{"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":[["pembrolizumab"]],"indication":"advanced or metastatic urothelial carcinoma","name":"KEYNOTE-361","nct_id":"NCT02853305","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=keynote-361-nct02853305. 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":null,"arms":[{"description":"Participants receive pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m\\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle + gemcitabine IV infusion 1,000 mg/m\\^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle + gemcitabine 1,000 mg/m\\^2 IV on Day 1 and Day 8 of each 3-week cycle. Eligible participants who stop pembrolizumab with Stable Disease (SD) or better but progress after discontinuation may be able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.","label":"Pembrolizumab + ST Chemotherapy (Pembro Combo)","type":"EXPERIMENTAL"},{"description":"Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses. Eligible participants who stop pembrolizumab with SD or better but progress after discontinuation may be able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.","label":"Pembrolizumab (Pembro)","type":"EXPERIMENTAL"},{"description":"Participants receive ST chemotherapy with EITHER cisplatin 70 mg/m\\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle + gemcitabine IV infusion 1,000 mg/m\\^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle + gemcitabine 1,000 mg/m\\^2 IV on Day 1 and Day 8 of each 3-week cycle.","label":"ST Chemotherapy (Chemo)","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2022-09-15","type":"ACTUAL"},"conditions":["Urothelial Carcinoma Associated 1 RNA, Human"],"enrollment":{"count":1010,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Pembrolizumab","otherNames":["MK-3475","KEYTRUDA®"],"type":"BIOLOGICAL"},{"name":"Cisplatin","otherNames":[],"type":"DRUG"},{"name":"Carboplatin","otherNames":[],"type":"DRUG"},{"name":"Gemcitabine","otherNames":[],"type":"DRUG"}],"last_update":"2023-09-08","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"A Phase III Randomized, Controlled Clinical Trial of Pembrolizumab With or Without Platinum-Based Combination Chemotherapy Versus Chemotherapy in Subjects With Advanced or Metastatic Urothelial Carcinoma","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2020-04-29","type":"ACTUAL"},"primary_outcomes":[{"measure":"Pembro Combo vs Chemo: Progression-free Survival (PFS) Using Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)","timeFrame":"Up to approximately 42 months"},{"measure":"Pembro Combo vs Chemo: Overall Survival (OS)","timeFrame":"Up to approximately 42 months"},{"measure":"Pembro vs Chemo: OS in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10%","timeFrame":"Up to approximately 42 months"},{"measure":"Pembro vs Chemo: OS","timeFrame":"Up to approximately 42 months"}],"references":[{"citation":"Giannatempo P, Machiels JP, Sassa N, Arranz JA, Fujii Y, Su WP, Keam B, Culine S, Shen YC, Langa JM, Sarid D, Aarts M, Calabro F, Rosenbaum E, Moreno BH, Bavle A, Xu JZ, Rha SY. Impact of Histology on Clinical Outcomes of Pembrolizumab Monotherapy in Patients With Advanced or Metastatic Urothelial Carcinoma in the Phase 3 KEYNOTE-045 and KEYNOTE-361 Trials. Clin Genitourin Cancer. 2025 Apr;23(2):102273. doi: 10.1016/j.clgc.2024.102273. Epub 2024 Nov 15.","pmid":"40037029","type":"DERIVED"},{"citation":"Flechon A, Morales-Barrera R, Powles T, Alva A, Ozguroglu M, Csoszi T, Loriot Y, Rodriguez-Vida A, Geczi L, Cheng SY, Fradet Y, Oudard S, Vulsteke C, Gunduz S, Mamtani R, Yu EY, Montesa Pino A, Anido U, Sendur MAN, Gravis G, Revesz J, Kostorov V, Huillard O, Ma J, Rajasagi M, Vajdi A, Lunceford J, Cristescu R, Imai K, Homet Moreno B, Matsubara N. Association of Tumor Mutational Burden and PD-L1 with the Efficacy of Pembrolizumab with or without Chemotherapy versus Chemotherapy in Advanced Urothelial Carcinoma. Clin Cancer Res. 2024 Dec 2;30(23):5353-5364. doi: 10.1158/1078-0432.CCR-23-3518.","pmid":"39475359","type":"DERIVED"},{"citation":"Powles T, Chang YH, Yamamoto Y, Munoz J, Reyes-Cosmelli F, Peer A, Cohen G, Yu EY, Lorch A, Bavle A, Homet Moreno B, Markensohn J, Edmondson M, Chen C, Cristescu R, Pena C, Lunceford J, Gunduz S. Pembrolizumab for advanced urothelial carcinoma: exploratory ctDNA biomarker analyses of the KEYNOTE-361 phase 3 trial. Nat Med. 2024 Sep;30(9):2508-2516. doi: 10.1038/s41591-024-03091-7. Epub 2024 Jun 1.","pmid":"38823511","type":"DERIVED"},{"citation":"Topp BG, Channavazzala M, Mayawala K, De Alwis DP, Rubin E, Snyder A, Wolchok JD, Ribas A. Tumor dynamics in patients with solid tumors treated with pembrolizumab beyond disease progression. Cancer Cell. 2023 Sep 11;41(9):1680-1688.e2. doi: 10.1016/j.ccell.2023.08.004.","pmid":"37699333","type":"DERIVED"},{"citation":"Powles T, Csoszi T, Ozguroglu M, Matsubara N, Geczi L, Cheng SY, Fradet Y, Oudard S, Vulsteke C, Morales Barrera R, Flechon A, Gunduz S, Loriot Y, Rodriguez-Vida A, Mamtani R, Yu EY, Nam K, Imai K, Homet Moreno B, Alva A; KEYNOTE-361 Investigators. Pembrolizumab alone or combined with chemotherapy versus chemotherapy as first-line therapy for advanced urothelial carcinoma (KEYNOTE-361): a randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Jul;22(7):931-945. doi: 10.1016/S1470-2045(21)00152-2. Epub 2021 May 26.","pmid":"34051178","type":"DERIVED"}],"start_date":{"date":"2016-09-15","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Pembrolizumab With or Without Platinum-based Combination Chemotherapy Versus Chemotherapy Alone in Urothelial Carcinoma (MK-3475-361/KEYNOTE-361)","url":"https://clinicaltrials.gov/study/NCT02853305"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/keynote-361-nct02853305"}