{"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":[["testosterone","nivolumab"]],"indication":"metastatic castration-resistant prostate cancer","name":"COMBAT-CRPC","nct_id":"NCT03554317","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=combat-crpc-nct03554317. 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":"COMBAT-CRPC","arms":[{"description":"All participants must have a rising PSA and/or radiographic progression and prior treatment with at least one novel androgen receptor (AR) targeted therapy (i.e. abiraterone acetate, enzalutamide). Up to one taxane agent for metastatic castration-resistant prostate cancer is permitted. Patients will be treated with testosterone cypionate 400mg IM every 4 weeks for a lead-in period of 12 weeks. After the lead-in period, all patients will be treated with nivolumab 480mg IV every 4 weeks and maintained on testosterone cypionate 400mg IM every 4 weeks. Treatment \\[with a minimum drug exposure of 12 weeks\\] will be continued until PSA progression (PCGW3 criteria) or clinical/radiographic progression (whichever comes first), or until unmanageable toxicity requiring drug cessation.","label":"Bipolar Androgen Therapy + Nivolumab","type":"EXPERIMENTAL"}],"collaborators":["Bristol-Myers Squibb"],"completion_date":{"date":"2023-01-06","type":"ACTUAL"},"conditions":["Castration-resistant Prostate Cancer","Metastatic Prostate Cancer","Prostate Cancer"],"enrollment":{"count":45,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Testosterone cypionate","otherNames":["Depot (DEPO)-Testosterone Injection"],"type":"DRUG"},{"name":"Nivolumab","otherNames":["BMS-936558","MDX1106","ONO-4538"],"type":"DRUG"}],"last_update":"2024-02-20","lead_sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","official_title":"COMbination of Bipolar Androgen Therapy and Nivolumab in Patients With Metastatic Castration-Resistant Prostate Cancer","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2022-10-27","type":"ACTUAL"},"primary_outcomes":[{"measure":"Prostate Specific Antigen (PSA) Response to Bipolar Androgen Therapy + Nivolumab","timeFrame":"2 years"}],"references":[{"citation":"Markowski MC, Taplin ME, Aggarwal R, Sena LA, Wang H, Qi H, Lalji A, Sinibaldi V, Carducci MA, Paller CJ, Marshall CH, Eisenberger MA, Sanin DE, Yegnasubramanian S, Gomes-Alexandre C, Ozbek B, Jones T, De Marzo AM, Denmeade SR, Antonarakis ES. Bipolar androgen therapy plus nivolumab for patients with metastatic castration-resistant prostate cancer: the COMBAT phase II trial. Nat Commun. 2024 Jan 2;15(1):14. doi: 10.1038/s41467-023-44514-2.","pmid":"38167882","type":"DERIVED"}],"start_date":{"date":"2018-09-05","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"COMbination of Bipolar Androgen Therapy and Nivolumab","url":"https://clinicaltrials.gov/study/NCT03554317"},"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/combat-crpc-nct03554317"}