{"commentary":{"count":131,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":70,"podcast":55,"x_thread":6},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT02819518\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"NCT02819518","nct_id":"NCT02819518","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct02819518. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1950,"size":"deep","size_rule":"Deep: 41+ commentary sources"},"registry":{"acronym":null,"arms":[{"description":"Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel 100 mg/m\\^2 IV on Days 1, 8 and 15 of each 28-day cycle.","label":"Part 1: Pembrolizumab + Nab-paclitaxel","type":"EXPERIMENTAL"},{"description":"Participants receive pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel 90 mg/m\\^2 IV on Days 1, 8 and 15 of each 28-day cycle.","label":"Part 1: Pembrolizumab + Paclitaxel","type":"EXPERIMENTAL"},{"description":"Participants receive pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin 1000 mg/m\\^2 (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.","label":"Part 1: Pembrolizumab + Gemcitabine/Carboplatin","type":"EXPERIMENTAL"},{"description":"Participants receive pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m\\^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m\\^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m\\^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.","label":"Part 2: Pembrolizumab + Chemotherapy","type":"EXPERIMENTAL"},{"description":"Participants receive placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m\\^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m\\^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m\\^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.","label":"Part 2: Placebo + Chemotherapy","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2023-10-30","type":"ACTUAL"},"conditions":["Triple Negative Breast Cancer (TNBC)"],"enrollment":{"count":882,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Pembrolizumab","type":"BIOLOGICAL"},{"name":"Nab-paclitaxel","type":"DRUG"},{"name":"Paclitaxel","type":"DRUG"},{"name":"Gemcitabine","type":"DRUG"},{"name":"Carboplatin","type":"DRUG"},{"name":"Normale Saline Solution","type":"DRUG"}],"last_update":"2024-11-27","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"A Randomized, Double-Blind, Phase III Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer - (KEYNOTE-355)","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2021-06-15","type":"ACTUAL"},"primary_outcomes":[{"measure":"Part 1: Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants","timeFrame":"Up to approximately 39 months"},{"measure":"Part 1: Percentage of Participants Who Discontinued Study Drug Due to an AE - All Participants","timeFrame":"Up to approximately 39 months"},{"measure":"Part 2: Progression-Free Survival (PFS) - All Participants","timeFrame":"Up to approximately 53 months"},{"measure":"Part 2: PFS - Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 Tumors","timeFrame":"Up to approximately 53 months"},{"measure":"Part 2: PFS - Participants With PD-L1 CPS ≥10 Tumors","timeFrame":"Up to approximately 53 months"},{"measure":"Part 2: Overall Survival (OS) - All Participants","timeFrame":"Up to approximately 53 months"},{"measure":"Part 2: OS - Participants With PD-L1 CPS ≥1 Tumors","timeFrame":"Up to approximately 53 months"},{"measure":"Part 2: OS - Participants With PD-L1 CPS ≥10 Tumors","timeFrame":"Up to approximately 53 months"}],"references":[{"citation":"Rugo HS, Cescon DW, Schmid P, Nowecki Z, Im SA, Md Yusof M, Gallardo C, Iwata H, Lipatov O, Cruz F, Barrios CH, Hegg R, Loi S, Gion M, Otero MT, Arkosy P, Tarnawski R, Yao L, Mejia J, Pan W, Cortes J. Outcomes in KEYNOTE-355 after chemotherapy discontinuation before pembrolizumab discontinuation and with immune-mediated adverse events. NPJ Breast Cancer. 2026 Jun 26. doi: 10.1038/s41523-026-00971-8. Online ahead of print.","pmid":"42362563","type":"DERIVED"},{"citation":"Im SA, Cortes J, Cescon DW, Yusof MM, Iwata H, Masuda N, Takano T, Huang CS, Chung CF, Tsugawa K, Park YH, Matsumoto K, Inoue K, Kwong A, Loi S, Fu W, Pan W, Karantza V, Rugo HS, Schmid P. Results from the randomized KEYNOTE-355 study of pembrolizumab plus chemotherapy for Asian patients with advanced TNBC. NPJ Breast Cancer. 2024 Sep 12;10(1):79. doi: 10.1038/s41523-024-00679-7.","pmid":"39266535","type":"DERIVED"},{"citation":"Cortes J, Rugo HS, Cescon DW, Im SA, Yusof MM, Gallardo C, Lipatov O, Barrios CH, Perez-Garcia J, Iwata H, Masuda N, Torregroza Otero M, Gokmen E, Loi S, Guo Z, Zhou X, Karantza V, Pan W, Schmid P; KEYNOTE-355 Investigators. Pembrolizumab plus Chemotherapy in Advanced Triple-Negative Breast Cancer. N Engl J Med. 2022 Jul 21;387(3):217-226. doi: 10.1056/NEJMoa2202809.","pmid":"35857659","type":"DERIVED"},{"citation":"Cortes J, Cescon DW, Rugo HS, Nowecki Z, Im SA, Yusof MM, Gallardo C, Lipatov O, Barrios CH, Holgado E, Iwata H, Masuda N, Otero MT, Gokmen E, Loi S, Guo Z, Zhao J, Aktan G, Karantza V, Schmid P; KEYNOTE-355 Investigators. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (KEYNOTE-355): a randomised, placebo-controlled, double-blind, phase 3 clinical trial. Lancet. 2020 Dec 5;396(10265):1817-1828. doi: 10.1016/S0140-6736(20)32531-9.","pmid":"33278935","type":"DERIVED"}],"start_date":{"date":"2016-07-27","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs. Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (MK-3475-355/KEYNOTE-355)","url":"https://clinicaltrials.gov/study/NCT02819518"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct02819518"}