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Page last updated: 10/26/2020

A phase 1b, single-arm study evaluating bintrafusp alfa for the treatment of patients with unresectable locally advanced or metastatic urothelial cancer that progressed or recurred after platinum-containing chemotherapy.*




ClinicalTrials.gov: NCT04349280


Locations: Europe and the United States


Now Enrolling

Key inclusion criteria

  • Participants must have histologically confirmed locally advanced or metastatic urothelial cancer that is unresectable and an ECOG PS of 0 or 1. Participants must have experienced disease progression or recurrence following platinum-containing chemotherapy* for urothelial cancer

Key exclusion criteria

  • Participants must not have received >2 lines of systemic therapy for metastatic disease or prior therapy targeting T-cell costimulation, checkpoint pathways, or TGF-β. Participants must not have pneumonitis or history of noninfectious pneumonitis that required systemic immunosuppressive treatment
Study design | Europe and the United States

ClinicalTrials.gov. A study to evaluate the efficacy and safety of bintrafusp alfa (M7824) monotherapy in metastatic or locally advanced urothelial cancer. https://clinicaltrials.gov/ct2/show/NCT04349280. Accessed October 26, 2020. GSK Identifier: 213152.



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Speak with a doctor before making a decision regarding whether a clinical trial is the right option.



Bintrafusp alfa is being investigated in this clinical trial. This means that it has not been shown to be safe or effective for any purpose or disease. This page describes one of the clinical trials for bintrafusp alfa, and it includes information about how the safety and efficacy of bintrafusp alfa will be measured and evaluated. Therefore, it is important to understand that bintrafusp alfa is not a treatment or therapy for cancer or any other disease, and it has not been approved to be used by any health authority, such as the European Medicines Agency or the US Food and Drug Administration, and there is no guarantee that bintrafusp alfa will be approved in the sought-after indication by any health authority worldwide.

Patients should speak with their doctors, who can help determine if a clinical trial might be the right option. Doctors will be able to answer patients' questions about the risk of participating in a trial, and what other options may be available to you.

*Participants must have experienced disease progression or recurrence either following platinum-containing chemotherapy given for unresectable locally advanced or metastatic urothelial cancer or within 12 months from completion of neoadjuvant or adjuvant platinum-containing chemotherapy for localized muscle-invasive urothelial cancer. 
†For a full list of inclusion and exclusion criteria, please visit www.clinicaltrials.gov
‡Up to 2 years or until progressive disease, death, unacceptable toxicity, or study withdrawal. 
DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; IV, intravenous; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; Q2W, every 2 weeks; TGF-β, transforming growth factor β. 


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