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NCT02325557 · ClinicalTrials.gov registry record · Phase 1
ADXS31-142 Alone and in Combination With Pembrolizumab (MK-3475) in Participants With Previously Treated Metastatic Castration-Resistant Prostate Cancer (mCRPC)
A Phase 1 study of Prostate Cancer and Cancer, sponsored by Advaxis.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 8
- Study locations
NCT02325557: Completed Phase 1 study of Prostate Cancer and Cancer, sponsored by Advaxis.
NCT02325557 is a Phase 1 study of Prostate Cancer and Cancer that has completed, run by Advaxis. The registered enrollment target is 50 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (92% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02325557, a Phase 1 study of Prostate Cancer and Cancer, has completed, sponsored by Advaxis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 8
- Study locations
Study Summary
A Phase 1/2 multicenter, dose determining, open-label study of ADXS31-142 monotherapy and a combination of ADXS31-142 and pembrolizumab (MK-3475) in participants with metastatic castration-resistant prostate cancer. Part A will be dose-determining part of ADXS31-142 monotherapy. Part B will be dose-determining part of ADXS31-142 and pembrolizumab (MK-3475) in combination. Part B expansion will treat additional participants with the recommended dose from Part B.
Primary Outcome
An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considere
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG ADXS31-142
Study Locations (8)
Maryland
- Recruiting - Rockville
- Recruiting - Towson
Pennsylvania
- Recrutiing - Philadelphia
- Site - Philadelphia
California
- Recruiting - San Francisco
Colorado
- University of Colorado Health Sciences Center (UCHSC) - Aurora
New Jersey
- - New Brunswick
Rhode Island
- Recruiting - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2015-06-04 |
| Est. Completion | 2020-01-22 |
| Phase | Phase 1 |
What the finished NCT02325557 record still lists
NCT02325557 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT02325557 lists 8 locations in 6 states (Maryland, Pennsylvania, California).
Frequently Asked Questions
What is clinical trial NCT02325557 about?
NCT02325557 is a clinical study titled "ADXS31-142 Alone and in Combination With Pembrolizumab (MK-3475) in Participants With Previously Treated Metastatic Castration-Resistant Prostate Cancer (mCRPC)". A Phase 1/2 multicenter, dose determining, open-label study of ADXS31-142 monotherapy and a combination of ADXS31-142 and pembrolizumab (MK-3475) in participants with metastatic castration-resistant prostate cancer. Part A will be dose-determining part of ADXS31-142 monotherapy. Part B will be dose-...
What is the current status of trial NCT02325557?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2015-06-04. Estimated completion is 2020-01-22.
What conditions does trial NCT02325557 study?
This clinical trial studies the following conditions: Prostate Cancer, Cancer.
What interventions are being tested in trial NCT02325557?
The interventions under investigation include: Pembrolizumab (DRUG), ADXS31-142 (DRUG).
Who is sponsoring clinical trial NCT02325557?
This trial is sponsored by Advaxis, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02325557 being conducted?
This trial has 8 study locations across California, Colorado, Maryland, New Jersey, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02325557's enrollment target sits among peer trials
50 469th of 735 higher than 247 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate 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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