Therapy Detail

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Therapy Name Bintrafusp alfa
Synonyms
Therapy Description

Bintrafusp alfa is a human PD-L1 (CD274) antibody fused with transforming growth factor-beta (TGF-beta, TGFBR2) receptor II extracellular domain, which blocks two immuno-inhibitory pathways simultaneously, therefore enhances anti-tumor immunity (PMID: 29298798, PMID: 32461347).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Bintrafusp alfa MSB0011359C|M7824 Immune Checkpoint Inhibitor 146 PD-L1/PD-1 antibody 112 TGFBR2 Antibody 3 Bintrafusp alfa is a human PD-L1 (CD274) antibody fused with transforming growth factor-beta (TGF-beta, TGFBR2) receptor II extracellular domain, which blocks two immuno-inhibitory pathways simultaneously, therefore enhances anti-tumor immunity (PMID: 29298798, PMID: 32461347).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03436563 Phase Ib/II Bintrafusp alfa M7824 in Patients With Metastatic Colorectal Cancer or With Advanced Solid Tumors With Microsatellite Instability Active, not recruiting USA 0
NCT04247282 Phase Ib/II Bintrafusp alfa Bintrafusp alfa + ETBX-011 + ETBX-051 + ETBX-061 ALT-803 + Bintrafusp alfa + ETBX-011 + ETBX-051 + ETBX-061 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 Completed USA 0
NCT04349280 Phase I Bintrafusp alfa A Study to Evaluate the Efficacy and Safety of Bintrafusp Alfa (M7824) Monotherapy in Metastatic or Locally Advanced Urothelial Cancer Active, not recruiting USA | GBR | FRA | ESP | CAN 1
NCT02517398 Phase I Bintrafusp alfa MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors Completed USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 3
NCT03707587 Phase II Bintrafusp alfa M7824 in People With Recurrent Respiratory Papillomatosis Completed USA 0
NCT04560686 Phase II Bintrafusp alfa Bintrafusp Alfa Before Surgery for the Treatment of Untreated Resectable Non-small Cell Lung Cancer Terminated USA 0
NCT04489940 Phase II Bintrafusp alfa Bintrafusp Alfa in High Mobility Group AT-Hook 2 (HMGA2) Expressing Triple Negative Breast Cancer Terminated USA | ITA | FRA | ESP | BEL 1
NCT04246489 Phase II Bintrafusp alfa Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer Completed USA | FRA | ESP | BEL | AUS 7
NCT03631706 Phase II Bintrafusp alfa Pembrolizumab 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) Active, not recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL 11
NCT05005429 Phase II Bintrafusp alfa Study of the Efficacy and Safety of the Bintrafusp Alfa in Previously Treated Advanced Malignant Pleural Mesothelioma (BIMES) Recruiting ESP 0
NCT04501094 Phase II Bintrafusp alfa A Phase II Study of Bintrafusp Alfa (M7824) in Checkpoint Inhibitor Naive and Refractory Subjects With Urothelial Carcinoma Terminated USA 0
NCT04417660 Phase II Bintrafusp alfa Bintrafusp Alfa (M7824) in Subjects With Thymoma and Thymic Carcinoma Recruiting USA 0
NCT03833661 Phase II Bintrafusp alfa M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer) Completed USA | ITA | GBR | FRA | ESP 4
NCT04708067 Phase I Bintrafusp alfa Hypofractionated Radiation Therapy and Bintrafusp Alfa for the Treatment of Advanced Intrahepatic Cholangiocarcinoma Recruiting USA 0
NCT03620201 Phase I Bintrafusp alfa M7824 in Treating Patients With Stage II-III HER2 Positive Breast Cancer Active, not recruiting USA 0
NCT04428047 Phase II Bintrafusp alfa Evaluation of Bintrafusp Alfa in Operable and Untreated Head and Neck Squamous Cell Carcinoma (ICING) Terminated FRA 0
NCT03840902 Phase II Carboplatin + Paclitaxel Bintrafusp alfa Cisplatin + Etoposide Durvalumab Bintrafusp alfa + Cisplatin + Etoposide Bintrafusp alfa + Carboplatin + Paclitaxel Bintrafusp alfa + Cisplatin + Pemetrexed Disodium Cisplatin + Pemetrexed Disodium M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) Terminated USA | FRA | ESP | DEU | CAN | BEL | AUS 8
NCT03554473 Phase Ib/II Bintrafusp alfa + Topotecan Bintrafusp alfa + Temozolomide Bintrafusp alfa M7824 and Topotecan or Temozolomide in Relapsed Small Cell Lung Cancers Recruiting USA 0
NCT04220775 Phase Ib/II Bintrafusp alfa M7824 Plus Re-irradiation With Stereotactic Body Radiation Therapy for the Curative Intent Treatment of Recurrent Head and Neck Cancer Completed USA 0
NCT03427411 Phase II Bintrafusp alfa Phase II Trial of M7824 in Subjects With HPV Positive Malignancies Completed USA 0
NCT04727541 Phase II Bintrafusp alfa Neoadjuvant Bintrafusp Alfa in Patients With Resectable Biliary Tract Cancer (NEOBIL) Terminated DEU 0
NCT05012098 Phase II Bintrafusp alfa Phase 2 Study of Bintrafusp Alfa in Recurrent/Metastatic Olfactory Neuroblastoma (BARON). Recruiting USA 0


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