{"commentary":{"count":191,"free_build_floor":8,"listing_floor":3,"by_channel":{"podcast":66,"x_thread":65,"youtube":60},"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\": \"NCT02563002\", \"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":"NCT02563002","nct_id":"NCT02563002","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct02563002. 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 (Q3W) for up to 35 treatments (approximately 2 years). Participants that have stopped the initial course of pembrolizumab and have stable disease but progress after discontinuation can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 year additional).","label":"Pembrolizumab","type":"EXPERIMENTAL"},{"description":"Participants receive 1 of 6 possible standard chemotherapy regimens: mFOLFOX6, or mFOLFOX6+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or mFOLFOX6+cetuximab 400 mg/m\\^2 IV over 2 hours then 250 mg/m\\^2 over 1 hour weekly in each 2-week cycle, or FOLFIRI, or FOLFIRI+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or FOLFIRI+cetuximab 400 mg/m\\^2 IV over 2 hours then 250 mg/m\\^2 over 1 hour weekly in each 2-week cycle. Participants with documented disease progression following chemotherapy can crossover to receive pembrolizumab for up to 35 cycles (approximately 2 years). Participants that have stopped pembrolizumab and have stable disease but progress after discontinuation can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 year additional).","label":"Standard of Care (SOC)","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2023-07-17","type":"ACTUAL"},"conditions":["Colorectal Carcinoma"],"enrollment":{"count":307,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"mFOLFOX6","type":"DRUG"},{"name":"FOLFIRI","type":"DRUG"},{"name":"Pembrolizumab","type":"BIOLOGICAL"},{"name":"Bevacizumab","type":"BIOLOGICAL"},{"name":"Cetuximab","type":"BIOLOGICAL"}],"last_update":"2024-10-03","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"A Phase III Study of Pembrolizumab (MK-3475) vs. Chemotherapy in Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (KEYNOTE-177)","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2021-02-19","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-Free Survival (PFS) Per RECIST1.1 As Assessed by Central Imaging Vendor","timeFrame":"Up to approximately 59 months"},{"measure":"Overall Survival (OS)","timeFrame":"Up to approximately 59 months"}],"references":[{"citation":"Yoshino T, Andre T, Kim TW, Yong WP, Shiu KK, Jensen BV, Jensen LH, Punt CJA, Smith D, Garcia-Carbonero R, Alcaide-Garcia J, Gibbs P, de la Fouchardiere C, Rivera F, Elez E, Le DT, Adachi N, Fogelman D, Marinello P, Diaz LA Jr. Pembrolizumab in Asian patients with microsatellite-instability-high/mismatch-repair-deficient colorectal cancer. Cancer Sci. 2023 Mar;114(3):1026-1036. doi: 10.1111/cas.15650. Epub 2022 Dec 12.","pmid":"36369901","type":"DERIVED"},{"citation":"Diaz LA Jr, Shiu KK, Kim TW, Jensen BV, Jensen LH, Punt C, Smith D, Garcia-Carbonero R, Benavides M, Gibbs P, de la Fourchardiere C, Rivera F, Elez E, Le DT, Yoshino T, Zhong WY, Fogelman D, Marinello P, Andre T; KEYNOTE-177 Investigators. Pembrolizumab versus chemotherapy for microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer (KEYNOTE-177): final analysis of a randomised, open-label, phase 3 study. Lancet Oncol. 2022 May;23(5):659-670. doi: 10.1016/S1470-2045(22)00197-8. Epub 2022 Apr 12.","pmid":"35427471","type":"DERIVED"},{"citation":"Andre T, Amonkar M, Norquist JM, Shiu KK, Kim TW, Jensen BV, Jensen LH, Punt CJA, Smith D, Garcia-Carbonero R, Sevilla I, De La Fouchardiere C, Rivera F, Elez E, Diaz LA Jr, Yoshino T, Van Cutsem E, Yang P, Farooqui M, Le DT. Health-related quality of life in patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer treated with first-line pembrolizumab versus chemotherapy (KEYNOTE-177): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021 May;22(5):665-677. doi: 10.1016/S1470-2045(21)00064-4. Epub 2021 Apr 1.","pmid":"33812497","type":"DERIVED"},{"citation":"Andre T, Shiu KK, Kim TW, Jensen BV, Jensen LH, Punt C, Smith D, Garcia-Carbonero R, Benavides M, Gibbs P, de la Fouchardiere C, Rivera F, Elez E, Bendell J, Le DT, Yoshino T, Van Cutsem E, Yang P, Farooqui MZH, Marinello P, Diaz LA Jr; KEYNOTE-177 Investigators. Pembrolizumab in Microsatellite-Instability-High Advanced Colorectal Cancer. N Engl J Med. 2020 Dec 3;383(23):2207-2218. doi: 10.1056/NEJMoa2017699.","pmid":"33264544","type":"DERIVED"}],"start_date":{"date":"2015-11-30","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177/KEYNOTE-177)","url":"https://clinicaltrials.gov/study/NCT02563002"},"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/nct02563002"}