Capanu M, Iacobuzio-Donahue C, O'Reilly E. Pembrolizumab and Olaparib (POLAR) Maintenance Therapy in Metastatic Pancreatic Cancer With or Without Homologous Repair Deficiency: A Biomarker Selected Phase II Trial. Res Sq [Preprint]. 2025 Sep 1:rs.3.rs-7334701. doi: 10.21203/rs.3.rs-7334701/v1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olaparib | Small molecule | 300 mg | Oral |
| Subject | Pembrolizumab | Monoclonal antibody | 400 mg | Intravenous |