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NCT03153410 · ClinicalTrials.gov registry record · Early Phase 1
Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas
A Early Phase 1 study of Pancreatic Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT03153410: Completed Early Phase 1 study of Pancreatic Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT03153410 is a Early Phase 1 study of Pancreatic Cancer that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 11 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03153410, a Early Phase 1 study of Pancreatic Cancer, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate whether combining cyclophosphamide (CY), pembrolizumab, GVAX and IMC-CS4 is effective and safe in patients with borderline resectable pancreatic cancer.
Primary Outcome
Treatment-related immunologic effect is defined as an 80% or greater increase in the number of CD8+ T cells (and at least 1.8 times the baseline median absolute deviation) in surgically resected tumor tissue in comparison to the baseline biopsy in subjects that received at least 1 dose of neoadjuvant combination immunotherapy and underwent a R0, R1, or R2 surgical resection.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Cyclophosphamide
- DRUG GVAX Pancreas Vaccine (GVAX)
- DRUG IMC-CS4
Study Locations (1)
Maryland
- Sidney Kimmel Comprehensive Cancer Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2018-09-27 |
| Est. Completion | 2023-08-29 |
| Phase | Early Phase 1 |
What the finished NCT03153410 record still lists
NCT03153410 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Pancreatic Cancer appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT03153410 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03153410 about?
NCT03153410 is a clinical study titled "Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas". The purpose of this study is to evaluate whether combining cyclophosphamide (CY), pembrolizumab, GVAX and IMC-CS4 is effective and safe in patients with borderline resectable pancreatic cancer.
What is the current status of trial NCT03153410?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 11 participants. The study started on 2018-09-27. Estimated completion is 2023-08-29.
What conditions does trial NCT03153410 study?
This clinical trial studies the following conditions: Pancreatic Cancer.
What interventions are being tested in trial NCT03153410?
The interventions under investigation include: Pembrolizumab (DRUG), Cyclophosphamide (DRUG), GVAX Pancreas Vaccine (GVAX) (DRUG), IMC-CS4 (DRUG).
Who is sponsoring clinical trial NCT03153410?
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 NCT03153410 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 NCT03153410's enrollment target sits among peer trials
11 261st of 278 higher than 17 of 278 other Pancreatic Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Cancer 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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