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Testing the Addition of Pembrolizumab, an Immunotherapy Cancer Drug to Olaparib Alone as Therapy for Patients With Pancreatic Cancer That Has Spread With Inherited BRCA Mutations

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 539 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Final enrollment: 68 participants (planned 88) Primary completion date changed from estimate of Oct 1, 2026 to Jul 16, 2025 · Completion pushed from Oct 1, 2026 to Oct 5, 2027 Show 2 more changesShow less
    • Primary completion date changed from estimate of Oct 1, 2026 to Jul 16, 2025
    • Completion pushed from Oct 1, 2026 to Oct 5, 2027
  2. Minor Re-verified, no change to tracked fields
  3. Minor Site details revised at 33 of 533 sites
  4. Minor Study sites: 534 to 533v536
  5. Minor Study sites revised (534)v535 See this version in full on ClinicalTrials.gov ↗
Show 45 earlier versionsHide 45 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv534
  2. Minor Study sites: 535 to 534v533
  3. Minor Study sites revised (535)v532 See this version in full on ClinicalTrials.gov ↗
  4. Minor Re-verified, no change to tracked fieldsv531
  5. Minor Study sites: 536 to 535v530
  6. Minor 40 versions Re-verified since Feb 12, 2026, no change to tracked fieldsv490-v529
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase II trial studies whether adding pembrolizumab to olaparib (standard of care) works better than olaparib alone in treating patients with pancreatic cancer with germline BRCA1 or BRCA2 mutations that has spread to other places in the body (metastatic). BRCA1 and BRCA2 are human genes that produce tumor suppressor proteins. These proteins help repair damaged deoxyribonucleic acid (DNA) and, therefore, play a role in ensuring the stability of each cell's genetic material. When either of these genes is mutated, or altered, such that its protein product is not made or does not function correctly, DNA damage may not be repaired properly. As a result, cells are more likely to develop additional genetic alterations that can lead to some types of cancer, including pancreatic cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Olaparib is an inhibitor of PARP, a protein that helps repair damaged DNA. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. The addition of pembrolizumab to the usual treatment of olaparib may help to shrink tumors in patients with metastatic pancreatic cancer with BRCA1 or BRCA2 mutations.
Trial Details
NCT Number NCT04548752
Lead Sponsor National Cancer Institute (NCI)
Conditions Metastatic Pancreatic Adenocarcinoma, Stage IV Pancreatic Cancer AJCC v8
Enrollment 68 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov