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NCT01675765 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Listeria in Combination With Chemotherapy as Front-line Treatment for Malignant Pleural Mesothelioma
A Phase 1 study, sponsored by Aduro Biotech.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT01675765: Completed Phase 1 study, sponsored by Aduro Biotech.
NCT01675765 is a Phase 1 study that has completed, run by Aduro Biotech. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01675765, a Phase 1 study, has completed, sponsored by Aduro Biotech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
This clinical trial will evaluate the safety and immune response of the sequential administration cancer vaccine CRS-207 (with or without cyclophosphamide) followed by standard of care chemotherapy (pemetrexed and cisplatin). CRS-207 is a weakened (attenuated) form of Listeria monocytogenes that has been genetically-modified to reduce its capacity to cause disease, while maintaining its ability to stimulate potent immune responses. CRS-207 has been engineered to elicit an immune response against the tumor-associated antigen mesothelin, which has been shown to be present at higher levels on certain tumor cells (such as mesothelioma) than on normal cells. Pemetrexed and cisplatin are the standard chemotherapy regimen to treat malignant pleural mesothelioma. This trial will evaluate whether giving CRS-207 cancer vaccine with chemotherapy will induce anti-tumor immune responses and/or objective tumor response.
Primary Outcome
Count of subjects with incidences of adverse events.
Interventions
- BIOLOGICAL Immunotherapy plus chemotherapy
- BIOLOGICAL Immunotherapy with cyclophosphamide plus chemotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2014-09-03 |
| Est. Completion | 2019-08-19 |
| Phase | Phase 1 |
What the finished NCT01675765 record still lists
NCT01675765 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Immunotherapy plus chemotherapy is the first listed.
NCT01675765 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01675765 about?
NCT01675765 is a clinical study titled "Safety and Efficacy of Listeria in Combination With Chemotherapy as Front-line Treatment for Malignant Pleural Mesothelioma". This clinical trial will evaluate the safety and immune response of the sequential administration cancer vaccine CRS-207 (with or without cyclophosphamide) followed by standard of care chemotherapy (pemetrexed and cisplatin). CRS-207 is a weakened (attenuated) form of Listeria monocytogenes that has...
What is the current status of trial NCT01675765?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2014-09-03. Estimated completion is 2019-08-19.
What interventions are being tested in trial NCT01675765?
The interventions under investigation include: Immunotherapy plus chemotherapy (BIOLOGICAL), Immunotherapy with cyclophosphamide plus chemotherapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT01675765?
This trial is sponsored by Aduro Biotech, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01675765's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 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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