Table 2.
Active bintrafusp alfa studies
| Trial name | NCT | Phase | Estimated enrollment | Bintrafusp alfa dose | Combined with | Status | Target population | Location(s) |
|---|---|---|---|---|---|---|---|---|
| Bintrafusp Alfa in Previously Treated Patients With Recurrent and Metastatic (R/M) Non-keratinizing Nasopharyngeal Carcinoma (NPC) | NCT04396886 | II | 37 | N/A | N/A | Recruiting | Recurrent and metastatic non-keratinizing nasopharyngeal carcinoma | Hong Kong |
| Study of the Efficacy and Safety of the Bintrafusp Alfa in Previously Treated Advanced Malignant Pleural Mesothelioma (BIMES) | NCT05005429 | II | 47 | 1200 mg Q2W | N/A | Not yet recruiting | Mesothelioma, lung | Spain |
| A Study to Evaluate the Efficacy and Safety of Bintrafusp Alfa (M7824) Monotherapy in Metastatic or Locally Advanced Urothelial Cancer | NCT04349280 | I | 40 | 1200 mg Q2W | N/A | Recruiting | Metastatic or locally advanced urothelial cancer | USA, Canada, France, Netherlands, Spain, United Kingdom |
| Neoadjuvant Bintrafusp Alfa in Patients With Resectable Biliary Tract Cancer (NEOBIL) | NCT04727541 | II | 24 | 1200 mg Q2W | Surgery | Recruiting | Biliary tract cancer, cholangiocarcinoma | Germany |
| Evaluation of Bintrafusp Alfa in Operable and Untreated Head and Neck Squamous Cell Carcinoma (ICING) | NCT04428047 | II | 59 | 1200 mg Q2W | N/A | Recruiting | Squamous cell carcinoma of head and neck | France |
| Docetaxel With or Without Bintrafusp Alfa for the Treatment of Advanced Non-small Cell Lung Cancer | NCT04396535 | II | 80 | N/A | Docetaxel | Recruiting | Advanced non-small cell lung carcinoma | USA |
| Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma (TRUST) | NCT04874311 | II | 80 | 2400 mg Q3W | Doxorubicin | Not yet recruiting | Soft-tissue sarcoma | France |
| Bintrafusp Alfa in High Mobility Group AT-Hook 2 (HMGA2) Expressing Triple Negative Breast Cancer | NCT04489940 | II | 29 | 1200 mg Q2W | N/A | Recruiting | HMGA2-expressing triple negative breast cancer | USA, Belgium, France, Italy, Russian Federation, Spain |
| Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer | NCT04246489 | II | 146 | 1200 mg Q2W | N/A | Active, not recruiting | Uterine and cervical neoplasms | USA, Argentina, Australia, Belgium, Brazil, China, France, Hungary, Japan, Republic of Korea, Russian Federation, Spain |
| Preoperative Bintrafusp Alfa in Operable Urothelial Carcinoma of the Bladder (PEBBLE) | NCT04878250 | II | 49 | 1200 mg Q2W | N/A | Not yet recruiting | Bladder cancer | United Kingdom |
| 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 | NCT04648826 | I, II | 42 | 2400 mg Q3W | Azacytidine (aerosolized) | Not yet recruiting | Unresectable pulmonary metastases from sarcomas, germ cell tumors, or epithelial malignancies | USA |
| Bintrafusp Alfa Before Surgery for the Treatment of Untreated Resectable Non-small Cell Lung Cancer | NCT04560686 | II | 23 | N/A | Surgery | Recruiting | Resectable non-small cell lung carcinoma | USA |
| Phase 2 Study of Bintrafusp Alfa in Recurrent/Metastatic Olfactory Neuroblastoma (BARON) | NCT05012098 | II | 32 | 1200 mg Q2W | N/A | Not yet recruiting | Olfactory neuroblastoma | USA |
| Phase I/II Trial of the Combination of Bintrafusp Alfa (M7824), Entinostat and NHS-IL12 (M9241) in Patients With Advanced Cancer | NCT04708470 | I, II | 70 | 1200 mg Q2W | Entinostat and NHS-IL12 (M9241) | Recruiting | Checkpoint refractory HPV associated malignancies and MSS small bowel or colorectal cancer | USA |
| Bintrafusp Alfa and Pimasertib for the Treatment of Patients With Brain Metastases | NCT04789668 | I, II | 36 | N/A | Pimasertib | Recruiting | Intracranial metastases | USA |
| A Phase II Study of Bintrafusp Alfa (M7824) in Checkpoint Inhibitor Naive and Refractory Subjects With Urothelial Carcinoma | NCT04501094 | II | 75 | 1200 mg Q2W | N/A | Recruiting | Urothelial cancer | USA |
