| bintrafusp alfa (M7824) / EMD Serono |
LUNG 037, NCT03631706 / 2018-001517-32: 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 (NSCLC) |
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| Active, not recruiting | 3 | 304 | Europe, Canada, Japan, US, RoW | M7824, Pembrolizumab | EMD Serono Research & Development Institute, Inc., Merck KGaA, Darmstadt, Germany | Non-small Cell Lung Cancer | 06/21 | 06/24 | | |
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2021-000179-36: Bintrafusp alfa Program Rollover Study Estudio de continuación del programa Bintrafusp alfa |
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| Ongoing | 3 | 39 | Europe | M7824, Concentrate for solution for infusion | Merck KGaA, Merck KGaA | Non-small cell lung cancer (NSCLC), biliary tract cancer (BTC), cervical cancer, and triple-negative breast cancer (TNBC) Cáncer de pulmón de células no pequeñas (NSCLC), cáncer de vías biliares (BTC), cáncer de cuello uterino y cáncer de mama triple negativo (TNBC), Non-small cell lung cancer (NSCLC), biliary tract cancer (BTC), cervical cancer, and triple-negative breast cancer (TNBC) Cáncer de pulmón de células no pequeñas (NSCLC), cáncer de vías biliares (BTC), cáncer de cuello uterino y cáncer de mama triple negativo (TNBC), Diseases [C] - Cancer [C04] | | | | |
| Active, not recruiting | 3 | 32 | Europe, Japan, US, RoW | Bintrafusp alfa, M7824 | EMD Serono Research & Development Institute, Inc., Merck KGaA, Darmstadt, Germany | Lung Cancer, Cancer | 04/25 | 04/25 | | |
2019-004052-11: A phase II trial assessing Bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in a pre-operative setting for resectable and untreated head and neck squamous cell carcinoma |
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| Not yet recruiting | 2 | 59 | Europe | Bintrafusp alfa, M7824, Concentrate for solution for infusion | UNICANCER, Merck Healthcare KGaA | Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx, previously untreated, with indication of primary surgery. Patients with a diagnosis of head and neck squamous cell carcinoma (HNSCC) from unknown primary will not be enrolled., -, Diseases [C] - Cancer [C04] | | | | |
2020-002079-36: Feasability study for treatment with definitive chemoradiotherapy and bintrafusp alfa for patients with esophageal cancer (TAPESTRY) Haalbaarheidsonderzoek naar de behandeling van definitieve chemoradiotherapie en bintrafusp alfa bij patiënten met slokdarmkanker (TAPESTRY) |
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| Not yet recruiting | 2 | 52 | Europe | bintrafusp alfa, Paclitaxel, Carboplatin, Concentrate for solution for infusion, Concentrate for solution for injection/infusion, Paclitaxel, Carboplatin | Amsterdam University Medical Centers, Amsterdam University Medical Centers | Esophageal squamous cell carcinoma Plaveiselcelcarcinoom van de oesofagus, esophageal cancer slokdarmkanker, Diseases [C] - Cancer [C04] | | | | |
| Completed | 2 | 57 | US | M7824, MSB0011359C | National Cancer Institute (NCI) | Human Papilloma Virus, Cervical Cancer, Oropharyngeal Cancer, Anal Cancer, Vaginal or Penile Cancer | 02/21 | 12/22 | | |
2020-005703-39: Bintrafusp alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma. Bintrafusp alfa et doxorubicine chez les patients traités pour un sarcome avancé. |
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| Not yet recruiting | 2 | 80 | Europe | Bintrafusp alfa, DOXORUBICIN, M7824, Concentrate for solution for injection/infusion, Solution for infusion, DOXORUBICIN | Institut Bergonié, Merck Healthcare KGaA | soft-tissue sarcoma sarcomes des tissus mous, soft-tissue sarcoma sarcomes des tissus mous, Diseases [C] - Cancer [C04] | | | | |
2021-001085-37: Bintrafusp alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma. Chimiothérapie néo-adjuvante plus retifanlimab (INCMGA00012)chez les patients porteurs de sarcomes rétropéritoneaux sélectionnés : une étude randomisée de phase II. |
