Neoadjuvant Bintrafusp Alfa in Patients With Resectable Biliary Tract Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Biliary Tract Cancer
- Cholangiocarcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The only curative therapy for biliary tract cancer (BTC) is resection. However, recurrence rates are very high with a median recurrence-free survival (RFS) time of 18 months with adjuvant chemotherapy. Bintrafusp alfa is a bifunctional fusion protein targeting TGF-? and PD-L1 that has shown promisin...
The only curative therapy for biliary tract cancer (BTC) is resection. However, recurrence rates are very high with a median recurrence-free survival (RFS) time of 18 months with adjuvant chemotherapy. Bintrafusp alfa is a bifunctional fusion protein targeting TGF-? and PD-L1 that has shown promising activity in a second-line phase I BTC study. The neoadjuvant treatment approach is not a current standard in biliary tract cancer, but it is an accepted and frequently applied treatment strategy in other resectable and borderline-resectable cancers such as lung, gastric and rectal cancer. The hypothesis is that Bintrafusp alfa leads to a major pathological response in 30% of resectable BTC patients.
Tracking Information
- NCT #
- NCT04727541
- Collaborators
- Merck Serono GmbH, Germany
- Investigators
- Principal Investigator: Oliver Waidmann, Prof.Dr. Universitätsklinikum Frankfurt
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