| Hypofractionated Radiation Therapy and Bintrafusp Alfa for the Treatment of Advanced Intrahepatic Cholangiocarcinoma | NCT04708067 | I | 15 | N/A | Hypofractionated radiation | Not yet recruiting | Intrahepatic cholangiocarcinoma | USA |
| Bintrafusp Alfa Combination Therapy in Participants With Cervical Cancer (INTR@PID 046) | NCT04551950 | I | 25 | N/A | Cisplatin/carboplatin, paclitaxel, bevacizumab | Active, not recruiting | Cervical cancer | USA, Japan, Spain |
| Bintrafusp Alfa With Pemetrexed and Platinum-Based Chemotherapy for the Treatment of Locally Advanced or Metastatic Tyrosine Kinase Inhibitor-Resistant EGFR-Mutant Non-small Cell Lung Cancer | NCT04971187 | II | 40 | N/A | Cisplatin/carboplatin, pemetrexed | Recruiting | Non-squamous EGFR-mutant non-small cell lung carcinoma | USA |
| Bintrafusp Alfa (M7824) in Subjects With Thymoma and Thymic Carcinoma | NCT04417660 | II | 38 | 1200 mg Q2W | N/A | Recruiting | Thymoma and thymic carcinoma | USA |
| Tapestry: Addition of TGF-β and PDL-1 Inhibition to Definitive Chemoradiation in Esophageal Squamous Cell Carcinoma (TAPESTRY) | NCT04595149 | II | 52 | 2400 mg Q3W | XBRT, paclitaxel, and carboplatin | Recruiting | Esophageal squamous cell carcinoma | Netherlands |
| Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L Biliary Tract Cancer (BTC) | NCT04066491a | II, III | 512 | 2400 mg Q3W | Gemcitabine, cisplatin | Recruitinga | Locally advanced or metastatic biliary tract cancer | USA, Argentina, Australia, Belgium, Brazil, Chile, China, France, Germany, Italy, Japan, Republic of Korea, Poland, Spain, Taiwan, United Kingdom |
| First in Human Study of M6223 | NCT04457778 | I | 35 | N/A | M6223 (TIGIT inhibitor) | Recruiting | Metastatic or locally advanced solid unresectable tumors | USA, Canada |
| TGF-β And PDL-1 Inhibition in Esophageal Squamous Cell Carcinoma Combined With Chemoradiation Therapy (TAPESTRY) | NCT04481256 | Non-randomized feasibility study | 49 | 2400 mg Q3W | Carboplatin, paclitaxel, radiation | Recruiting | Squamous cell carcinoma of the esophagus or gastroesophageal junction | Netherlands |
| Immunotherapy (NHS-IL12 & Bintrafusp Alfa) and Radiation Therapy for the Treatment of Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer, the REINA Trial | NCT04756505 | I | 20 | N/A | Immunocytokine NHS-IL12, radiation | Not yet recruiting | HR+/HER2- metastatic breast cancer | USA |
| Bintrafusp Alfa and Stereotactic Body Radiation Therapy for the Treatment of Recurrent or Second Primary Head and Neck Squamous Cell Cancer | NCT04220775 | I, II | 21 | N/A | SBRT | Recruiting | Recurrent head and neck squamous cell carcinoma | USA |
| 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) | NCT04574583 | I, II | 105 | 1200 mg Q2W | SX-682 (CXCR1/2 inhibitor), BN-CV301 TRICOM (CEA/MUC1) vaccines | Recruiting | Advanced solid tumors | USA |
| Bintrafusp Alfa (M7824) and M9241 in Combination With Docetaxel in Adults With Metastatic Castration Sensitive and Castration Resistant Prostate Cancer | NCT04633252 | I, II | 86 | 2400 mg Q3W | Immunocytokine NHS-IL12, Docetaxel | Recruiting | Metastatic castration sensitive and castration resistant prostate cancer | USA |
| 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 | NCT04235777 | I | 66 | 1200 mg Q2W | Immunocytokine NHS-IL12, SBRT | Recruiting | Metastatic non-prostate genitourinary malignancies | USA |
| M7824 and Eribulin Mesylate in Treating Patients With Metastatic Triple Negative Breast Cancer | NCT03579472 | I | 20 | N/A | Eribulin mesylate (microtubule-targeting agent) | Recruiting | Metastatic triple negative breast cancer | USA |
