[{"id":"20c58de1-7df6-4223-a65a-4d8d9fe2e9ac","acronym":"FLAT","url":"https://clinicaltrials.gov/study/NCT05783882","created_at":"2023-03-24T16:04:21.372Z","updated_at":"2024-07-02T16:35:52.322Z","phase":"Phase 3","brief_title":"Prolgolimab 250 mg Q3W in Patients With Unresectable or Metastatic Melanoma","source_id_and_acronym":"NCT05783882 - FLAT","lead_sponsor":"Biocad","biomarkers":" PD-L1","pipe":"","alterations":" ","tags":["PD-L1"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Forteca (prolgolimab)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 114","initiation":"Initiation: 02/01/2022","start_date":" 02/01/2022","primary_txt":" Primary completion: 06/01/2023","primary_completion_date":" 06/01/2023","study_txt":" Completion: 06/01/2023","study_completion_date":" 06/01/2023","last_update_posted":"2023-03-24"},{"id":"b1ccf5af-a065-4ba7-b050-7e670664060b","acronym":"NEO-MIMAJOR","url":"https://clinicaltrials.gov/study/NCT05751928","created_at":"2023-03-02T15:01:35.752Z","updated_at":"2024-07-02T16:35:53.230Z","phase":"Phase 3","brief_title":"A Study of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) in Patients With Resectable Stage III Skin Melanoma","source_id_and_acronym":"NCT05751928 - NEO-MIMAJOR","lead_sponsor":"Biocad","biomarkers":" PD-L1 • BRAF","pipe":" | ","alterations":" BRAF mutation • BRAF V600","tags":["PD-L1 • BRAF"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e BRAF mutation • BRAF V600"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Keytruda (pembrolizumab) • Forteca (prolgolimab) • Nurdati (prolgolimab/nurulimab)"],"overall_status":"Recruiting","enrollment":" Enrollment 410","initiation":"Initiation: 03/01/2023","start_date":" 03/01/2023","primary_txt":" Primary completion: 01/01/2027","primary_completion_date":" 01/01/2027","study_txt":" Completion: 06/01/2027","study_completion_date":" 06/01/2027","last_update_posted":"2023-03-15"},{"id":"d48f7f6b-ee80-4a4b-bab1-707494af07db","acronym":"OCTAVA","url":"https://clinicaltrials.gov/study/NCT05732805","created_at":"2023-02-17T15:00:50.537Z","updated_at":"2024-07-02T16:35:55.249Z","phase":"Phase 3","brief_title":"A Clinical Study of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma","source_id_and_acronym":"NCT05732805 - OCTAVA","lead_sponsor":"Biocad","biomarkers":" PD-L1 • BRAF","pipe":" | ","alterations":" BRAF mutation • BRAF V600","tags":["PD-L1 • BRAF"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e BRAF mutation • BRAF V600"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Forteca (prolgolimab) • Nurdati (prolgolimab/nurulimab)"],"overall_status":"Recruiting","enrollment":" Enrollment 270","initiation":"Initiation: 08/02/2022","start_date":" 08/02/2022","primary_txt":" Primary completion: 04/01/2024","primary_completion_date":" 04/01/2024","study_txt":" Completion: 04/01/2025","study_completion_date":" 04/01/2025","last_update_posted":"2023-02-17"},{"id":"be589c90-92e3-4a29-b9c9-dfc3c78e4b13","acronym":"OBERTON","url":"https://clinicaltrials.gov/study/NCT03913923","created_at":"2021-01-18T19:15:39.098Z","updated_at":"2024-07-02T16:35:55.831Z","phase":"Phase 2","brief_title":"Study of Efficacy and Safety of BCD-217 (Anti-CTLA-4 and Anti-PD-1) Followed By BCD-100 (Anti-PD-1) Versus BCD-100 Monotherapy as First-Line Treatment in Patients With Unresectable or Metastatic Melanoma","source_id_and_acronym":"NCT03913923 - OBERTON","lead_sponsor":"Biocad","biomarkers":" PD-L1 • BRAF","pipe":" | ","alterations":" PD-L1 expression • BRAF V600","tags":["PD-L1 • BRAF"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e PD-L1 expression • BRAF V600"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Forteca (prolgolimab) • Nurdati (prolgolimab/nurulimab)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 117","initiation":"Initiation: 07/01/2019","start_date":" 07/01/2019","primary_txt":" Primary completion: 07/01/2023","primary_completion_date":" 07/01/2023","study_txt":" Completion: 12/01/2023","study_completion_date":" 12/01/2023","last_update_posted":"2023-02-10"},{"id":"f751447d-3279-4b1e-bbcf-d01c341577db","acronym":"DOMINUS","url":"https://clinicaltrials.gov/study/NCT03288870","created_at":"2021-01-18T16:14:51.339Z","updated_at":"2024-07-02T16:36:39.459Z","phase":"Phase 2/3","brief_title":"Efficacy, Safety and Pharmacokinetics of BCD-100 (Anti-PD-1) Monotherapy as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (DOMINUS)","source_id_and_acronym":"NCT03288870 - DOMINUS","lead_sponsor":"Biocad","biomarkers":" EGFR • ALK","pipe":"","alterations":" ","tags":["EGFR • ALK"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e docetaxel • Forteca (prolgolimab)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 218","initiation":"Initiation: 09/19/2017","start_date":" 09/19/2017","primary_txt":" Primary completion: 08/10/2020","primary_completion_date":" 08/10/2020","study_txt":" Completion: 08/10/2021","study_completion_date":" 08/10/2021","last_update_posted":"2020-10-29"},{"id":"7a3c820b-379e-4292-800c-911417d74361","acronym":"MIRACULUM","url":"https://clinicaltrials.gov/study/NCT03269565","created_at":"2021-01-18T16:09:26.033Z","updated_at":"2024-07-02T16:36:40.898Z","phase":"Phase 2","brief_title":"International Trial of the Efficacy and Safety of BCD-100 in Patients With Melanoma","source_id_and_acronym":"NCT03269565 - MIRACULUM","lead_sponsor":"Biocad","biomarkers":" PD-L1","pipe":" | ","alterations":" PD-L1 expression","tags":["PD-L1"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e PD-L1 expression"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Forteca (prolgolimab)"],"overall_status":"Unknown status","enrollment":" Enrollment 126","initiation":"Initiation: 08/31/2017","start_date":" 08/31/2017","primary_txt":" Primary completion: 08/29/2018","primary_completion_date":" 08/29/2018","study_txt":" Completion: 01/01/2021","study_completion_date":" 01/01/2021","last_update_posted":"2020-09-18"},{"id":"b2afc710-ded4-47fa-aae9-eca1b22e426b","acronym":"","url":"https://clinicaltrials.gov/study/NCT03050047","created_at":"2021-01-18T15:01:11.381Z","updated_at":"2024-07-02T16:37:07.289Z","phase":"Phase 1","brief_title":"A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of BCD-100 in Patients With Advanced Solid Tumors","source_id_and_acronym":"NCT03050047","lead_sponsor":"Biocad","biomarkers":" HER-2 • PGR","pipe":"","alterations":" ","tags":["HER-2 • PGR"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Forteca (prolgolimab)"],"overall_status":"Unknown status","enrollment":" Enrollment 15","initiation":"Initiation: 08/30/2016","start_date":" 08/30/2016","primary_txt":" Primary completion: 07/01/2017","primary_completion_date":" 07/01/2017","study_txt":" Completion: 11/01/2018","study_completion_date":" 11/01/2018","last_update_posted":"2018-08-31"}]