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12/01/2026","last_update_posted":"2025-02-24"},{"id":"4cfc5715-dc42-47d6-8b29-f4162141b070","acronym":"20-C-0012","url":"https://clinicaltrials.gov/study/NCT04235777","created_at":"2021-01-29T07:20:15.829Z","updated_at":"2025-02-25T13:40:02.108Z","phase":"Phase 1","brief_title":"Bintrafusp Alfa (M7824) and PDS01ADC Alone and in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Metastatic Non-Prostate Genitourinary Malignancies","source_id_and_acronym":"NCT04235777 - 20-C-0012","lead_sponsor":"National Cancer Institute (NCI)","biomarkers":" CD4","pipe":" | ","alterations":" PD-L1 expression","tags":["CD4"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e PD-L1 expression"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e bintrafusp alfa (M7824) • PDS01ADC"],"overall_status":"Recruiting","enrollment":" Enrollment 100","initiation":"Initiation: 07/13/2020","start_date":" 07/13/2020","primary_txt":" Primary completion: 12/01/2027","primary_completion_date":" 12/01/2027","study_txt":" Completion: 12/01/2027","study_completion_date":" 12/01/2027","last_update_posted":"2025-02-21"},{"id":"1bb11f50-7b59-4eb4-901f-d7b6ac9b157d","acronym":"","url":"https://clinicaltrials.gov/study/NCT04287868","created_at":"2021-01-18T20:48:45.296Z","updated_at":"2025-02-25T14:07:41.725Z","phase":"Phase 1/2","brief_title":"Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies","source_id_and_acronym":"NCT04287868","lead_sponsor":"National Cancer Institute (NCI)","biomarkers":" PD-L1 • CDKN2A • CD4","pipe":" | ","alterations":" PD-L1 negative","tags":["PD-L1 • CDKN2A • CD4"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e PD-L1 negative"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e bintrafusp alfa (M7824) • Versamune HPV • PDS01ADC"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 51","initiation":"Initiation: 06/09/2020","start_date":" 06/09/2020","primary_txt":" Primary completion: 07/26/2022","primary_completion_date":" 07/26/2022","study_txt":" Completion: 07/01/2026","study_completion_date":" 07/01/2026","last_update_posted":"2025-02-19"},{"id":"ba15135a-7176-4f0e-a8cc-e6c040cf6509","acronym":"","url":"https://clinicaltrials.gov/study/NCT04574583","created_at":"2021-01-18T21:50:28.241Z","updated_at":"2025-02-25T17:00:40.932Z","phase":"Phase 1/2","brief_title":"Phase I/II Trial Investigating the Safety, Tolerability, Pharmacokinetics, Immune and Clinical Activity of SX-682 in Combination With BinTrafusp Alfa (M7824 or TGF-beta \"Trap\"/PD-L1) With CV301 TRICOM in Advanced Solid Tumors (STAT)","source_id_and_acronym":"NCT04574583","lead_sponsor":"National Cancer Institute (NCI)","biomarkers":" HER-2 • PD-L1 • ER • PGR • CD4","pipe":" | ","alterations":" HER-2 amplification • HER-2 negative","tags":["HER-2 • PD-L1 • ER • PGR • CD4"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 amplification • HER-2 negative"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e 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class=\"violet\"\u003e|\u003c/b\u003e Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • paclitaxel • docetaxel • 5-fluorouracil • pemetrexed • Jemperli (dostarlimab-gxly) • bintrafusp alfa (M7824) • cobolimab (TSR-022) • feladilimab (GSK3359609) • GSK3174998"],"overall_status":"Completed","enrollment":" Enrollment 829","initiation":"Initiation: 06/23/2016","start_date":" 06/23/2016","primary_txt":" Primary completion: 07/05/2023","primary_completion_date":" 07/05/2023","study_txt":" Completion: 07/05/2023","study_completion_date":" 07/05/2023","last_update_posted":"2024-12-27"},{"id":"773c9389-65d5-4b78-bd5e-1b126199a8e4","acronym":"LUNG 