{"commentary":{"count":6,"free_build_floor":8,"listing_floor":3,"by_channel":{"podcast":3,"youtube":2,"x_thread":1},"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":false},"name":"FORWARD I","nct_id":"NCT02631876","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=forward-i-nct02631876. 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":750,"size":"focused","size_rule":"Focused: 1–12 commentary sources"},"registry":{"acronym":"FORWARD I","arms":[{"description":"Participants will receive mirvetuximab soravtansine at 6 milligrams/kilogram (mg/kg) adjusted ideal body weight (AIBW) administered intravenously (IV) on Day 1 of a 3 week cycle. Participants will continue to receive study drug until they experience progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (as assessed by the blinded independent review committee \\[BIRC\\]), experience unacceptable toxicity, or withdraw consent, whichever comes first, or until the sponsor terminate the study. (Maximum exposure: 86.9 weeks)","label":"Mirvetuximab Soravtansine","type":"EXPERIMENTAL"},{"description":"Participants will receive a dose of IC chemotherapeutic agent calculated using body surface area (BSA). Paclitaxel will be administered at 80 milligrams/square meter (mg/m\\^2) as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan will be administered at 4 mg/m\\^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could be administered at 1.25 mg/m\\^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin will be administered at 40 mg/m\\^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could be administered as a 1-hour infusion. Participants will continue to receive study drug until they experience PD per RECIST version 1.1 (as assessed by BIRC), experience unacceptable toxicity, or withdraw consent, whichever comes first, or until the sponsor terminate the study. (Maximum exposure: 62.9 weeks)","label":"Investigator's Choice (IC) Chemotherapy","type":"EXPERIMENTAL"}],"collaborators":["Gynecologic Oncology Group"],"completion_date":{"date":"2020-01","type":"ACTUAL"},"conditions":["Epithelial Ovarian Cancer","Primary Peritoneal Carcinoma","Fallopian Tube Cancer","Ovarian Cancer"],"enrollment":{"count":366,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Mirvetuximab soravtansine","type":"DRUG"},{"name":"Paclitaxel","type":"DRUG"},{"name":"Pegylated liposomal doxorubicin","type":"DRUG"},{"name":"Topotecan","type":"DRUG"}],"last_update":"2020-10-14","lead_sponsor":"ImmunoGen, Inc.","official_title":"FORWARD I: A Randomized, Open Label Phase 3 Study to Evaluate the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) Versus Investigator's Choice of Chemotherapy in Women With Folate Receptor Alpha Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2019-01","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-Free Survival (PFS), as Assessed by BIRC Per RECIST Version 1.1 in All Participants Randomized to the Study","timeFrame":"From the date of randomization until the time of death or PD (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)"},{"measure":"PFS, as Assessed by BIRC Per RECIST Version 1.1 in Participants With High Folate Receptor Alpha Level (≥ 75% of Tumor Staining)","timeFrame":"From the date of randomization until the time of death or PD (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)"}],"references":[{"citation":"Moore KN, Oza AM, Colombo N, Oaknin A, Scambia G, Lorusso D, Konecny GE, Banerjee S, Murphy CG, Tanyi JL, Hirte H, Konner JA, Lim PC, Prasad-Hayes M, Monk BJ, Pautier P, Wang J, Berkenblit A, Vergote I, Birrer MJ. Phase III, randomized trial of mirvetuximab soravtansine versus chemotherapy in patients with platinum-resistant ovarian cancer: primary analysis of FORWARD I. Ann Oncol. 2021 Jun;32(6):757-765. doi: 10.1016/j.annonc.2021.02.017. Epub 2021 Mar 2.","pmid":"33667670","type":"DERIVED"}],"start_date":{"date":"2016-03-02","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Women With Folate Receptor (FR) Alpha Positive Advanced Epithelial Ovarian Cancer (EOC), Primary Peritoneal or Fallopian Tube Cancer","url":"https://clinicaltrials.gov/study/NCT02631876"},"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/forward-i-nct02631876"}