{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":null,"indication":"prostate cancer","name":"NCT02933255","nct_id":"NCT02933255","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct02933255. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Prostate-specific antigen (PSA)-TRICOM vaccinia (PROSTVAC)-V on week 0 followed by booster injection called PROSTVAC-F on week 2, 4, and 8. Nivolumab will be administered on week 2, 4, 6, 8 and 10. When administered on the same day, the preferred order of administration is PROSTVAC first followed by nivolumab. Participants will undergo restaging scans on week 12. If no progressive disease (PD), option to continue treatment with nivolumab every 2 weeks and PROSTVAC-F every 4 weeks until intolerance or progression. Option to extend nivolumab interval to 4 weeks for participants who remain on protocol beyond 1 year.","label":"Lead-in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Cohort","type":"EXPERIMENTAL"},{"description":"Prostate-specific antigen (PSA)-TRICOM vaccinia (PROSTVAC)-V on week 0 followed by booster injection called PROSTVAC-fowlpox (F) on 2, 4 and 8 weeks. Nivolumab will be administered on week 2, 4, and 8. When administered on the same day, the preferred order of administration is PROSTVAC first followed by nivolumab. Participants will undergo prostatectomy on week 9.","label":"Neoadjuvant Cohort","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2023-12-01","type":"ACTUAL"},"conditions":["Prostate Cancer"],"enrollment":{"count":24,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"PROSTVAC-V/F","otherNames":["Prostate-specific antigen (PSA)-TRICOM vaccinia fowlpox (PROSTVAC-V/F)"],"type":"BIOLOGICAL"},{"name":"Nivolumab","otherNames":["Opdivo"],"type":"DRUG"},{"name":"Prostatectomy","otherNames":[],"type":"PROCEDURE"},{"name":"Biopsy","otherNames":[],"type":"PROCEDURE"},{"name":"Tylenol","otherNames":["Acetaminophen"],"type":"DRUG"}],"last_update":"2024-05-31","lead_sponsor":"National Cancer Institute (NCI)","official_title":"Phase I/II Study of PROSTVAC in Combination With Nivolumab in Men With Prostate Cancer","overall_status":"COMPLETED","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2023-06-20","type":"ACTUAL"},"primary_outcomes":[{"measure":"Number of Participants With Clinically Important Immune-related Adverse Events (for the Lead-In Cohort)","timeFrame":"From treatment start throughout study completion, an average of 1.4 years."},{"measure":"Changes in T-cell Infiltration in the Tumor After Neoadjuvant Treatment (Only for the Neoadjuvant Cohort)","timeFrame":"From baseline to radical prostatectomy (approximately week 9)"}],"references":[{"citation":"Lassoued W, Madan RA, Xue E, Burnett D, Canubas KD, Bailey S, Marte JL, Tsai YT, Donahue RN, Turkbey IB, Papanicolau-Sengo A, Williams M, Hankin A, Manukyan M, Manu M, Kang Z, Pritchard C, Dahut W, Karzai F, Schlom J, Sater S, Pinto P, Gulley JL. Programmed death-1 inhibition increases vaccine-induced T-cell infiltration in patients with prostate cancer. J Immunother Cancer. 2025 Jun 22;13(6):e010851. doi: 10.1136/jitc-2024-010851.","pmid":"40550568","type":"DERIVED"}],"start_date":{"date":"2017-04-18","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"PROSTVAC in Combination With Nivolumab in Men With Prostate Cancer","url":"https://clinicaltrials.gov/study/NCT02933255"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct02933255"}