037","url":"https://clinicaltrials.gov/study/NCT03631706","created_at":"2021-01-17T17:55:02.468Z","updated_at":"2025-02-25T16:08:13.876Z","phase":"Phase 3","brief_title":"M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer 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Cancer Institute (NCI)","biomarkers":" TMB • BRCA1 • BRCA2 • MSI • HRD","pipe":" | ","alterations":" TMB-H • MSI-H/dMMR","tags":["TMB • BRCA1 • BRCA2 • MSI • HRD"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e TMB-H • MSI-H/dMMR"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e bintrafusp alfa (M7824) • epacadostat (INCB024360) • Anktiva (nogapendekin alfa inbakicept-pmln)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 53","initiation":"Initiation: 05/01/2018","start_date":" 05/01/2018","primary_txt":" Primary completion: 12/31/2024","primary_completion_date":" 12/31/2024","study_txt":" Completion: 12/31/2024","study_completion_date":" 12/31/2024","last_update_posted":"2024-06-07"},{"id":"58c294f2-ab5b-419e-afe1-53ffc8ada05f","acronym":"","url":"https://clinicaltrials.gov/study/NCT05012098","created_at":"2021-08-19T15:53:00.327Z","updated_at":"2024-07-02T16:34:38.100Z","phase":"Phase 2","brief_title":"Phase 2 Study of Bintrafusp Alfa in Recurrent/Metastatic Olfactory Neuroblastoma (BARON).","source_id_and_acronym":"NCT05012098","lead_sponsor":"National Cancer Institute (NCI)","biomarkers":" PD-L1 • CD4","pipe":"","alterations":" ","tags":["PD-L1 • CD4"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e bintrafusp alfa (M7824)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 32","initiation":"Initiation: 06/21/2022","start_date":" 06/21/2022","primary_txt":" Primary completion: 08/31/2024","primary_completion_date":" 08/31/2024","study_txt":" Completion: 08/31/2025","study_completion_date":" 08/31/2025","last_update_posted":"2024-06-05"},{"id":"929ccfce-1289-4064-963b-ead111a6575c","acronym":"","url":"https://clinicaltrials.gov/study/NCT04835896","created_at":"2021-04-08T13:52:37.167Z","updated_at":"2024-07-02T16:35:05.912Z","phase":"Phase 1/2","brief_title":"Study of M7824 and Paclitaxel Combination as a Second-line Treatment in Patients With Recurrent/Metastatic Gastric 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Prostate Cancer","source_id_and_acronym":"NCT05445882","lead_sponsor":"National Cancer Institute (NCI)","biomarkers":" CD4","pipe":"","alterations":" ","tags":["CD4"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e bintrafusp alfa (M7824) • Anktiva (nogapendekin alfa inbakicept-pmln)"],"overall_status":"Withdrawn","enrollment":"","initiation":"Initiation: 04/01/2024","start_date":" 04/01/2024","primary_txt":" Primary completion: 04/01/2024","primary_completion_date":" 04/01/2024","study_txt":" Completion: 04/01/2024","study_completion_date":" 04/01/2024","last_update_posted":"2024-04-02"},{"id":"cdf035f3-57bf-43f0-9cb5-ab0631b1c1bf","acronym":"","url":"https://clinicaltrials.gov/study/NCT04756505","created_at":"2021-02-16T12:53:52.608Z","updated_at":"2024-07-02T16:35:25.096Z","phase":"Phase 1","brief_title":"Immunotherapy (NHS-IL12 \u0026 Bintrafusp Alfa) and Radiation Therapy for the Treatment of Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer, the REINA 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With Anti-PDL1/TGF-Beta Trap (M7824) in Subjects With HPV Associated Cancers","source_id_and_acronym":"NCT04432597 - 20-C-0104","lead_sponsor":"National Cancer Institute (NCI)","biomarkers":" CD4","pipe":" | ","alterations":" TILs","tags":["CD4"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e TILs"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e bintrafusp alfa (M7824) • PRGN-2009"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 