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NCT03264404 · ClinicalTrials.gov registry record · Phase 2
Azacitidine and Pembrolizumab in Pancreatic Cancer
A Phase 2 study, sponsored by Susan E. Bates.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT03264404: Completed Phase 2 study, sponsored by Susan E. Bates.
NCT03264404 is a Phase 2 study that has completed, run by Susan E. Bates. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03264404, a Phase 2 study, has completed, sponsored by Susan E. Bates.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the effectiveness of combining immune therapy, pembrolizumab, with a hypomethylating agent, azacitidine, for pancreatic cancer. People who have advanced pancreatic cancer with disease progression on first-line therapy are usually treated with a second chemotherapy regimen. However, there is no single accepted chemotherapy regimen and national guidelines recommend chemotherapy or clinical trial participation. In this study, all study subjects will receive a combination of immune therapy (every 3 weeks) and a hypomethylating agent (every 4 weeks). To date, studies have shown that combining a hypomethylating agent with chemotherapy or immune therapy may benefit patients across different solid tumor types including pancreatic cancer. Preclinical data in a mouse model of pancreatic cancer demonstrates improvement in survival with the combination of a hypomethylating agent and immune therapy. However, the use of single agent hypomethylating agent or immune therapy has not been shown to be effective in patients with pancreatic cancer. The one exception, to date, is the use of immune therapy in those individuals with a particular genetic feature known as mismatch repair deficiency and microsatellite instability. The combination of immune therapy and a hypomethylating agent has not been studied in human subjects and is not approved by the FDA for use in pancreatic cancer. This is a non-randomized, single-center, open-label trial of pembrolizumab and azacitidine in subjects with locally advanced or metastatic pancreatic adenocarcinoma. Approximately 31 individuals will be asked to participate in this study.
Primary Outcome
PFS is defined as the time from the first day of trial treatment to the first documented disease progression per RECIST 1.1 (At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressi
Interventions
- DRUG Pembrolizumab
- DRUG Azacitidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2017-10-01 |
| Est. Completion | 2024-12-03 |
| Phase | Phase 2 |
What the finished NCT03264404 record still lists
NCT03264404 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03264404 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03264404 about?
NCT03264404 is a clinical study titled "Azacitidine and Pembrolizumab in Pancreatic Cancer". The purpose of this study is to determine the effectiveness of combining immune therapy, pembrolizumab, with a hypomethylating agent, azacitidine, for pancreatic cancer. People who have advanced pancreatic cancer with disease progression on first-line therapy are usually treated with a second chemot...
What is the current status of trial NCT03264404?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2017-10-01. Estimated completion is 2024-12-03.
What interventions are being tested in trial NCT03264404?
The interventions under investigation include: Pembrolizumab (DRUG), Azacitidine (DRUG).
Who is sponsoring clinical trial NCT03264404?
This trial is sponsored by Susan E. Bates, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03264404's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 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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