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NCT04548752 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 88
- Enrollment target
- 20
- Study locations
NCT04548752: Active Phase 2 study of Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
NCT04548752 is a Phase 2 study of Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 88 participants, roughly in line with the 88-participant average among 37 other Metastatic Pancreatic Adenocarcinoma trials with a reported enrollment target. The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04548752, a Phase 2 study of Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 88 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Primary analysis of PFS will be conducted in all eligible patients according to the intent-to-treat principle using a log rank test stratified by first line chemotherapy, performance status and disease status after first line platinum-based treatment. Distributions of PFS by treatment arm will be estimated using the method of Kaplan-Meier.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Biopsy Procedure
- DRUG Olaparib
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
California
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- PCR Oncology - Arroyo Grande
- Sutter Auburn Faith Hospital - Auburn
- Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
Arizona
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2021-02-22 |
| Est. Completion | 2026-10-01 |
| Phase | Phase 2 |
What the registry record for NCT04548752 still lists
NCT04548752 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, roughly in line with the 88-participant average among 37 other Metastatic Pancreatic Adenocarcinoma trials with a reported enrollment target.
The record links to 2 conditions, with Metastatic Pancreatic Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04548752 names 20 study sites across 4 states, led by Alaska, California, Arkansas.
Frequently Asked Questions
What is clinical trial NCT04548752 about?
NCT04548752 is a clinical study titled "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". 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 p...
What is the current status of trial NCT04548752?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2021-02-22. Estimated completion is 2026-10-01.
What conditions does trial NCT04548752 study?
This clinical trial studies the following conditions: Metastatic Pancreatic Adenocarcinoma, Stage IV Pancreatic Cancer AJCC v8.
What interventions are being tested in trial NCT04548752?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Biopsy Procedure (PROCEDURE), Olaparib (DRUG).
Who is sponsoring clinical trial NCT04548752?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04548752 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04548752's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Pancreatic Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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