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| Not yet recruiting | 2 | 66 | Europe | Retifanlimab, DOXORUBICIN, HOLOXAN, INCMGA00012, Solution for infusion, Powder for infusion, DOXORUBICIN, HOLOXAN (Ifosfamide) | Institut Bergonié, Incyte Biosciences International Sarl | retroperitoneal sarcomas sarcomes rétropéritonéaux, retroperitoneal sarcomas sarcomes rétropéritonéaux, Diseases [C] - Cancer [C04] | | | | |
2020-002605-25: Neoadjuvant Bintrafusp alfa in patients with resectable biliary tract cancer (NEOBIL) Neoadjuvante Therapie mit Bintrafusp alfa bei Patienten mit operablem Krebs der Gallenwege |
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| Not yet recruiting | 2 | 24 | Europe | Bintrafusp Alfa, MSB0011359C, Infusion | AIO-Studien-gGmbH, Merck Healthcare KGaA | Treatment-naive subjects with a diagnosis of resectable biliary tract cancer, confirmed by histopathology Behandlungsnaive Patienten mit histologisch diagnostiziertem operablen Gallengangskarzinom, Subjects with a diagnosis of resectable biliary tract cancer, confirmed by histopathology Patienten mit der Diagnose eines operablem Gallengangkrebs, Diseases [C] - Cancer [C04] | | | | |
| Completed | 2 | 146 | Europe, Japan, US, RoW | Bintrafusp alfa, M7824 | EMD Serono Research & Development Institute, Inc., Merck KGaA, Darmstadt, Germany | Uterine Cervical Neoplasms | 04/22 | 12/22 | | |
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NCT04396886: Bintrafusp Alfa in Previously Treated Patients With R/M Non-keratinizing NPC |
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| Completed | 2 | 38 | RoW | Bintrafusp Alfa | The University of Hong Kong, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Nasopharyngeal Carcinoma, Recurrent Carcinoma, Metastatic Cancer, Non-keratinizing Carinoma | 09/22 | 07/23 | | |
NCT04491955: Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers |
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| Active, not recruiting | 2 | 32 | US | CV301, MSB0011359C, N-803, NHS-IL12 | National Cancer Institute (NCI) | Small Bowel Cancers, Colorectal Cancers | 10/22 | 01/26 | | |
NCT04284332: Phase II Prospective Study of Bintrafusp Alfa in Previously Treated Patients With Recurrent and Metastatic (R/M) Non-keratinizing Nasopharyngeal Carcinoma (NPC) |
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| Not yet recruiting | 2 | 37 | RoW | Bintrafusp alfa | The University of Hong Kong, Merck KGaA, Darmstadt, Germany | Nasopharyngeal Carcinoma, Immunotherapy, NPC | 01/23 | 01/23 | | |
| Terminated | 2 | 153 | Europe, Canada, Japan, US, RoW | M7824, Placebo, Durvalumab, Etoposide, Pemetrexed, Carboplatin, Paclitaxel, Cisplatin, Intensity Modulated Radiation Therapy (IMRT) | EMD Serono Research & Development Institute, Inc., Merck KGaA, Darmstadt, Germany | Non-small Cell Lung Cancer | 02/23 | 02/23 | | |
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| Not yet recruiting | 2 | 49 | NA | Bintrafusp alfa | Queen Mary University of London, Merck Healthcare KGaA | Transitional Cell Carcinoma, Bladder Cancer | 07/23 | 01/25 | | |
TAPESTRY, NCT04595149: Tapestry: Addition of TGF-β and PDL-1 Inhibition to Definitive Chemoradiation in Esophageal Squamous Cell Carcinoma |
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| Recruiting | 2 | 52 | Europe | Bintrafusp alfa, M7824 | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Neoplasm, Esophagus, Malignant Esophagus Tumor, Neoplasm, Esophageal | 11/23 | 11/28 | | |
MC1821, NCT04396535: Docetaxel With or Without Bintrafusp Alfa for the Treatment of Advanced Non-small Cell Lung Cancer |
