Drugs / Bintrafusp alfa
last change Jul 2026 re-read 2 minutes ago

Bintrafusp alfa

also known as M7824 · MSB0011359C · 8L9YQ2N6PA

Protein / enzyme biologic targets CD274

Developed for
non-small cell lung carcinoma · cervical cancer · female breast carcinoma · triple-negative breast carcinoma · anal carcinoma · cholangiocarcinoma · human papilloma virus infection · metastatic malignant neoplasm
+50 more · cancer · castration-resistant prostate carcinoma · gallbladder cancer · head and neck squamous cell carcinoma · hormone receptor-positive breast cancer · neoplasm · oropharyngeal carcinoma · oropharynx cancer · pancreatic adenocarcinoma · urinary bladder cancer · urothelial carcinoma · anus cancer · breast carcinoma · carcinoma · colon adenocarcinoma · colorectal cancer · cutaneous melanoma · esophageal cancer · esthesioneuroblastoma · germ cell tumor · head and neck cancer · hematopoietic and lymphoid cell neoplasm · HER2 positive breast carcinoma · intrahepatic cholangiocarcinoma · Kaposi's sarcoma · laryngeal papillomatosis · lung cancer · malignant pleural mesothelioma · melanoma · metastatic malignant neoplasm in the brain · metastatic melanoma · metastatic neoplasm · nasal cavity neoplasm · nasopharyngeal carcinoma · nasopharyngeal type undifferentiated carcinoma · olfactory neuroblastoma · penile cancer · prostate cancer · rectum adenocarcinoma · sarcoma · small cell lung carcinoma · small intestine cancer · soft tissue sarcoma · squamous cell carcinoma · thymoma · thymus cancer · transitional cell carcinoma · vaginal cancer · virus associated tumor · vulva cancer
Investigated by
National Cancer Institute (NCI) · Merck KGaA, Darmstadt, Germany · EMD Serono Research & Development Institute, Inc. · M.D. Anderson Cancer Center · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · GlaxoSmithKline
+29 more · AIO-Studien-gGmbH · Academic Medical Center - University of Amsterdam · Austin Health · Catharina Ziekenhuis Eindhoven · Deventer Ziekenhuis · Elisabeth-TweeSteden Ziekenhuis · Erasmus Medical Center · Frisius Medisch Centrum · Fundación GECP · Institut Bergonié · Institute Verbeeten · Isala · Leiden University Medical Center · Mayo Clinic · Merck Healthcare KGaA · Merck Serono GmbH, Germany · Merck Sharp & Dohme LLC · Olivia Newton-John Cancer Research Institute · Queen Mary University of London · Radiotherapeutic Institute Friesland · Radiotherapy Group Deventer · Rijnstate Hospital · The Netherlands Cancer Institute · The University of Hong Kong · UMC Utrecht · UNICANCER · University Medical Center Groningen · Yonsei University · Ziekenhuisgroep Twente

