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NCT04493060 · ClinicalTrials.gov registry record · Phase 2
Niraparib and Dostarlimab for the Treatment of Germline or Somatic BRCA1/2 and PALB2 Mutated Metastatic Pancreatic Cancer
A Phase 2 study of Stage IV Pancreatic Cancer AJCC v8 and Metastatic Pancreatic Ductal Adenocarcinoma, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
- 3
- Study locations
NCT04493060: Completed Phase 2 study of Stage IV Pancreatic Cancer AJCC v8 and Metastatic Pancreatic Ductal Adenocarcinoma, sponsored by Mayo Clinic.
NCT04493060 is a Phase 2 study of Stage IV Pancreatic Cancer AJCC v8 and Metastatic Pancreatic Ductal Adenocarcinoma that has completed, run by Mayo Clinic. The registered enrollment target is 22 participants, below the 88-participant average among 31 other Stage IV Pancreatic Cancer AJCC v8 trials with a reported enrollment target (75% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04493060, a Phase 2 study of Stage IV Pancreatic Cancer AJCC v8 and Metastatic Pancreatic Ductal Adenocarcinoma, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase II trial studies how well niraparib and dostarlimab work in treating patients with germline or somatic BRCA1/2 and PALB2 mutated pancreatic cancer that has spread to other places in the body (metastatic). Niraparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as dostarlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving niraparib and dostarlimab may kill more tumor cells.
Primary Outcome
Will be assessed using the standard immune-modified Response Evaluation Criteria in Solid Tumors (iRECIST) criteria.
Conditions Studied
Interventions
- DRUG Niraparib
- BIOLOGICAL Dostarlimab
Study Locations (3)
Arizona
- Mayo Clinic in Arizona - Scottsdale
Florida
- Mayo Clinic in Florida - Jacksonville
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2020-12-28 |
| Est. Completion | 2025-06-01 |
| Phase | Phase 2 |
What the finished NCT04493060 record still lists
NCT04493060 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 88-participant average among 31 other Stage IV Pancreatic Cancer AJCC v8 trials with a reported enrollment target (75% lower).
The record links to 2 conditions, with Stage IV Pancreatic Cancer AJCC v8 appearing as the primary indexed condition, and to 2 interventions - of which Niraparib is the first listed.
NCT04493060 reports a single indexed study location in Arizona, Florida, Minnesota.
Frequently Asked Questions
What is clinical trial NCT04493060 about?
NCT04493060 is a clinical study titled "Niraparib and Dostarlimab for the Treatment of Germline or Somatic BRCA1/2 and PALB2 Mutated Metastatic Pancreatic Cancer". This phase II trial studies how well niraparib and dostarlimab work in treating patients with germline or somatic BRCA1/2 and PALB2 mutated pancreatic cancer that has spread to other places in the body (metastatic). Niraparib may stop the growth of tumor cells by blocking some of the enzymes needed ...
What is the current status of trial NCT04493060?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2020-12-28. Estimated completion is 2025-06-01.
What conditions does trial NCT04493060 study?
This clinical trial studies the following conditions: Stage IV Pancreatic Cancer AJCC v8, Metastatic Pancreatic Ductal Adenocarcinoma.
What interventions are being tested in trial NCT04493060?
The interventions under investigation include: Niraparib (DRUG), Dostarlimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04493060?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04493060 being conducted?
This trial has 3 study locations across Arizona, Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04493060's enrollment target sits among peer trials
22 25th of 31 higher than 7 of 31 other Stage IV Pancreatic Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Pancreatic Cancer AJCC v8 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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