NCT05052099

Phase Ib/II Single-arm Study of mFOLFOX6, Bevacizumab and Atezolizumab in Advanced Biliary Tract Cancer

A Phase Ib/II Single-arm Study Evaluating the Safety and Efficacy of Combined Immunotherapy With mFOLFOX6, Bevacizumab and Atezolizumab in Advanced-stage Biliary Tract Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University Hospital, Essen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the study is to establish if patients with advanced bile duct cancer, who have already received a line of treatment for their disease, will receive any associated benefits from the combination of mFOLFOX6, bevacizumab and atezolizumab as a second-line therapy All patients who meet the criteria to participate in the study shall receive the following drugs intravenously every 14 days: mFOLFOX6 combined with Atezolizumab 840 mg and Bevacizumab 10 mg/kg. These drugs will be administered until one of the following situations arises: disease progress, intolerable side effects, pregnancy or if the patient or the doctor decide to stop the treatment. Atezolizumab is an antibody that operates on an important receptor of the immune system (PD1/PD-L1 axis). Atezolizumab (Tecentriq®) has already been approved in a number of countries to treat a range of tumours, although it has not yet been approved for bile duct tumours. Bevacizumab is an antibody that is joined to the vascular endothelial growth factor (VEGF). Bevacizumab was approved for the first time in the USA in 2004 and is now approved in over 100 countries around the world for a variety of conditions. However, it has not yet been approved for treating bile duct cancers. mFOLFOX6 is a chemotherapy regime used to treat many kinds of gastrointestinal tumours, including bile duct cancer, since it is a treatment approved for this type of tumour. The combination of mFOLFOX6 with atezolizumab and bevacizumab (trial drugs), may bring more information about an anti-tumour immune response that could improve the results of mFOLFOX6, which backs up the research on this treatment combination with cancer patients.

Conditions

• Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	mFOLFOX6, Atezolizumab and Bevacizumab	All study medication is administered by intravenous (IV) infusion on Day 1 of each 14-day cycle: • mFOLFOX6 consisting of Folinic acid (Leucovorin) 400 mg/m2 (D,L racemic form) or 200 mg/m2 (L-isomer form \[levo leucovorin\]), 5-fluorouracil (5-FU) 2400 mg/m2 and Oxaliplatin 85 mg/m2 combined with * Atezolizumab 840 mg and * Bevacizumab 10 mg/kg

Timeline

• Start date: 2021-10-22
• Primary completion: 2024-09-18
• Completion: 2024-09-18
• First posted: 2021-09-22
• Last updated: 2025-09-29

Locations

2 sites across 2 countries: Germany, Spain