{"commentary":{"count":50,"free_build_floor":8,"listing_floor":3,"by_channel":{"podcast":26,"youtube":17,"x_thread":7},"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\": \"NCT03553836\", \"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":"NCT03553836","nct_id":"NCT03553836","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03553836. 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 200 mg pembrolizumab (2 mg/kg for a maximum of 200 mg in pediatric participants) by intravenous (IV) infusion once every 3 weeks (Q3W; 21-day cycles) for up to 17 cycles (up to \\~1 year) in Part 1. Participants who complete the initial treatment of 17 cycles of pembrolizumab and experience disease recurrence may be eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \\~2 years) in Part 2.","label":"Pembrolizumab","type":"EXPERIMENTAL"},{"description":"Participants receive saline placebo by IV infusion Q3W (21-day cycles) for up to 17 cycles (up to \\~1 year) in Part 1. Participants who complete the initial treatment of 17 cycles of placebo and experience disease recurrence may be eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \\~2 years) in Part 2.","label":"Placebo","type":"PLACEBO_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2033-10-12","type":"ESTIMATED"},"conditions":["Melanoma"],"enrollment":{"count":976,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Pembrolizumab","type":"BIOLOGICAL"},{"name":"Placebo","type":"OTHER"}],"last_update":"2024-11-29","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"Adjuvant Therapy With Pembrolizumab Versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE-716)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2021-06-21","type":"ACTUAL"},"primary_outcomes":[{"measure":"Recurrence-free Survival (RFS)","timeFrame":"Up to ~32.7 months"}],"references":[{"citation":"Luke JJ, Ascierto PA, Khattak MA, de la Cruz Merino L, Del Vecchio M, Rutkowski P, Spagnolo F, Mackiewicz J, Chiarion-Sileni V, Kirkwood JM, Robert C, Grob JJ, de Galitiis F, Schadendorf D, Carlino MS, Wu XL, Fukunaga-Kalabis M, Krepler C, Eggermont AMM, Long GV. Pembrolizumab Versus Placebo as Adjuvant Therapy in Resected Stage IIB or IIC Melanoma: Final Analysis of Distant Metastasis-Free Survival in the Phase III KEYNOTE-716 Study. J Clin Oncol. 2024 May 10;42(14):1619-1624. doi: 10.1200/JCO.23.02355. Epub 2024 Mar 7.","pmid":"38452313","type":"RESULT"},{"citation":"Leachman SA, Luke JJ, Ascierto PA, Long GV, Khattak MA, Rutkowski P, Xu ZJ, Fukunaga-Kalabis M, Krepler C, Eggermont AMM, Schadendorf D. Adjuvant Pembrolizumab for Stage IIB or IIC Melanoma: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2026 Feb 2;9(2):e2559603. doi: 10.1001/jamanetworkopen.2025.59603.","pmid":"41701495","type":"DERIVED"},{"citation":"Luke JJ, Ascierto PA, Khattak MA, Rutkowski P, Del Vecchio M, Spagnolo F, Mackiewicz J, Merino LC, Chiarion-Sileni V, Kirkwood JM, Robert C, Schadendorf D, de Galitiis F, Carlino MS, Dummer R, Mohr P, Odeleye-Ajakaye A, Fukunaga-Kalabis M, Krepler C, Eggermont AMM, Long GV. Pembrolizumab versus placebo as adjuvant therapy in resected stage IIB or IIC melanoma: Long-term follow-up, crossover, and rechallenge with pembrolizumab in the phase III KEYNOTE-716 study. Eur J Cancer. 