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Bintrafusp alfa (M7824) 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).
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|M7824||Bintrafusp alfa|MSB0011359C||Immune Checkpoint Inhibitor 94 PD-L1/PD-1 antibody 65 TGFBR2 Antibody 2||Bintrafusp alfa (M7824) 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).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Unknown unknown||biliary tract cancer||not applicable||M7824||Phase I||Actionable||In a Phase I trial, Bintrafusp alfa (M7824) treatment in patients with advanced biliary tract cancer resulted in an objective response rate of 20% (6/30), including two complete responses and four partial responses, and led to an additional six patients demonstrating stable disease, and median progression-free survival of 2.5 months, and median overall survival of 12.7 months (PMID: 32461347; NCT02699515).||32461347|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status|
|NCT03833661||Phase II||M7824||M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)||Active, not recruiting|
|NCT03554473||Phase Ib/II||M7824 + Topotecan M7824 + Temozolomide M7824||M7824 and Topotecan or Temozolomide in Relapsed Small Cell Lung Cancers||Recruiting|
|NCT03427411||Phase II||M7824||Phase II Trial of M7824 in Subjects With HPV Positive Malignancies||Recruiting|
|NCT04417660||Phase II||M7824||Bintrafusp Alfa (M7824) in Subjects With Thymoma and Thymic Carcinoma||Recruiting|
|NCT04220775||Phase Ib/II||M7824||M7824 Plus Re-irradiation With Stereotactic Body Radiation Therapy for the Curative Intent Treatment of Recurrent Head and Neck Cancer||Recruiting|
|NCT04246489||Phase II||M7824||Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer||Recruiting|
|NCT02517398||Phase I||M7824||MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors||Active, not recruiting|
|NCT04247282||Phase Ib/II||M7824 ETBX-011 + ETBX-051 + ETBX-061 + M7824 ALT-803 + ETBX-011 + ETBX-051 + ETBX-061 + M7824||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||Recruiting|
|NCT03436563||Phase Ib/II||M7824||M7824 in Patients With Metastatic Colorectal Cancer or With Advanced Solid Tumors With Microsatellite Instability||Recruiting|
|NCT03707587||Phase II||M7824||M7824 in People With Recurrent Respiratory Papillomatosis||Active, not recruiting|
|NCT04349280||Phase I||M7824||A Study to Evaluate the Efficacy and Safety of Bintrafusp Alfa (M7824) Monotherapy in Metastatic or Locally Advanced Urothelial Cancer||Not yet recruiting|
|NCT03620201||Phase I||M7824||M7824 in Treating Patients With Stage II-III HER2 Positive Breast Cancer||Recruiting|
|NCT04489940||Phase II||M7824||Bintrafusp Alfa in High Mobility Group AT-Hook 2 (HMGA2) Expressing Triple Negative Breast Cancer||Not yet recruiting|
|NCT03631706||Phase II||M7824 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)||Recruiting|
|NCT03840902||Phase II||Carboplatin + Paclitaxel M7824 Cisplatin + Etoposide Durvalumab Cisplatin + Etoposide + M7824 Carboplatin + M7824 + Paclitaxel Cisplatin + M7824 + Pemetrexed Disodium Cisplatin + Pemetrexed Disodium||M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)||Recruiting|