39","initiation":"Initiation: 08/11/2020","start_date":" 08/11/2020","primary_txt":" Primary completion: 11/22/2022","primary_completion_date":" 11/22/2022","study_txt":" Completion: 11/20/2025","study_completion_date":" 11/20/2025","last_update_posted":"2023-11-27"},{"id":"022a29da-b197-4827-a622-2e8a2fce79e0","acronym":"","url":"https://clinicaltrials.gov/study/NCT04491955","created_at":"2021-01-18T21:34:47.909Z","updated_at":"2024-07-02T16:35:29.342Z","phase":"Phase 2","brief_title":"Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers","source_id_and_acronym":"NCT04491955","lead_sponsor":"National Cancer Institute (NCI)","biomarkers":" CEACAM5 • CD4","pipe":"","alterations":" ","tags":["CEACAM5 • CD4"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e bintrafusp alfa (M7824) • Anktiva (nogapendekin alfa inbakicept-pmln) • PDS01ADC • Panvac-VF (falimarev/inalimarev)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 32","initiation":"Initiation: 09/22/2020","start_date":" 09/22/2020","primary_txt":" Primary completion: 10/25/2022","primary_completion_date":" 10/25/2022","study_txt":" Completion: 01/31/2026","study_completion_date":" 01/31/2026","last_update_posted":"2023-11-14"},{"id":"ea35f30d-6ff9-4dfc-b85a-2601e3cf6973","acronym":"MS200647_0047","url":"https://clinicaltrials.gov/study/NCT03833661","created_at":"2021-01-18T18:55:43.816Z","updated_at":"2025-02-25T16:08:52.588Z","phase":"Phase 2","brief_title":"M7824 Monotherapy in Locally 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09/30/2022","last_update_posted":"2023-10-25"},{"id":"869ae534-4840-4654-8ab9-9ef5515b4d25","acronym":"MS200647_0017","url":"https://clinicaltrials.gov/study/NCT04246489","created_at":"2021-01-18T20:38:26.677Z","updated_at":"2025-02-25T16:09:54.047Z","phase":"Phase 2","brief_title":"Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer","source_id_and_acronym":"NCT04246489 - MS200647_0017","lead_sponsor":"EMD Serono Research \u0026 Development Institute, Inc.","biomarkers":" PD-L1 • CD4","pipe":" | ","alterations":" PD-L1 expression","tags":["PD-L1 • CD4"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e PD-L1 expression"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e bintrafusp alfa (M7824)"],"overall_status":"Completed","enrollment":" Enrollment 146","initiation":"Initiation: 03/30/2020","start_date":" 03/30/2020","primary_txt":" Primary completion: 04/05/2022","primary_completion_date":" 04/05/2022","study_txt":" Completion: 12/14/2022","study_completion_date":" 12/14/2022","last_update_posted":"2023-10-23"},{"id":"41194c64-5b38-487c-8d16-a9a7fa4fe5b1","acronym":"BIMES","url":"https://clinicaltrials.gov/study/NCT05005429","created_at":"2021-08-13T12:53:39.420Z","updated_at":"2024-07-02T16:35:37.791Z","phase":"Phase 2","brief_title":"Study of the Efficacy and Safety of the Bintrafusp Alfa in Previously Treated Advanced Malignant Pleural Mesothelioma","source_id_and_acronym":"NCT05005429 - BIMES","lead_sponsor":"Fundación GECP","biomarkers":" CD4","pipe":"","alterations":" ","tags":["CD4"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e bintrafusp alfa (M7824)"],"overall_status":"Recruiting","enrollment":" Enrollment 47","initiation":"Initiation: 09/20/2021","start_date":" 09/20/2021","primary_txt":" Primary completion: 03/30/2025","primary_completion_date":" 03/30/2025","study_txt":" Completion: 04/30/2025","study_completion_date":" 04/30/2025","last_update_posted":"2023-09-07"},{"id":"f6869f0c-c83e-472e-8bdd-312994ff906a","acronym":"LUNG 