Trials 55 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 113 trials
Phase 1 NCT04708067 Aug 2021 → Feb 2027 expected intrahepatic cholangiocarcinoma M.D. Anderson Cancer Center Active not recruiting No outcome recorded
Phase 1 NCT04296942 May → Oct 2021 HER2 positive breast carcinoma, triple-negative breast carcinoma National Cancer Institute (NCI) Terminated No outcome recorded
Phase 1 NCT04756505 Mar 2021 → Feb 2022 female breast carcinoma, hormone receptor-positive breast cancer M.D. Anderson Cancer Center Withdrawn No outcome recorded
Phase 1 NCT04551950 Oct 2020 → Jun 2022 cervical cancer EMD Serono Research & Development Institute, Inc. Completed No outcome recorded
Phase 1 NCT04349280 Oct 2020 → Aug 2022 neoplasm GlaxoSmithKline Terminated No outcome recorded
Phase 1 NCT04235777 Jul 2020 → Dec 2027 expected urinary bladder cancer, urothelial carcinoma National Cancer Institute (NCI) Recruiting No outcome recorded
Phase 1 NCT04457778 Jul 2020 → Jun 2023 metastatic neoplasm EMD Serono Research & Development Institute, Inc. Completed No outcome recorded
Phase 1 NCT03620201 Aug 2018 → Oct 2024 female breast carcinoma M.D. Anderson Cancer Center Completed No outcome recorded
Phase 1 NCT03579472 May 2018 → Sep 2022 female breast carcinoma, triple-negative breast carcinoma M.D. Anderson Cancer Center Terminated No outcome recorded
Phase 1 NCT03524170 Apr 2018 → Feb 2022 breast carcinoma M.D. Anderson Cancer Center Completed No outcome recorded
Phase 1/217 trials
Phase 1/2 NCT04648826 Dec 2021 carcinoma, germ cell tumor, melanoma, sarcoma National Cancer Institute (NCI) Withdrawn No outcome recorded
Phase 1/2 NCT04708470 Oct 2021 → Nov 2026 expected anus cancer, cervical cancer, human papilloma virus infection, oropharyngeal carcinoma +3 National Cancer Institute (NCI) Active not recruiting No outcome recorded
Phase 1/2 NCT04327986 Jun 2021 → Jan 2022 pancreatic adenocarcinoma National Cancer Institute (NCI) Terminated No outcome recorded
Phase 1/2 NCT04835896 Jun 2021 → Oct 2023 Yonsei University Completed No outcome recorded
Phase 1/2 NCT04789668 Jan 2021 → Dec 2023 cutaneous melanoma, female breast carcinoma, hematopoietic and lymphoid cell neoplasm, hormone receptor-positive breast cancer +4 M.D. Anderson Cancer Center Terminated No outcome recorded
Phase 1/2 NCT04574583 Nov 2020 → Feb 2023 metastatic malignant neoplasm National Cancer Institute (NCI) Completed No outcome recorded
Phase 1/2 NCT04432597 Aug 2020 → Nov 2022 overdue anal carcinoma, cervical cancer, oropharynx cancer, virus associated tumor National Cancer Institute (NCI) Active not recruiting No outcome recorded
Phase 1/2 NCT04303117 Jul 2020 → Dec 2028 expected Kaposi's sarcoma National Cancer Institute (NCI) Recruiting No outcome recorded
Phase 1/2 NCT04287868 Jun 2020 → Jul 2022 anal carcinoma, cervical cancer, oropharyngeal carcinoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 1/2 NCT04247282 Jun 2020 → Aug 2021 head and neck cancer National Cancer Institute (NCI) Completed No outcome recorded
Phase 221 trials
Phase 2 NCT05445882 Apr 2024 castration-resistant prostate carcinoma National Cancer Institute (NCI) Withdrawn No outcome recorded
Phase 2 NCT05012098 Jun 2022 → Jul 2024 esthesioneuroblastoma, nasal cavity neoplasm, olfactory neuroblastoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 2 NCT04874311 Mar 2022 → Jan 2027 expected soft tissue sarcoma Institut Bergonié Recruiting No outcome recorded
Phase 2 NCT05005429 Sep 2021 → Feb 2024 malignant pleural mesothelioma Fundación GECP Completed No outcome recorded
Phase 2 NCT04727541 Jul → Oct 2021 cholangiocarcinoma AIO-Studien-gGmbH Terminated No outcome recorded
Phase 2 NCT04971187 Jun 2021 → Feb 2022 non-small cell lung carcinoma M.D. Anderson Cancer Center Terminated No outcome recorded
Phase 2 NCT04878250 Jun 2021 → Jul 2023 transitional cell carcinoma, urinary bladder cancer Queen Mary University of London Unknown No outcome recorded
Phase 2 NCT04428047 Feb → Sep 2021 head and neck squamous cell carcinoma UNICANCER Terminated No outcome recorded
Phase 2 NCT04417660 Dec 2020 → Jul 2026 overdue thymoma, thymus cancer National Cancer Institute (NCI) Active not recruiting No outcome recorded
Phase 2 NCT04501094 Oct 2020 → Jan 2021 urothelial carcinoma National Cancer Institute (NCI) Terminated No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT04066491 Sep 2019 → May 2021 cholangiocarcinoma, gallbladder cancer EMD Serono Research & Development Institute, Inc. Terminated No outcome recorded
Phase 32 trials
Phase 3 NCT05061823 Dec 2021 → Mar 2025 lung cancer EMD Serono Research & Development Institute, Inc. Completed No outcome recorded
Phase 3 NCT03631706 Oct 2018 → Jun 2021 non-small cell lung carcinoma EMD Serono Research & Development Institute, Inc. Completed No outcome recorded
Phase not applicable1 trial
NCT04481256 Nov 2020 → Sep 2025 overdue esophageal cancer, squamous cell carcinoma Academic Medical Center - University of Amsterdam Recruiting No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/2 NCT04633252 Background Feb 2021 → Dec 2026 expected prostate cancer National Cancer Institute (NCI) Recruiting No outcome recorded

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 59 sources stand behind the page.

