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Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients

NCT06529718 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-05-19

No results posted yet for this study

Summary

The object of this trial is to test whether ivonescimab is superior to standard chemotherapy (FOLFOX regimen) for the treatment of patients with advanced biliary tract cancer after failure of a first line of chemotherapy. It is only open to patients who participated in the SAFIR-ABC10 trial (NCT05615818) but did not receive experimental treatment.

Eligible patients will be randomised (2:1) to receive either ivonescimab or FOLFOX. Treatment will be continued until disease progression, or a maximum of 34 cycles of ivonescimab (experimental arm), whichever occurs first.

Conditions

  • Biliary Tract Cancer

Interventions

DRUG

Ivonescimab

20 mg/kg IV infusion every 3 weeks

DRUG

FOLFOX regimen

oxaliplatin 85 mg/m² IV, leucovorin 200 mg/m² IV (or folinic acid 400 mg/m²), and fluorouracil (5-FU) 400 mg/m² IV bolus; followed by 5 FU 2400 mg/m² as a 46 hour continuous IV infusion, every 2 weeks

Sponsors & Collaborators

  • Cancer Research UK & UCL Cancer Trials Centre

    collaborator OTHER

  • Belgian Group of Digestive Oncology

    collaborator OTHER

  • Summit Therapeutics

    collaborator INDUSTRY

  • UNICANCER

    lead OTHER

Principal Investigators

  • Julien Edeline, MD · Centre Eugène Marquis

  • Ivan Borbath, MD · Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  • John Bridgewater, MD · University College London Cancer Institute

  • David Malka, MD · Institut Mutualiste Montsouris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-09
Primary Completion
2027-08-03
Completion
2029-01-30

Countries

  • France
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT06529718 on ClinicalTrials.gov