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NCT03723915 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab and Pelareorep in Treating Patients With Advanced Pancreatic Cancer
A Phase 2 study, sponsored by Northwestern University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT03723915: Clinical Trial Phase 2 study, sponsored by Northwestern University.
NCT03723915 is a Phase 2 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03723915, a Phase 2 study, was terminated before completion, sponsored by Northwestern University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
This phase II trial studies the side effects and how well pembrolizumab in combination with pelareorep work in treating patients with pancreatic cancer that has spread to other parts of the body. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. A virus, called reovirus (pelareorep), which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells. Giving pembrolizumab in combination with pelareorep may work better in treating patients with advanced pancreatic cancer.
Primary Outcome
To determine the overall response rate (ORR) by RECIST v 1.1 criteria for the combination of pembrolizumab with pelareorep. ORR is defined as the number of patients who have a complete or partial response to therapy (CR or PR). The Simon 2 stage design for this study requires 2 or more PR or CR in Stage 1 to continue accrual for Stage 2. Per RECIST v. 1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL Wild-type Reovirus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2018-11-14 |
| Est. Completion | 2021-04-24 |
| Phase | Phase 2 |
Why NCT03723915 stopped before completion
NCT03723915 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03723915 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03723915 about?
NCT03723915 is a clinical study titled "Pembrolizumab and Pelareorep in Treating Patients With Advanced Pancreatic Cancer". This phase II trial studies the side effects and how well pembrolizumab in combination with pelareorep work in treating patients with pancreatic cancer that has spread to other parts of the body. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may induce changes in the body's immune...
What is the current status of trial NCT03723915?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2018-11-14. Estimated completion is 2021-04-24.
What interventions are being tested in trial NCT03723915?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Wild-type Reovirus (BIOLOGICAL).
Who is sponsoring clinical trial NCT03723915?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03723915's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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