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NCT03600350 · ClinicalTrials.gov registry record · Phase 2
pTVG-HP and Nivolumab in Patients With Non-Metastatic PSA-Recurrent Prostate Cancer
A Phase 2 study of Prostate Cancer, sponsored by University of Wisconsin, Madison.
- Active
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT03600350: Active Phase 2 study of Prostate Cancer, sponsored by University of Wisconsin, Madison.
NCT03600350 is a Phase 2 study of Prostate Cancer that is active but no longer recruiting, run by University of Wisconsin, Madison. The registered enrollment target is 19 participants, below the 608-participant average among 735 other Prostate 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
NCT03600350, a Phase 2 study of Prostate Cancer, is active but no longer recruiting, sponsored by University of Wisconsin, Madison.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the safety of an investigational DNA vaccine, pTVG-HP, a plasmid DNA encoding human prostatic acid phosphatase (PAP), in combination with nivolumab, and the efficacy of this combination in decreasing serum Prostate-Specific Antigen (PSA) in patients with non-metastatic, non-castrate prostate cancer (clinical stage D0/M0).
Primary Outcome
Subjects will be evaluated at each visit by a review of systems based on the most recent version of the NCI common toxicity criteria. Safety and Tolerability of this intervention is defined as following: a toxicity rate p0 of at most 15% of Grade ≥ 3 toxicity events (CTCAE v.4.0) will be considered as acceptable while a toxicity rate p1=35% or more will be considered as unacceptably high. See Adverse Events Section for full summary of data.
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG GM-CSF
- BIOLOGICAL pTVG-HP
Study Locations (1)
Wisconsin
- University of Wisconsin Carbone Cancer Center - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2018-09-10 |
| Est. Completion | 2027-12 |
| Phase | Phase 2 |
What the registry record for NCT03600350 still lists
NCT03600350 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT03600350 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT03600350 about?
NCT03600350 is a clinical study titled "pTVG-HP and Nivolumab in Patients With Non-Metastatic PSA-Recurrent Prostate Cancer". The purpose of this study is to evaluate the safety of an investigational DNA vaccine, pTVG-HP, a plasmid DNA encoding human prostatic acid phosphatase (PAP), in combination with nivolumab, and the efficacy of this combination in decreasing serum Prostate-Specific Antigen (PSA) in patients with non-...
What is the current status of trial NCT03600350?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2018-09-10. Estimated completion is 2027-12.
What conditions does trial NCT03600350 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT03600350?
The interventions under investigation include: Nivolumab (DRUG), GM-CSF (DRUG), pTVG-HP (BIOLOGICAL).
Who is sponsoring clinical trial NCT03600350?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03600350 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
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 NCT03600350's enrollment target sits among peer trials
19 668th of 735 higher than 62 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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