2025 May 2;220:115381. doi: 10.1016/j.ejca.2025.115381. Epub 2025 Mar 23.","pmid":"40198940","type":"DERIVED"},{"citation":"Wurcel V, Rojas Rojas M, Urrego-Reyes J, Medrano Rivera D, Acevedo R, Jiang R, Jiang S, Zhang S, Caparros A, Krepler C, Fukunaga-Kalabis M, Younan ND, Alexander D, Hughes R, Weston G. Number needed to treat (NNT) with pembrolizumab as an adjuvant therapy in resected patients with high-risk stage II (IIB and IIC) melanoma and its application to cost of preventing an event (COPE) in Mexico. J Med Econ. 2025 Dec;28(1):346-353. doi: 10.1080/13696998.2025.2466365. Epub 2025 Mar 13.","pmid":"40078077","type":"DERIVED"},{"citation":"Schadendorf D, Luke JJ, Ascierto PA, Long GV, Rutkowski P, Khattak A, Del Vecchio M, de la Cruz-Merino L, Mackiewicz J, Sileni VC, Kirkwood JM, Robert C, Grob JJ, Dummer R, Carlino MS, Zhao Y, Kalabis M, Krepler C, Eggermont A, Scolyer RA. Pembrolizumab versus placebo as adjuvant therapy in resected stage IIB or IIC melanoma: Outcomes in histopathologic subgroups from the randomized, double-blind, phase 3 KEYNOTE-716 trial. J Immunother Cancer. 2024 Mar 13;12(3):e007501. doi: 10.1136/jitc-2023-007501.","pmid":"38485189","type":"DERIVED"},{"citation":"Favre-Bulle A, Bencina G, Zhang S, Jiang R, Andritschke D, Bhadhuri A. Cost-effectiveness of pembrolizumab as an adjuvant treatment for patients with resected stage IIB or IIC melanoma in Switzerland. J Med Econ. 2023 Jan-Dec;26(1):283-292. doi: 10.1080/13696998.2023.2174748.","pmid":"36748342","type":"DERIVED"},{"citation":"Long GV, Luke JJ, Khattak MA, de la Cruz Merino L, Del Vecchio M, Rutkowski P, Spagnolo F, Mackiewicz J, Chiarion-Sileni V, Kirkwood JM, Robert C, Grob JJ, de Galitiis F, Schadendorf D, Carlino MS, Mohr P, Dummer R, Gershenwald JE, Yoon CH, Wu XL, Fukunaga-Kalabis M, Krepler C, Eggermont AMM, Ascierto PA; KEYNOTE-716 Investigators. Pembrolizumab versus placebo as adjuvant therapy in resected stage IIB or IIC melanoma (KEYNOTE-716): distant metastasis-free survival results of a multicentre, double-blind, randomised, phase 3 trial. Lancet Oncol. 2022 Nov;23(11):1378-1388. doi: 10.1016/S1470-2045(22)00559-9. Epub 2022 Oct 18.","pmid":"36265502","type":"DERIVED"},{"citation":"Luke JJ, Rutkowski P, Queirolo P, Del Vecchio M, Mackiewicz J, Chiarion-Sileni V, de la Cruz Merino L, Khattak MA, Schadendorf D, Long GV, Ascierto PA, Mandala M, De Galitiis F, Haydon A, Dummer R, Grob JJ, Robert C, Carlino MS, Mohr P, Poklepovic A, Sondak VK, Scolyer RA, Kirkwood JM, Chen K, Diede SJ, Ahsan S, Ibrahim N, Eggermont AMM; KEYNOTE-716 Investigators. Pembrolizumab versus placebo as adjuvant therapy in completely resected stage IIB or IIC melanoma (KEYNOTE-716): a randomised, double-blind, phase 3 trial. Lancet. 2022 Apr 30;399(10336):1718-1729. doi: 10.1016/S0140-6736(22)00562-1. Epub 2022 Apr 1.","pmid":"35367007","type":"DERIVED"},{"citation":"Luke JJ, Ascierto PA, Carlino MS, Gershenwald JE, Grob JJ, Hauschild A, Kirkwood JM, Long GV, Mohr P, Robert C, Ross M, Scolyer RA, Yoon CH, Poklepovic A, Rutkowski P, Anderson JR, Ahsan S, Ibrahim N, M Eggermont AM. KEYNOTE-716: Phase III study of adjuvant pembrolizumab versus placebo in resected high-risk stage II melanoma. Future Oncol. 2020 Jan;16(3):4429-4438. doi: 10.2217/fon-2019-0666. Epub 2019 Dec 24.","pmid":"31870188","type":"DERIVED"}],"start_date":{"date":"2018-09-12","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Safety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma (MK-3475-716/KEYNOTE-716)","url":"https://clinicaltrials.gov/study/NCT03553836"},"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/nct03553836"}