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

NCT05052099 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-29

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University Hospital, Essen

    lead OTHER

Principal Investigators

  • Jens Siveke, Prof. Dr. · Universitätsklinikum Essen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-22
Primary Completion
2024-09-18
Completion
2024-09-18

Countries

  • Germany
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05052099 on ClinicalTrials.gov