PROSTVAC in Combination With Nivolumab in Men With Prostate Cancer
Public ClinicalTrials.gov record NCT02933255. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase I/II Study of PROSTVAC in Combination With Nivolumab in Men With Prostate Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02933255
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 24 participants
Conditions and interventions
Conditions
Interventions
- PROSTVAC-V/F Biological
- Nivolumab Drug
- Prostatectomy Procedure
- Biopsy Procedure
- Tylenol Drug
Biological · Drug · Procedure
Eligibility (public fields only)
- Age range
- 18 Years to 120 Years
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 17, 2017
- Primary completion
- Jun 19, 2023
- Completion
- Nov 30, 2023
- Last update posted
- May 30, 2024
2017 – 2023
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02933255, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 30, 2024 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02933255 live on ClinicalTrials.gov.