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| Terminated | 2 | 10 | US | Bintrafusp Alfa, Anti-PDL1/TGFb Trap MSB0011359C, M7824, MSB0011359C, Docetaxel, Docecad, RP56976, Taxotere, Taxotere Injection Concentrate | Mayo Clinic, National Cancer Institute (NCI) | Advanced Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8 | 12/23 | 12/23 | | |
NCT04417660: Bintrafusp Alfa (M7824) in Subjects With Thymoma and Thymic Carcinoma |
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| Recruiting | 2 | 38 | US | M7824 | National Cancer Institute (NCI) | Thymic Epithelial Tumor, Recurrent Thymoma, Thymic Cancer | 12/24 | 01/25 | | |
NCT05145569: Antitumor Activity of Neoadjuvant Chemotherapy With or Without HCW9218 in Metastatic Advanced Stage Ovarian Cancer |
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| Recruiting | 2 | 33 | US | Carboplatin AUC 5 and paclitaxel, Carbo/Taxol, HCW9218 | Haider Mahdi, HCW Biologics | Ovarian Cancer | 05/26 | 01/28 | | |
NCT03315871: Combination Immunotherapy in Biochemically Recurrent Prostate Cancer |
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| Active, not recruiting | 2 | 40 | US | PROSTVAC-V, PROSTVAC-F, MSB0011359C (M7824), CV301 | National Cancer Institute (NCI) | Prostate Cancer | 01/25 | 01/25 | | |
NCT05012098: Phase 2 Study of Bintrafusp Alfa in Recurrent/Metastatic Olfactory Neuroblastoma (BARON). |
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| Active, not recruiting | 2 | 11 | US | Bintrafusp alfa / M7824 | National Cancer Institute (NCI) | Olfactory Neuroblastoma, Esthesioneuroblastoma, Neoplasm of the Nasal Cavity | 08/24 | 08/25 | | |
TRUST, NCT04874311: Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma |
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| Recruiting | 2 | 80 | Europe | Bintrafusp alfa, Doxorubicin | Institut Bergonié, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Advanced Soft-tissue Sarcoma, Metastatic Soft-tissue Sarcoma | 09/24 | 03/25 | | |
NCT05445882: N-803 Alone or in Combination With BN-Brachyury Vaccine or Bintrafusp Alfa (M7824) for Participants With Castration Resistant Prostate Cancer |
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| Withdrawn | 2 | 28 | US | Bintrafusp alfa, N-803, BN-Brachyury | National Cancer Institute (NCI) | Castration Resistant Prostate Cancer | 04/24 | 04/24 | | |
| Recruiting | 2 | 47 | Europe | Bintrafusp alfa, M7824 | Fundación GECP | Mesothelioma; Lung | 03/25 | 04/25 | | |
NCT04247282: Anti-PD-L1/TGF-beta Trap (M7824) Alone and in Combination With TriAd Vaccine and N-803 for Resectable Head and Neck Squamous Cell Carcinoma Not Associated With Human Papillomavirus Infection |
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| Completed | 1/2 | 21 | US | M7824, bintrafusp alfa, N803, Anktiva, TriAd vaccine, ETBX-011, ETBX-051 & ETBX-061 | National Cancer Institute (NCI) | Head and Neck Cancer, Head and Neck Neoplasms | 08/21 | 06/23 | | |
NCT04287868: Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies |
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| Active, not recruiting | 1/2 | 51 | US | PDS0101, M7824, MSB0011395C, NHS-IL12 | National Cancer Institute (NCI) | Cervical Cancer, HPV Cancers, Anal Cancer, Oropharyngeal Cancer, Vulvar, Vaginal, Penile, Rectal Cancer | 07/22 | 07/26 | | |
20-C-0104, NCT04432597: HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PDL1/TGF-Beta Trap (M7824) in Subjects With HPV Associated Cancers |
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| Active, not recruiting | 1/2 | 39 | US | PRGN-2009 (Phase I), PRGN-2009 (Phase II), M7824, MSB0011359C, MRI, Magnetic resonance imaging, Bone scan, CT scan, Computed tomography scan, Brain CT, Brain computed tomography, Brain MRI, Brain magnetic resonance imaging, Biopsy (Phase I), Biopsy (Phase II) | National Cancer Institute (NCI) | HPV Positive Cancer, Vulvar, Vaginal, Penile, Rectal Cancer, Anal Cancer, Oropharyngeal Cancer, Cervical Cancer | 11/22 | 11/25 | | |
NCT04574583: 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) |