| 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) | NCT03631706 | III | 584 | 1200 mg Q2W | N/A | Discontinued, closed after DSMB assessment unlikely to hit co-primary endpoint: PFS | PD-L1-expressing advanced non-small cell lung cancer | USA, Argentina, Belgium, Brazil, Canada, China, France, Germany, Greece, Hong Kong, Italy, Japan, Republic of Korea, Netherlands, Spain, Taiwan, Turkey, Ukraine |
| M7824 in Treating Patients With Stage II-III HER2 Positive Breast Cancer | NCT03620201 | I | 20 | N/A | Neoadjuvant chemotherapy | Recruiting | Stage II-III HER2 positive breast cancer | USA |
| M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer) | NCT03833661 | II | 159 | 1200 mg Q2W | N/A | Active, not recruiting | Advanced or metastatic biliary tract cancer | USA, China, France, Italy, Japan, Republic of Korea, Spain, Taiwan, United Kingdom |
| Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1) | NCT02723955 | I | 828 | N/A | Feladilimab (Inducible T cell Co-Stimulator [ICOS] receptor agonist) | Active, not recruiting | Advanced solid tumors | USA, Australia, Canada, China, France, Italy, Japan, Netherlands, Spain |
| Bioimaging Study of 89Zr-M7824 in NSCLC | NCT04297748 | I, II | 12 | 1200 mg Q2W | 89Zirconium-M7824 | Recruiting | Non-small cell lung cancer | Australia |
| Study of M7824 and Paclitaxel Combination as a Second-line Treatment in Patients With Recurrent/Metastatic Gastric Cancer | NCT04835896 | I, II | 49 | 1200 mg Q3W | Paclitaxel | Not yet recruiting | Metastatic or locally advanced HER2 negative gastric cancer | Republic of Korea |
| Radiation Therapy and M7824 in Treating Patients With Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer | NCT03524170 | I | 24 | N/A | Radiation | Active, not recruiting | HR+/HER2- metastatic breast cancer | USA |
| BN-Brachyury, Entinostat, Adotrastuzumab Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT) | NCT04296942 | I | 65 | 1800 mg Q3W | MVA-BN-Brachyury (vaccine), TRICOM, ado-trastuzumab emtansine, entinostat | Recruiting | Triple negative breast cancer or ER-/PR-/HER2+ breast cancer | USA |
| M7824 in Patients With Metastatic Colorectal Cancer or With Advanced Solid Tumors With Microsatellite Instability | NCT03436563 | I, II | 74 | N/A | N/A | Recruiting | Colorectal cancer (or other solid tumors with microsatellite instability) | USA |
| MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors | NCT02517398 | I | 600 | N/A | N/A | Active, not recruiting | Metastatic or locally advanced solid tumors | USA, Australia, Belgium, Canada, France, Germany, Italy, Japan, Republic of Korea, Spain, Taiwan, United Kingdom |
| M7824 in Combination With Chemotherapy in Stage IV Non-small Cell Lung Cancer (NSCLC) | NCT03840915a | I, II | 70 | 2400 mg Q3W | Cisplatin, carboplatin, pemetrexed, paclitaxel or Nab-paclitaxel, gemcitabine, docetaxel | Active, not recruitinga | Stage IV non-small cell lung cancer | USA, Belgium, France |
| M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) | NCT03840902b | II | 350 | 1200 mg Q2W | Cisplatin, carboplatin, pemetrexed, paclitaxel, etoposide, durvalumab | Recruitingb | Unresectable stage III non-small cell lung cancer | USA, Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Japan, Republic of Korea, Netherlands, Spain, Taiwan |
M7824 = Bintrafusp alfa
DSMB Data Safety Monitoring Board, HPV human papillomavirus, MSS microsatellite stable, N/A not applicable, PFS progression-free survival, Q2W every 2 weeks, Q3W every 3 weeks
aStudy discontinued by sponsor as unlikely to meet primary endpoint as reviewed by an independent data monitoring committee (study status is as listed on ClinicalTrials.gov as of October 1, 2021)
bSponsor discontinued as a low likelihood that the experimental arm would achieve superiority in efficacy versus standard of care treatment (study status is as listed on ClinicalTrials.gov as of October 1, 2021)