FieldValueCited text
Known as bintrafusp alfa Bintrafusp alfa (M7824) is a novel first-in-class bifunctional fusion protein composed of a monoclonal antibody against PD-L1 fused to the extracellular domain of human...” NCT04235777
33

“The purpose of the study is to evaluate the efficacy and safety of bintrafusp alfa (M7824) compared with pembrolizumab in participants with advanced NSCLC with high PD-L1-tumor...” NCT03631706

Bintrafusp alfa (M7824) is a bifunctional fusion protein consisting of an anti-programmed death ligand 1 (PD-L1) antibody functioning as an immune checkpoint inhibitor and the...” NCT04327986

Bintrafusp alfa (BA) is a bifunctional fusion protein composed of the extracellular domain of the transforming growth factor-β (TGF-β) receptor II fused to a human...” PMID 36066618 Sep 2022

“An Open Label, Single-arm, Multi-center Phase 1b/2 Combination Study of M7824 (Bintrafusp Alfa) and Paclitaxel in Recurrent/Metastatic Gastric Cancer as a Second-line Treatment” NCT04835896

Bintrafusp alfa (M7824)” NCT04417660

NCT04457778

NCT04878250

NCT04501094

NCT04708067

NCT04246489

NCT05005429

NCT05012098

NCT04708470

NCT04481256

NCT04428047

NCT04560686

NCT04756505

NCT02723955

NCT03579472

NCT04489940

NCT04648826

NCT04349280

NCT04789668

NCT04396535

NCT04874311

NCT04971187

NCT03524170

NCT05061823

NCT04220775

NCT03620201

NCT05445882

NCT04727541

NCT04396886

Known as 8L9YQ2N6PA ChEMBL registry synonym — accepted as the source's own label CHEMBL4298024
Known as M7824 “In this study, the optimal dose of inhaled AZA will be established in patients with unresectable pulmonary metastases who are receiving the dual immune checkpoint...” NCT04648826
27

“A Phase II Study of N-803 Alone or in Combination With BN-Brachyury Vaccine or Bintrafusp Alfa (M7824) for Participants With Castration Resistant Prostate Cancer” NCT05445882

“A Study to Evaluate the Efficacy and Safety of Bintrafusp Alfa (M7824) Monotherapy in Metastatic or Locally Advanced Urothelial Cancer” NCT04349280

“a bifunctional fusion protein targeting PD-L1 and TGF beta (M7824 (MSB0011359C)” NCT04491955

“Bintrafusp alfa (M7824)” NCT04417660

“Bintrafusp alfa (M7824)” NCT04501094

NCT04303117

NCT04551950

NCT04066491

NCT03631706

NCT03707587

NCT04247282

NCT04633252

NCT04296942

NCT04297748

NCT03427411

NCT04287868

NCT04835896

NCT03554473

NCT04235777

NCT04432597

NCT03436563

NCT03840902

NCT04327986

NCT04574583

NCT03493945

NCT03451773

NCT03833661

Known as MSB0011359C “Bintrafusp alfa (M7824 or MSB0011359C) is a bifunctional protein composed of the extracellular domain of the Transforming Growth Factor Beta Receptor 2 (TGF-BetaRII) receptor...” NCT04574583
5

“1/ Arm 1-Gemcitabine + de-escalating dose of M7824 (MSB0011359C)” NCT03451773

NCT04491955

NCT02699515

NCT02517398

NCT03315871

Action Inhibit “monoclonal antibody blocking PD-L1” PMID 33840050 Apr 2021
Modality Protein / enzyme biologic “M7824 (MSB0011359C) is an innovative first-in-class bifunctional fusion protein” PMID 29298798 Jan 2018
Route Intravenous intravenous infusion of MSB0011359C once every 2 weeks” NCT02517398
Target CD274 “Programmed cell death 1 ligand 1 binding agent” CHEMBL4298024