{"preliminary_commentary":{"by_channel":{"youtube":6,"podcast":6,"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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT01968109\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"drugs_tested":[["relatlimab","nivolumab"],["relatlimab"],["BMS-986213"]],"indication":"advanced solid tumors","name":"RELATIVITY-020","nct_id":"NCT01968109","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=relativity-020-nct01968109. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. 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_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":1250,"size":"standard","size_rule":"Standard: 151–300 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Relatlimab (BMS-986016) specified dose on specified days","label":"Relatlimab","type":"EXPERIMENTAL"},{"description":"Relatlimab (BMS-986016) + Nivolumab (BMS-936558) specified dose on specified days","label":"Relatlimab + Nivolumab","type":"EXPERIMENTAL"},{"description":"Relatlimab (BMS-986016) + Nivolumab (BMS-936558)","label":"BMS-986213","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2025-02-03","type":"ACTUAL"},"conditions":["Neoplasms by Site"],"enrollment":{"count":1482,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Relatlimab","otherNames":["BMS-986016","Anti-LAG-3 (Anti-Lymphocyte Activation Gene-3)"],"type":"BIOLOGICAL"},{"name":"Nivolumab","otherNames":["Anti-PD-1 (Anti-Programmed-Death-1)","BMS-936558"],"type":"BIOLOGICAL"},{"name":"BMS-986213","otherNames":[],"type":"BIOLOGICAL"}],"last_update":"2026-04-06","lead_sponsor":"Bristol-Myers Squibb","official_title":"A Phase I/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors","overall_status":"COMPLETED","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2024-05-22","type":"ACTUAL"},"primary_outcomes":[{"measure":"Number of Participants With Adverse Events, Deaths and Clinically Relevant Laboratory Abnormalities","timeFrame":"From first dose and within 135 days after last dose of study therapy (Up to approximately 82 months)"},{"measure":"Part C, D1, D2, E - Objective Response Rate Per BICR","timeFrame":"From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 127 months)"},{"measure":"Part C, D1, D2, E - Disease Control Rate (DCR) Per BICR","timeFrame":"From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 127 months)"},{"measure":"Part C, D1, D2, E - Duration of Response (DOR) Per BICR","timeFrame":"From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 127 months)"},{"measure":"Part D1: Number of Participants With Adverse Events in the Broad Scope Standardized MedDRA (SMQ) Anaphylactic Reaction Occurring Within 2 Days of Any Doses of Study Therapy","timeFrame":"From first dose and within 2 days of first dose of study therapy"},{"measure":"Part C, D1, D2, E - Objective Response Rate Per BICR","timeFrame":"From first dose (Day 1) and up to 97 months"}],"references":[{"citation":"Ascierto PA, Tang H, Dolfi S, Nyakas M, Marie Svane I, Munoz-Couselo E, Grob JJ, Gomez-Roca CA, Chiarion-Sileni V, Peltola K, Larkin J, Melero I, Callahan M, Dummer R, Djidel P, Warad D, Reusser-Wolf D, Lipson EJ, Garnett-Benson C. Effect of prior and first-line immunotherapy on baseline immune biomarkers and modulation of the tumor microenvironment in response to nivolumab and relatlimab combination therapy in patients with melanoma from RELATIVITY-020. J Immunother Cancer. 2025 Feb 25;13(2):e009773. doi: 10.1136/jitc-2024-009773.","pmid":"40010775","type":"DERIVED"},{"citation":"Ascierto PA, Lipson EJ, Dummer R, Larkin J, Long GV, Sanborn RE, Chiarion-Sileni V, Dreno B, Dalle S, Schadendorf D, Callahan MK, Nyakas M, Atkinson V, Gomez-Roca CA, Yamazaki N, Tawbi HA, Sarkis N, Warad D, Dolfi S, Mitra P, Suryawanshi S, Grob JJ. Nivolumab and Relatlimab in Patients With Advanced Melanoma That Had Progressed on Anti-Programmed Death-1/Programmed Death Ligand 1 Therapy: Results From the Phase I/IIa RELATIVITY-020 Trial. J Clin Oncol. 2023 May 20;41(15):2724-2735. doi: 10.1200/JCO.22.02072. Epub 2023 Feb 13.","pmid":"36780608","type":"DERIVED"},{"citation":"Huuhtanen J, Kasanen H, Peltola K, Lonnberg T, Glumoff V, Bruck O, Dufva O, Peltonen K, Vikkula J, Jokinen E, Ilander M, Lee MH, Makela S, Nyakas M, Li B, Hernberg M, Bono P, Lahdesmaki H, Kreutzman A, Mustjoki S. Single-cell characterization of anti-LAG-3 and anti-PD-1 combination treatment in patients with melanoma. J Clin Invest. 2023 Mar 15;133(6):e164809. doi: 10.1172/JCI164809.","pmid":"36719749","type":"DERIVED"},{"citation":"Nielsen M, Presti M, Sztupinszki Z, Jensen AWP, Draghi A, Chamberlain CA, Schina A, Yde CW, Wojcik J, Szallasi Z, Crowther MD, Svane IM, Donia M. Coexisting Alterations of MHC Class I Antigen Presentation and IFNgamma Signaling Mediate Acquired Resistance of Melanoma to Post-PD-1 Immunotherapy. Cancer Immunol Res. 2022 Oct 4;10(10):1254-1262. doi: 10.1158/2326-6066.CIR-22-0326.","pmid":"35969233","type":"DERIVED"}],"start_date":{"date":"2013-11-05","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"An Investigational Immuno-therapy Study to Assess the Safety, Tolerability and Effectiveness of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors","url":"https://clinicaltrials.gov/study/NCT01968109"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/relativity-020-nct01968109"}