{"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":[["177Lu-PSMA-617","pembrolizumab"]],"indication":"metastatic castration-resistant prostate cancer","name":"NCT03805594","nct_id":"NCT03805594","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03805594. 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":"Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Beginning in cycle 2, participants receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve stable disease (SD) or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.","label":"Part A: Dosing Schedule 1 (lutetium Lu 177-PSMA-617, pembrolizumab)","type":"EXPERIMENTAL"},{"description":"Participants receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.","label":"Part A: Dosing Schedule 2 (lutetium Lu 177-PSMA-617, pembrolizumab)","type":"EXPERIMENTAL"},{"description":"Starting day -21, participants receive pembrolizumab IV over 30 minutes. Participants also receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.","label":"Part A: Dosing Schedule 3 (lutetium Lu 177-PSMA-617, pembrolizumab)","type":"EXPERIMENTAL"},{"description":"Participants will receive the RP2DS determined in Part A. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Participants who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.","label":"Part B: Recommended Phase 2 Dosing Schedule (RP2DS) (lutetium Lu 177-PSMA-617, pembrolizumab)","type":"EXPERIMENTAL"}],"collaborators":["Prostate Cancer Foundation","National Cancer Institute (NCI)"],"completion_date":{"date":"2024-01-10","type":"ACTUAL"},"conditions":["Castration Levels of Testosterone","Castration-Resistant Prostate Carcinoma","Metastatic Prostate Carcinoma","Prostate Adenocarcinoma","Stage IV Prostate Cancer","Stage IVA Prostate Cancer","Stage IVB Prostate Cancer"],"enrollment":{"count":43,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Lutetium Lu 177-PSMA-617","otherNames":["177Lu-PSMA-617","Lu177-PSMA-617"],"type":"DRUG"},{"name":"Pembrolizumab","otherNames":["Keytruda","Lambrolizumab","MK-3475","SCH 900475"],"type":"BIOLOGICAL"}],"last_update":"2025-02-25","lead_sponsor":"University of California, San Francisco","official_title":"Immunogenic Priming With PSMA-Targeted Radioligand Therapy in Advanced Prostate Cancer: A Phase 1b Study of 177Lu-PSMA-617 in Combination With Pembrolizumab","overall_status":"COMPLETED","phases":["PHASE1"],"primary_completion_date":{"date":"2024-01-10","type":"ACTUAL"},"primary_outcomes":[{"measure":"Number of Reported Dose Limiting Toxicities (DLT) (Part A Only)","timeFrame":"Up to 1 year"},{"measure":"Objective Response Rate (ORR) (Part B Only)","timeFrame":"Up to 2 years"}],"references":[{"citation":"Aggarwal R, Starzinski S, de Kouchkovsky I, Koshkin V, Bose R, Chou J, Desai A, Kwon D, Kaushal S, Trihy L, Rastogi M, Ippisch R, Aslam M, Friedlander T, Feng F, Oh D, Cheung A, Small E, Evans M, Fong L, Hope TA. Single-dose 177Lu-PSMA-617 followed by maintenance pembrolizumab in patients with metastatic castration-resistant prostate cancer: an open-label, dose-expansion, phase 1 trial. Lancet Oncol. 2023 Nov;24(11):1266-1276. doi: 10.1016/S1470-2045(23)00451-5.","pmid":"37922930","type":"RESULT"}],"start_date":{"date":"2019-05-10","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"177Lu-PSMA-617 and Pembrolizumab in Treating Patients With Metastatic Castration-Resistant Prostate Cancer","url":"https://clinicaltrials.gov/study/NCT03805594"},"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/nct03805594"}