{"commentary":{"count":18,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":10,"youtube":6,"podcast":2},"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\": \"NCT03767348\", \"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":"IGNYTE","nct_id":"NCT03767348","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=ignyte-nct03767348. 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":1250,"size":"standard","size_rule":"Standard: 13–40 commentary sources"},"registry":{"acronym":"IGNYTE","arms":[{"description":"anti-PD-1 monoclonal antibody","label":"Dose escalation of RP1 by intratumoral (IT) injection in superficial tumors","type":"EXPERIMENTAL"},{"description":"Dose escalation of RP1 alone in 3 cohorts with IT injections in superficial tumors","label":"Dose escalation of RP1 by intratumoral (IT) injection in deep/visceral tumors","type":"EXPERIMENTAL"},{"description":"Dose escalation of RP1 alone in 3 cohorts with IT injections in superficial tumors","label":"Dose expansion of RP1 and nivolumab (IV) in superficial tumors","type":"EXPERIMENTAL"},{"description":"Doses of RP1 (IT) in deep/visceral tumors with nivolumab (IV)","label":"Dose expansion of RP1 and nivolumab (IV) in deep/visceral tumors","type":"EXPERIMENTAL"},{"description":"Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with melanoma","label":"RP1 (IT) and nivolumab (IV) in melanoma","type":"EXPERIMENTAL"},{"description":"Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with MSI-H or dMMR solid tumors","label":"RP1 (IT) and nivolumab (IV) in MSI-H/dMMR solid tumors","type":"EXPERIMENTAL"},{"description":"Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with non-melanoma skin cancer","label":"RP1 (IT) and nivolumab (IV) in NMSC","type":"EXPERIMENTAL"},{"description":"Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with cutaneous melanoma who have been previously treated with anti-PD1 therapy","label":"RP1(IT) and nivolumab (IV) in anti-PD1 Failed Cutaneous Melanoma","type":"EXPERIMENTAL"},{"description":"Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with non-melanoma skin cancer who have been previously treated with anti-PD1/PD-L1 therapy","label":"RP1(IT) and nivolumab (IV) in anti-PD1/PD-L1 Failed NMSC","type":"EXPERIMENTAL"},{"description":"Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with non small cell lung cancer who have been previously treated with anti-PD1/PD-L1 therapy","label":"RP1(IT) and nivolumab (IV) in anti-PD1/PD-L1 Failed NSCLC","type":"EXPERIMENTAL"}],"collaborators":["Bristol-Myers Squibb"],"completion_date":{"date":"2028-12","type":"ESTIMATED"},"conditions":["Non-Small Cell Lung Cancer (NSCLC)","Microsatellite Instability-High (MSI-H)","Non-melanoma Skin Cancer (NMSC)","Cutaneous Melanoma"],"enrollment":{"count":340,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"RP1","type":"BIOLOGICAL"},{"name":"nivolumab","type":"BIOLOGICAL"}],"last_update":"2026-02-13","lead_sponsor":"Replimune, Inc.","official_title":"An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination With PD1 Blockade in Patients With Solid Tumors [IGNYTE]","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2028-06","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Percentage of adverse events (AEs)","timeFrame":"26 months"},{"measure":"Percentage of serious adverse events (SAEs)","timeFrame":"26 months"},{"measure":"Percentage of dose limiting toxicities (DLTs)","timeFrame":"26 months"},{"measure":"Percentage of overall response rate (ORR)","timeFrame":"26 months"},{"measure":"Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RP1","timeFrame":"20 weeks"}],"references":[{"citation":"Wong MK, Milhem MM, Sacco JJ, Michels J, In GK, Munoz Couselo E, Schadendorf D, Beasley GM, Niu J, Chmielowski B, Wise-Draper TM, Bowles TL, Tsai KK, Lebbe C, Gaudy-Marqueste C, Middleton MR, Skolariki A, Samson A, Chesney JA, VanderWalde AM, Zakharia Y, Harrington KJ, Appleton E, Bommareddy PK, Zhu J, Viana M, Hou JW, Coffin RS, Robert C. RP1 Combined With Nivolumab in Advanced Anti-PD-1-Failed Melanoma (IGNYTE). J Clin Oncol. 2025 Nov 20;43(33):3589-3599. doi: 10.1200/JCO-25-01346. Epub 2025 Jul 8.","pmid":"40627813","type":"DERIVED"},{"citation":"Thomas S, Kuncheria L, Roulstone V, Kyula JN, Mansfield D, Bommareddy PK, Smith H, Kaufman HL, Harrington KJ, Coffin RS. Development of a new fusion-enhanced oncolytic immunotherapy platform based on herpes simplex virus type 1. J Immunother Cancer. 2019 Aug 10;7(1):214. doi: 10.1186/s40425-019-0682-1.","pmid":"31399043","type":"DERIVED"}],"start_date":{"date":"2017-09-20","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE)","url":"https://clinicaltrials.gov/study/NCT03767348"},"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/ignyte-nct03767348"}