NCT04727541

Neoadjuvant Bintrafusp Alfa in Patients With Resectable Biliary Tract Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: AIO-Studien-gGmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The NEOBIL study aims to investigate the feasibility, safety and efficacy of neoadjuvant Bintrafusp alfa in patients with resectable biliary tract cancer.

Detailed 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-β 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.

Conditions

• Biliary Tract Cancer
• Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Bintrafusp alfa	Neoadjuvant therapy with bintrafusp alfa

Timeline

• Start date: 2021-07-08
• Primary completion: 2021-10-04
• Completion: 2022-01-05
• First posted: 2021-01-27
• Last updated: 2022-05-23

Locations

2 sites across 1 country: Germany