Neoadjuvant Bintrafusp Alfa in Patients With Resectable Biliary Tract Cancer (NEOBIL)
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|ClinicalTrials.gov Identifier: NCT04727541|
Recruitment Status : Terminated (Based on results of another phase II study with bintrafusp alfa in combination with gemcitabine plus cisplatin, that was discontinued as it was unlikely to meet the primary endpoint of OS, the recruitment for this study was stopped prematurely.)
First Posted : January 27, 2021
Last Update Posted : May 23, 2022
|Condition or disease||Intervention/treatment||Phase|
|Biliary Tract Cancer Cholangiocarcinoma||Drug: Bintrafusp alfa||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neoadjuvant Bintrafusp Alfa in Patients With Resectable Biliary Tract Cancer|
|Actual Study Start Date :||July 8, 2021|
|Actual Primary Completion Date :||October 4, 2021|
|Actual Study Completion Date :||January 5, 2022|
Experimental: Neoadjuvant therapy with Bintrafusp alfa
1200 mg of Bintrafusp alfa will be administered by intravenous infusion every 2 weeks for a total of 2 dosages (Q2W). Subsequently, the surgery will be performed.
Drug: Bintrafusp alfa
Neoadjuvant therapy with bintrafusp alfa
Other Name: MSB0011359C, M7824
- Major Pathologic Response (MPR) measured in the surgically resected tumor [ Time Frame: 24 months ]Response to neoadjuvant treatment will be determined according to the Becker score. MPR is defined by a Becker grade of 1 (1a or 1b), namely at least < 10% of viable tumor.
- Tumor Response [ Time Frame: 24 months ]Tumor Response according to RECIST1.1
- Rate of Resectability [ Time Frame: 24 months ]Rate of Resectability in biliary tract cancer patients
- Adverse events according to CTCAE V5 [ Time Frame: 24 months ]
- Adverse Events of Special Interest [ Time Frame: 24 months ]Postoperative wound infections, impaired wound healing, wound dehiscence, prolongation of post-op hospitalization beyond 14 days.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04727541
|Universitätsklinikum RWTH Aachen - Klinik für Allgemein-, Viszeral- und Transplantationschirurgie|
|Aachen, Germany, 52074|
|Universitätsklinikum Frankfurt - Medizinische Klinik 1|
|Frankfurt, Germany, 60590|
|Principal Investigator:||Oliver Waidmann, Prof.Dr.||Universitätsklinikum Frankfurt|