Combination Immunotherapy in Biochemically Recurrent Prostate Cancer
Public ClinicalTrials.gov record NCT03315871. 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 II Trial of Combination Immunotherapy in Biochemically Recurrent Prostate Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Background: Some people with prostate cancer have a rise in prostate-specific antigen (PSA). This can happen even after treatments like radiation and surgery. Androgen deprivation therapy (ADT) drugs and close monitoring are one standard way to treat this group of people. Another way is to monitor people and their PSA values over time. Researchers want to see if a combination of new drugs can help these people. Objective: To see if the combination treatment of PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec vaccinia), CV301, and MSB0011359C (M7824) can induce an anti-tumor impact in people with biochemically recurrent prostate cancer. Eligibility: People ages 18 and older with certain kinds of prostate cancer Design: Participants will be screened with * Medical history * Physical exam * Blood and urine tests * A scan of the neck, chest, abdomen, and pelvis * A bone scan A sample of tissue that was already taken will be tested. This will confirm the diagnosis, stage, and disease status. Some participants will have close monitoring with four monthly PSA checks. All participants will get two study drugs as shots under the skin. They will get the third drug in a vein. They will get the drugs over at least 7 months. Their vital signs will be checked before they get the drugs and for up to 1 hour after. Participants will have frequent study visits. They will have physical exams, urine and blood tests, and scans. Participants will return to the clinic about 4 weeks after they stop taking the study drugs. They will have a medical history, physical exam, and blood tests. They may also have long-term follow-up visits.
Study identification
- NCT ID
- NCT03315871
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 40 participants
Conditions and interventions
Conditions
Interventions
- Antigen direct immunotherapy: PROSTVAC-V Biological
- Antigen direct immunotherapy: PROSTVAC-F Biological
- MSB0011359C (M7824) Drug
- Antigen direct immunotherapy: CV301 Biological
- CT scan of chest Diagnostic Test
- CT scan of abdomen/pelvis Diagnostic Test
- MRI Diagnostic Test
- PSMA Diagnostic Test
- Bone scan Diagnostic Test
Biological · Drug · Diagnostic Test
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Mar 19, 2018
- Primary completion
- Jun 3, 2024
- Completion
- Jun 3, 2024
- Last update posted
- Jun 18, 2025
2018 – 2024
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 NCT03315871, 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 Jun 18, 2025 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03315871 live on ClinicalTrials.gov.