Bintrafusp alfa

Generic Name: Bintrafusp alfa

Drug Type: Biotech

CAS Number: 1918149-01-5

Unique Ingredient Identifier: NW9K8C1JN3

Background: Bintrafusp alfa is under investigation in clinical trial NCT03833661 (M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)).

Clinical Trials

Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer

Phase 2

Completed

Conditions: Uterine Cervical Neoplasms

Interventions: Drug: Bintrafusp alfa

First Posted Date: 2020-01-29

Last Posted Date: 2023-10-23

Lead Sponsor: EMD Serono Research & Development Institute, Inc.

Target Recruit Count: 146

Registration Number: NCT04246489

Locations: 🇺🇸
The Stamford Hospital, Stamford, Connecticut, United States
🇺🇸
Karmanos Cancer Institute, Farmington Hills, Michigan, United States
🇺🇸
Comprehensive Cancer Centers of Nevada, Henderson, Nevada, United States

and more 70 locations

Bintrafusp Alfa (M7824) and PDS01ADC Alone and in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Metastatic Non-Prostate Genitourinary Malignancies

Phase 1

Recruiting

Conditions: Urothelial Cancer
Genitourinary Cancer
Urogenital Neoplasms
Bladder Cancer
Urogenital Cancer

Interventions: Drug: PDS01ADC
Radiation: Stereotactic body radiation therapy (SBRT)
Drug: M7824

First Posted Date: 2020-01-22

Last Posted Date: 2025-05-16

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 100

Registration Number: NCT04235777

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Bintrafusp Alfa and Stereotactic Body Radiation Therapy for the Treatment of Recurrent or Second Primary Head and Neck Squamous Cell Cancer

Phase 1

Terminated

Conditions: Recurrent Head and Neck Squamous Cell Carcinoma
Second Primary Squamous Cell Carcinoma of the Head and Neck

Interventions: Drug: Bintrafusp Alfa
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Radiation: Stereotactic Body Radiation Therapy

First Posted Date: 2020-01-07

Last Posted Date: 2024-11-07

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 3

Registration Number: NCT04220775

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC

Phase 2

Terminated

Conditions: Cholangiocarcinoma
Gallbladder Cancer
Biliary Tract Cancer

Interventions: Drug: M7824
Drug: Placebo
Drug: Gemcitabine
Drug: Cisplatin

First Posted Date: 2019-08-26

Last Posted Date: 2023-11-14

Lead Sponsor: EMD Serono Research & Development Institute, Inc.

Target Recruit Count: 309

Registration Number: NCT04066491

Locations: 🇺🇸
Methodist Transplant Physicians, Dallas, Texas, United States
🇺🇸
MD Anderson Cancer Center - Unit 429, Houston, Texas, United States
🇺🇸
Renovatio Clinical - CENTRAL SITE, The Woodlands, Texas, United States

and more 96 locations

M7824 in Combination With Chemotherapy in Stage IV Non-small Cell Lung Cancer (NSCLC)

Phase 1

Completed

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: Cisplatin
Drug: Docetaxel
Drug: Nab-paclitaxel
Drug: Carboplatin
Drug: Gemcitabine
Drug: Bintrafusp alfa
Drug: Pemetrexed
Drug: M7824
Drug: Paclitaxel

First Posted Date: 2019-02-15

Last Posted Date: 2023-08-21

Lead Sponsor: EMD Serono Research & Development Institute, Inc.

Target Recruit Count: 70

Registration Number: NCT03840915

Locations: 🇺🇸
Compassionate Care Research Group Inc - Edinger Medical Group, Inc., Fountain Valley, California, United States
🇺🇸
RCCA MD LLC - Bethesda, Bethesda, Maryland, United States
🇺🇸
University of Maryland - DUPLICATE/Pediatric Surgery, Baltimore, Maryland, United States

and more 16 locations

M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)

Phase 2

Terminated

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: M7824
Drug: Placebo
Drug: Durvalumab
Drug: Etoposide
Drug: Pemetrexed
Drug: Carboplatin
Drug: Paclitaxel
Drug: Cisplatin
Radiation: Intensity Modulated Radiation Therapy (IMRT)

First Posted Date: 2019-02-15

Last Posted Date: 2024-01-16

Lead Sponsor: EMD Serono Research & Development Institute, Inc.

Target Recruit Count: 153

Registration Number: NCT03840902

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center - Unit 432 Thoracic Head and Neck Medical Oncology, Houston, Texas, United States
🇺🇸
Lynn Cancer Institute Center, Boca Raton, Florida, United States
🇺🇸
American Health Network of Indiana, LLC, Indianapolis, Indiana, United States

and more 101 locations

M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)

Phase 2

Completed

Conditions: Cholangiocarcinoma
Gallbladder Cancer
Biliary Tract Cancer

Interventions: Drug: M7824

First Posted Date: 2019-02-07

Last Posted Date: 2023-10-25

Lead Sponsor: EMD Serono Research & Development Institute, Inc.

Target Recruit Count: 159

Registration Number: NCT03833661

Locations: 🇺🇸
MD Anderson Cancer Center - Unit, Houston, Texas, United States
🇯🇵
Kindai University Hospital - Dept of Gastroenterology, Osakasayama-shi, Japan
🇪🇸
Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

and more 30 locations

M7824 in People With Recurrent Respiratory Papillomatosis

Phase 2

Completed

Conditions: Human Papilloma Virus
Recurrent Respiratory Papillomatosis
Respiratory Papillomatosis
Laryngeal Papilloma, Recurrent

Interventions: Drug: M7824

First Posted Date: 2018-10-16

Last Posted Date: 2022-09-29

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 9

Registration Number: NCT03707587

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

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)

Phase 3

Completed

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: M7824
Drug: Pembrolizumab

First Posted Date: 2018-08-15

Last Posted Date: 2025-04-08

Lead Sponsor: EMD Serono Research & Development Institute, Inc.

Target Recruit Count: 304

Registration Number: NCT03631706

Locations: 🇺🇸
Cedars Sinai Medical Center - Inflammatory Bowel Disease Center (Clinic, Los Angeles, California, United States
🇺🇸
Decatur Memorial Hospital - Clinical Research, Decatur, Illinois, United States
🇺🇸
UPMC Cancer Center, Pittsburgh, Pennsylvania, United States

and more 116 locations

M7824 in Treating Patients With Stage II-III HER2 Positive Breast Cancer

Phase 1

Completed

Conditions: Anatomic Stage IIIA Breast Cancer AJCC v8
Prognostic Stage IIIB Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage IIIC Breast Cancer AJCC v8
Prognostic Stage III Breast Cancer AJCC v8
Prognostic Stage IIA Breast Cancer AJCC v8
Prognostic Stage IIIA Breast Cancer AJCC v8
Prognostic Stage IIIC Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8

Interventions: Drug: Bintrafusp Alfa

First Posted Date: 2018-08-08

Last Posted Date: 2024-10-22

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 20

Registration Number: NCT03620201

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

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