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NCT02933255 · ClinicalTrials.gov registry record · Phase 1
PROSTVAC in Combination With Nivolumab in Men With Prostate Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT02933255: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT02933255 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02933255, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Background: The immune system is the cells and organs in the body that recognize and fight infection and cancer. The prostate specific antigen (PSA)/TRICOM (PROSTVAC) vaccine might teach the immune system to find and kill certain prostate cancer cells. Nivolumab is a drug that allows the immune system to fight tumors. It might help PROSTVAC work better. Objective: To test the safety and effectiveness of the combination of PROSTVAC and nivolumab. To test this for people with castration resistant prostate cancer and then for other people with localized prostate cancer who are candidates for surgical removal of the prostate. Eligibility: Men ages 18 and older with prostate cancer Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Electrocardiogram Bone scan Computed tomography (CT) scan or magnetic resonance imaging (MRI) Tumor sample. This may be from a previous procedure. All participants will get a combination of the study drugs over 8 weeks. They will have 1 visit for the initial injection then 3 booster injection / nivolumab infusion visits. Blood will be tested at these visits. Over the next 4 weeks, some participants will have: An exam of the large intestine through the rectum. CT and bone scans Standard hormonal treatment Option to continue treatment every 3 weeks if their disease does not get worse. They will have scans every 12 weeks. Other participants will have surgery to remove the prostate in week 9. Participants will have a safety visit about a month after their last treatment. This will include a physical exam, blood tests, and possibly scans. If their cancer progresses, participants will leave the study and may enroll in a long-term follow-up study. They will be contacted once a year to ask about their cancer and treatment.
Primary Outcome
Clinically important immune-related adverse events were defined as grade 3 or above inflammation requiring steroids or anti cytokine therapy or not resolving to grade 1 or less within 28 days. These immune-related adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 3 is severe, grade 4 is life-threatening, and grade 5 is death related to adverse event.
Interventions
- PROCEDURE Biopsy
- DRUG Nivolumab
- DRUG Tylenol
- PROCEDURE Prostatectomy
- BIOLOGICAL PROSTVAC-V/F
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2017-04-18 |
| Est. Completion | 2023-12-01 |
| Phase | Phase 1 |
What the finished NCT02933255 record still lists
NCT02933255 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 5 interventions - of which Biopsy is the first listed.
NCT02933255 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02933255 about?
NCT02933255 is a clinical study titled "PROSTVAC in Combination With Nivolumab in Men With Prostate Cancer". Background: The immune system is the cells and organs in the body that recognize and fight infection and cancer. The prostate specific antigen (PSA)/TRICOM (PROSTVAC) vaccine might teach the immune system to find and kill certain prostate cancer cells. Nivolumab is a drug that allows the immune sys...
What is the current status of trial NCT02933255?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2017-04-18. Estimated completion is 2023-12-01.
What interventions are being tested in trial NCT02933255?
The interventions under investigation include: Biopsy (PROCEDURE), Nivolumab (DRUG), Tylenol (DRUG), Prostatectomy (PROCEDURE), PROSTVAC-V/F (BIOLOGICAL).
Who is sponsoring clinical trial NCT02933255?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02933255's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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