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| Completed | 1/2 | 12 | US | SX-682, M7824, BinTrafusp Alfa, MVA-BN-CV301, modified vaccinia Ankara (MVA)-BN-CV301, recombinant fowlpox viral (FPV)-CV301 | National Cancer Institute (NCI) | Metastatic Cancer, Solid Tumors | 02/23 | 05/23 | | |
NCI-2018-00919, NCT03436563: M7824 in Patients With Metastatic Colorectal Cancer or With Advanced Solid Tumors With Microsatellite Instability |
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| Active, not recruiting | 1/2 | 74 | US | Anti-PD-L1/TGFbetaRII Fusion Protein M7824, Anti-PDL1/TGFb Trap MSB0011359C, M7824, MSB0011359C, Bintrafusp Alfa | M.D. Anderson Cancer Center, National Cancer Institute (NCI) | Colon Adenocarcinoma, High-Frequency Microsatellite Instability, Metastatic Malignant Solid Neoplasm, Rectal Adenocarcinoma, Refractory Colorectal Carcinoma, Stage IV Colon Cancer AJCC v8, Stage IV Rectal Cancer AJCC v8, Stage IVA Colon Cancer AJCC v8, Stage IVA Rectal Cancer AJCC v8, Stage IVB Colon Cancer AJCC v8, Stage IVB Rectal Cancer AJCC v8 | 08/23 | 08/23 | | |
QuEST1, NCT03493945: Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat |
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| Active, not recruiting | 1/2 | 53 | US | M7824, N-803, MVA-BN-Brachyury, FPV-Brachyury, Epacadostat | National Cancer Institute (NCI) | Metastatic Prostate Cancer, Prostate Cancer, Prostate Neoplasm, Advanced Solid Tumor, Solid Tumor | 12/24 | 12/24 | | |
21-C-0001, NCT04633252: M9241 in Combination With Docetaxel in Adults With Metastatic Castration Sensitive and Castration Resistant Prostate Cancer |
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| Recruiting | 1/2 | 86 | US | ADT, Prednisone, M7824, Docetaxel, M9241 | National Cancer Institute (NCI) | Cancer Of Prostate, Prostate Neoplasms | 12/24 | 12/24 | | |
NCT03554473: M7824 and Topotecan or Temozolomide in Relapsed Small Cell Lung Cancers |
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| Recruiting | 1/2 | 80 | US | M7824, Topotecan, Temozolomide | National Cancer Institute (NCI) | Carcinoma, Small Cell, Lung Cancer, Small Cell Lung Cancer | 01/25 | 01/25 | | |
NCT04708470: A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers |
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| Recruiting | 1/2 | 107 | US | Bintrafusp Alfa, NHS-IL12, Entinostat | National Cancer Institute (NCI) | Oropharyngeal Cancer, Neck Cancer, Human Papillomavirus, HPV, Anal Cancer, Cervical Cancer, Penile Cancer, Vulvar Cancer, Vaginal Cancer, Colon Cancer | 06/24 | 12/25 | | |
NCT04835896: Study of M7824 and Paclitaxel Combination as a Second-line Treatment in Patients With Recurrent/Metastatic Gastric Cancer |
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| Completed | 1/2 | 49 | RoW | M7824+paclitaxel | Yonsei University | Recurrent/Metastatic Gastric Cancer | 10/23 | 10/23 | | |
NCT04789668: Bintrafusp Alfa and Pimasertib for the Treatment of Patients With Brain Metastases |
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| Completed | 1/2 | 8 | US | Bintrafusp Alfa, Anti-PDL1/TGFb Trap MSB0011359C, M7824, MSB0011359C, Pimasertib, AS703026, EMD 1036239, MSC1936369, Quality-of-Life Assessment, Quality of Life Assessment | M.D. Anderson Cancer Center | Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Hematopoietic and Lymphoid Cell Neoplasm, Hormone Receptor Positive Breast Adenocarcinoma, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Solid Neoplasm, Metastatic Melanoma, Metastatic Triple-Negative Breast Carcinoma, Pathologic Stage IV Cutaneous Melanoma AJCC v8, Prognostic Stage IV Breast Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8 | 12/23 | 12/23 | | |
NCT04303117: NHS-IL12 Monotherapy and in Combination With M7824 in Advanced Kaposi Sarcoma |
