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NCT03006302 · ClinicalTrials.gov registry record · Phase 2
Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer
A Phase 2 study of Metastatic Pancreatic Adenocarcinoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
- 1
- Study location
NCT03006302: Completed Phase 2 study of Metastatic Pancreatic Adenocarcinoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT03006302 is a Phase 2 study of Metastatic Pancreatic Adenocarcinoma that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 41 participants, below the 89-participant average among 37 other Metastatic Pancreatic Adenocarcinoma trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03006302, a Phase 2 study of Metastatic Pancreatic Adenocarcinoma, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will enroll patients who have metastatic pancreatic cancer and have progressed on prior chemotherapy. Part 1 (dose escalation) participants will receive epacadostat/pembrolizumab/cyclophosphamide(CY)/GVAX pancreas vaccine followed by epacadostat/pembrolizumab/CRS-207, Part 1X (dose escalation) participants will receive epacadostat/pembrolizumab/CRS-207. Part 2X (dose expansion) participants will receive epacadostat/pembrolizumab/CRS-207. The primary objectives of this study are to determine the recommended dose of epacadostat in this combination and assess survival of subjects in both treatment groups.
Primary Outcome
Dose escalation (part I of the trial only) to determine the maximum tolerated dose (MTD) in mg BID. Epacadostat (100, 300, or 600 mg) was taken by mouth twice a day, every day.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Cyclophosphamide
- DRUG Epacadostat
- BIOLOGICAL GVAX Pancreas Vaccine
- BIOLOGICAL CRS-207
Study Locations (1)
Maryland
- The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2018-01-31 |
| Est. Completion | 2024-08-05 |
| Phase | Phase 2 |
What the finished NCT03006302 record still lists
NCT03006302 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 89-participant average among 37 other Metastatic Pancreatic Adenocarcinoma trials with a reported enrollment target (54% lower).
The record links to 1 condition, with Metastatic Pancreatic Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03006302 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03006302 about?
NCT03006302 is a clinical study titled "Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer". This study will enroll patients who have metastatic pancreatic cancer and have progressed on prior chemotherapy. Part 1 (dose escalation) participants will receive epacadostat/pembrolizumab/cyclophosphamide(CY)/GVAX pancreas vaccine followed by epacadostat/pembrolizumab/CRS-207, Part 1X (dose escal...
What is the current status of trial NCT03006302?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2018-01-31. Estimated completion is 2024-08-05.
What conditions does trial NCT03006302 study?
This clinical trial studies the following conditions: Metastatic Pancreatic Adenocarcinoma.
What interventions are being tested in trial NCT03006302?
The interventions under investigation include: Pembrolizumab (DRUG), Cyclophosphamide (DRUG), Epacadostat (DRUG), GVAX Pancreas Vaccine (BIOLOGICAL), CRS-207 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03006302?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03006302 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03006302's enrollment target sits among peer trials
41 22nd of 37 higher than 16 of 37 other Metastatic Pancreatic Adenocarcinoma trials
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.
Source ClinicalTrials.gov registry export · 2026-08-08
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