{"preliminary_commentary":{"by_channel":{"youtube":1,"podcast":1,"bluesky_thread":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"TOPACIO","nct_id":"NCT02657889","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=topacio-nct02657889. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. 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_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"TOPACIO","arms":[{"description":"Phase 1: Dose-escalation: ascending doses of niraparib up to 300mg/day orally (PO) on Days 1-21 and pembrolizumab 200mg intravenously (IV) on Day 1 of each 21-day cycle\n\nPhase 2: niraparib (recommended Phase 2 dose) in combination with pembrolizumab 200mg IV on Day 1 of each 21-day cycle","label":"niraparib plus pembrolizumab","type":"EXPERIMENTAL"}],"collaborators":["Merck Sharp & Dohme LLC"],"completion_date":{"date":"2021-09-17","type":"ACTUAL"},"conditions":["Neoplasms","Triple Negative Breast Cancer","Ovarian Cancer","Breast Cancer","Metastatic Breast Cancer","Advanced Breast Cancer","Stage IV Breast Cancer","Fallopian Tube Cancer","Peritoneal Cancer"],"enrollment":{"count":122,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"niraparib","otherNames":[],"type":"DRUG"},{"name":"pembrolizumab","otherNames":[],"type":"BIOLOGICAL"}],"last_update":"2022-12-01","lead_sponsor":"Tesaro, Inc.","official_title":"Phase 1/2 Clinical Study of Niraparib in Combination With Pembrolizumab (MK-3475) in Patients With Advanced or Metastatic Triple-Negative Breast Cancer and in Patients With Recurrent Ovarian Cancer","overall_status":"COMPLETED","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2018-05-14","type":"ACTUAL"},"primary_outcomes":[{"measure":"Phase 1: Number of Participants Reporting Dose-Limiting Toxicities (DLTs)","timeFrame":"During Cycle 1, ie, during the first 21 days of treatment"},{"measure":"Phase 2: Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1","timeFrame":"Up to 40 weeks"}],"references":[{"citation":"Farkkila A, Gulhan DC, Casado J, Jacobson CA, Nguyen H, Kochupurakkal B, Maliga Z, Yapp C, Chen YA, Schapiro D, Zhou Y, Graham JR, Dezube BJ, Munster P, Santagata S, Garcia E, Rodig S, Lako A, Chowdhury D, Shapiro GI, Matulonis UA, Park PJ, Hautaniemi S, Sorger PK, Swisher EM, D'Andrea AD, Konstantinopoulos PA. Immunogenomic profiling determines responses to combined PARP and PD-1 inhibition in ovarian cancer. Nat Commun. 2020 Mar 19;11(1):1459. doi: 10.1038/s41467-020-15315-8.","pmid":"32193378","type":"DERIVED"},{"citation":"Konstantinopoulos PA, Waggoner S, Vidal GA, Mita M, Moroney JW, Holloway R, Van Le L, Sachdev JC, Chapman-Davis E, Colon-Otero G, Penson RT, Matulonis UA, Kim YB, Moore KN, Swisher EM, Farkkila A, D'Andrea A, Stringer-Reasor E, Wang J, Buerstatte N, Arora S, Graham JR, Bobilev D, Dezube BJ, Munster P. Single-Arm Phases 1 and 2 Trial of Niraparib in Combination With Pembrolizumab in Patients With Recurrent Platinum-Resistant Ovarian Carcinoma. JAMA Oncol. 2019 Aug 1;5(8):1141-1149. doi: 10.1001/jamaoncol.2019.1048.","pmid":"31194228","type":"DERIVED"},{"citation":"Vinayak S, Tolaney SM, Schwartzberg L, Mita M, McCann G, Tan AR, Wahner-Hendrickson AE, Forero A, Anders C, Wulf GM, Dillon P, Lynce F, Zarwan C, Erban JK, Zhou Y, Buerstatte N, Graham JR, Arora S, Dezube BJ, Telli ML. Open-label Clinical Trial of Niraparib Combined With Pembrolizumab for Treatment of Advanced or Metastatic Triple-Negative Breast Cancer. JAMA Oncol. 2019 Aug 1;5(8):1132-1140. doi: 10.1001/jamaoncol.2019.1029.","pmid":"31194225","type":"DERIVED"}],"start_date":{"date":"2016-04-15","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer","url":"https://clinicaltrials.gov/study/NCT02657889"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/topacio-nct02657889"}