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| Recruiting | 1/2 | 64 | US | NHS-IL12, M7824 | National Cancer Institute (NCI) | Kaposi Sarcoma | 09/25 | 12/28 | | |
NCT04349280: A Study to Evaluate the Efficacy and Safety of Bintrafusp Alfa (M7824) Monotherapy in Metastatic or Locally Advanced Urothelial Cancer |
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| Terminated | 1 | 25 | Europe, Canada, US | Bintrafusp alfa | GlaxoSmithKline, Merck KGaA, Darmstadt, Germany | Neoplasms | 08/22 | 08/22 | | |
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| Completed | 1 | 58 | Canada, US | M6223, Bintrafusp alfa | EMD Serono Research & Development Institute, Inc., Merck KGaA, Darmstadt, Germany | Metastatic Solid Tumors | 06/23 | 06/23 | | |
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INDUCE-1, NCT02723955: Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors |
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| Completed | 1 | 829 | Europe, Canada, Japan, US, RoW | feladilimab (GSK3359609), GSK3174998, Pembrolizumab, Docetaxel, Pemetrexed, Paclitaxel plus Carboplatin, Gemcitabine plus Carboplatin, Fluorouracil (5-FU) plus carboplatin or cisplatin, Dostarlimab, Cobolimab, Bintrafusp alfa | GlaxoSmithKline, Merck Sharp & Dohme LLC | Neoplasms | 07/23 | 07/23 | | |
20-C-0012, NCT04235777: Bintrafusp Alfa (M7824) and NHS-IL12 (M9241) Alone and in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Metastatic Non-Prostate Genitourinary Malignancies |
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| Recruiting | 1 | 100 | US | M7824, M9241, Stereotactic body radiation therapy (SBRT) | National Cancer Institute (NCI) | Urothelial Cancer, Bladder Cancer, Genitourinary Cancer, Urogenital Neoplasms, Urogenital Cancer | 12/24 | 12/24 | | |
| Active, not recruiting | 1 | 20 | US | Bintrafusp Alfa, Anti-PDL1/TGFb Trap MSB0011359C, M7824, MSB0011359C | M.D. Anderson Cancer Center, National Cancer Institute (NCI) | Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8 | 12/24 | 12/24 | | |
NCT04708067: Hypofractionated Radiation Therapy and Bintrafusp Alfa for the Treatment of Advanced Intrahepatic Cholangiocarcinoma |
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| Active, not recruiting | 1 | 15 | US | Bintrafusp Alfa, Anti-PDL1/TGFb Trap MSB0011359C, M7824, MSB0011359C, Biopsy, BIOPSY_TYPE, Bx, Hypofractionated Radiation Therapy, Hypofractionated Radiotherapy, hypofractionation | M.D. Anderson Cancer Center | Locally Advanced Intrahepatic Cholangiocarcinoma, Metastatic Intrahepatic Cholangiocarcinoma, Stage III Intrahepatic Cholangiocarcinoma AJCC v8, Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8, Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8, Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 | 02/27 | 02/27 | | |
TAPESTRY, NCT04481256: TGF-β And PDL-1 Inhibition in Esophageal Squamous Cell Carcinoma Combined With Chemoradiation TheRapY |
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| Recruiting | N/A | 49 | Europe | External beam radiotherapy, Bintrafusp alfa, Paclitaxel, Carboplatin | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), UMC Utrecht, Catharina Ziekenhuis Eindhoven, Verbeeten Insituut Tilburg, Elisabeth-TweeSteden Ziekenhuis, Leiden University Medical Center, Radiotherapeutic Institute Friesland, Medisch Centrum Leeuwarden, Radiotherapy Group Deventer, Deventer Ziekenhuis, Rijnstate Hospital, Erasmus Medical Center, The Netherlands Cancer Institute, Maastro Clinic, The Netherlands, Zuyderland Medisch Centrum, Isala, University Medical Center Groningen, ZGT | Carcinoma, Squamous Cell, Oesophageal Cancer | 06/23 | 06/23 | | |
NCT04267861: M7824 Related Adverse Effects in Adults With Cancer |
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| Active, not recruiting | N/A | 232 | US | | National Cancer Institute (NCI) | Neoplasms, Skin Neoplasms | 11/24 | 11/24 | | |
