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NCT03376659 · ClinicalTrials.gov registry record · Phase 1
Durvalumab Plus CV301 With Maintenance Chemotherapy in Metastatic Colorectal or Pancreatic Adenocarcinoma
A Phase 1 study, sponsored by Georgetown University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT03376659: Clinical Trial Phase 1 study, sponsored by Georgetown University.
NCT03376659 is a Phase 1 study that was terminated before completion, run by Georgetown University. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03376659, a Phase 1 study, was terminated before completion, sponsored by Georgetown University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This is a dual arm, open label phase I/II study to evaluate the safety and clinical activity of the combination of durvalumab with CV301 in combination with maintenance chemotherapy for patients with metastatic colorectal or pancreatic cancer whose disease is stable on, or responding to 1st line therapy for metastatic disease. Patients with metastatic colorectal or pancreatic adenocarcinoma who still have an adequate performance status and normal hepatic and renal function will be eligible.
Primary Outcome
The Recommended Phase II dose of durvalumab in the combination of durvalumab plus CV301 with maintenance chemotherapy as determined by the Phase I design
Interventions
- DRUG Bevacizumab
- DRUG Capecitabine
- DRUG Durvalumab
- BIOLOGICAL CV301
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2018-08-08 |
| Est. Completion | 2023-08-01 |
| Phase | Phase 1 |
Why NCT03376659 stopped before completion
NCT03376659 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 4 interventions - of which Bevacizumab is the first listed.
NCT03376659 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03376659 about?
NCT03376659 is a clinical study titled "Durvalumab Plus CV301 With Maintenance Chemotherapy in Metastatic Colorectal or Pancreatic Adenocarcinoma". This is a dual arm, open label phase I/II study to evaluate the safety and clinical activity of the combination of durvalumab with CV301 in combination with maintenance chemotherapy for patients with metastatic colorectal or pancreatic cancer whose disease is stable on, or responding to 1st line the...
What is the current status of trial NCT03376659?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2018-08-08. Estimated completion is 2023-08-01.
What interventions are being tested in trial NCT03376659?
The interventions under investigation include: Bevacizumab (DRUG), Capecitabine (DRUG), Durvalumab (DRUG), CV301 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03376659?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03376659's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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