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07/29/2022","last_update_posted":"2023-08-21"},{"id":"16ae2e66-ff68-4b01-a372-cd9807d30a5f","acronym":"NCI-2018-00919","url":"https://clinicaltrials.gov/study/NCT03436563","created_at":"2021-01-17T17:15:39.814Z","updated_at":"2024-07-02T16:35:51.949Z","phase":"Phase 1/2","brief_title":"M7824 in Patients With Metastatic Colorectal Cancer or With Advanced Solid Tumors With Microsatellite Instability","source_id_and_acronym":"NCT03436563 - NCI-2018-00919","lead_sponsor":"M.D. Anderson Cancer Center","biomarkers":" BRAF • MSI","pipe":"","alterations":" ","tags":["BRAF • MSI"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e bintrafusp alfa (M7824)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 74","initiation":"Initiation: 03/07/2018","start_date":" 03/07/2018","primary_txt":" Primary completion: 08/01/2023","primary_completion_date":" 08/01/2023","study_txt":" Completion: 08/01/2023","study_completion_date":" 08/01/2023","last_update_posted":"2023-03-29"},{"id":"8a9b9049-bc28-43c5-9df1-3fa9583037fd","acronym":"18-C-0056","url":"https://clinicaltrials.gov/study/NCT03427411","created_at":"2021-01-29T07:16:56.930Z","updated_at":"2024-07-02T16:35:52.157Z","phase":"Phase 2","brief_title":"M7824 in Subjects With HPV Associated Malignancies","source_id_and_acronym":"NCT03427411 - 18-C-0056","lead_sponsor":"National Cancer Institute (NCI)","biomarkers":" CD4","pipe":"","alterations":" ","tags":["CD4"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e bintrafusp alfa (M7824)"],"overall_status":"Completed","enrollment":" Enrollment 57","initiation":"Initiation: 02/27/2018","start_date":" 02/27/2018","primary_txt":" Primary completion: 02/02/2021","primary_completion_date":" 02/02/2021","study_txt":" Completion: 12/31/2022","study_completion_date":" 12/31/2022","last_update_posted":"2023-03-28"},{"id":"cd45281c-e2c6-454a-a9ca-12d423994c53","acronym":"RACHEL1","url":"https://clinicaltrials.gov/study/NCT03524170","created_at":"2021-01-18T17:21:46.014Z","updated_at":"2024-07-02T16:36:15.951Z","phase":"Phase 1","brief_title":"Radiation Therapy and M7824 in Treating Patients With Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer","source_id_and_acronym":"NCT03524170 - RACHEL1","lead_sponsor":"M.D. Anderson Cancer Center","biomarkers":" HER-2","pipe":" | ","alterations":" HER-2 amplification • HER-2 negative","tags":["HER-2"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e HER-2 amplification • HER-2 negative"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e bintrafusp alfa (M7824)"],"overall_status":"Completed","enrollment":" Enrollment 24","initiation":"Initiation: 04/30/2018","start_date":" 04/30/2018","primary_txt":" Primary completion: 02/10/2022","primary_completion_date":" 02/10/2022","study_txt":" Completion: 02/10/2022","study_completion_date":" 02/10/2022","last_update_posted":"2022-03-07"},{"id":"9906ce57-7b42-4897-b075-2f4716e2e89d","acronym":"","url":"https://clinicaltrials.gov/study/NCT04648826","created_at":"2021-01-19T20:40:19.931Z","updated_at":"2024-07-02T16:36:19.361Z","phase":"Phase 1/2","brief_title":"Aerosolized Azacytidine as Epigenetic Priming for Bintrafusp Alfa-Mediated Immune Checkpoint Blockade in Patients With Unresectable Pulmonary Metastases From Sarcomas, Germ Cell Tumors, or Epithelial Malignancies","source_id_and_acronym":"NCT04648826","lead_sponsor":"National Cancer Institute (NCI)","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 azacitidine • bintrafusp alfa (M7824)"],"overall_status":"Withdrawn","enrollment":"","initiation":"Initiation: 12/14/2021","start_date":" 12/14/2021","primary_txt":" Primary completion: 12/14/2021","primary_completion_date":" 12/14/2021","study_txt":" Completion: 12/14/2021","study_completion_date":" 12/14/2021","last_update_posted":"2021-12-17"}]