Personalized Medicine for Advanced Biliary Cancer Patients

Summary

The object of this trial is to evaluate whether the introduction of a targeted therapy after 4 cycles of the current standard-of-care treatment for advanced biliary cancer is superior to continuing with the standard treatment.

The trial is composed of two phases: (i) An initial screening phase to identify a suitable patient population, during which a molecular profile of the patient's tumour will be obtained, and (ii) a randomised comparative trial in which patients with disease control after 4 cycles of standard treatment, and whose tumour harbours a targetable molecular alteration, will be randomised (2:1) to receive either a matched targeted therapy or to continue with the standard treatment.

Conditions

• Biliary Tract Neoplasms

Interventions

DRUG

Futibatinib

Dose 20 mg once a day (QD)

DRUG

Ivosidenib

Dose 500 mg QD

DRUG

Zanidatamab

Dose: Patients \< 70 kg: 1800 mg every 3 weeks (Q3W), Patients ≥ 70 kg: 2400 mg Q3W

DRUG

Trastuzumab

Loading dose 8 mg/kg, then 6 mg/kg Q3W (Combination with neratinib)

DRUG

Neratinib

Dose: 240 mg QD (combination with trastuzumab)

DRUG

Encorafenib

Dose: 450 mg QD (Combination with binimetinib)

DRUG

Binimetinib

Dose: 45 mg twice a day (BID) (Combination with encorafenib)

DRUG

Niraparib

Dose: 200 mg QD or 300 mg QD

DRUG

Cisplatin

Dose: 25 mg/m2 IV on days 1 and 8 Q3W (CISGEM)

DRUG

Gemcitabine

Dose: 1000 mg/m2 IV on days 1 and 8 Q3W (CISGEM)

Sponsors & Collaborators

• Cancer Research UK & UCL Cancer Trials Centre

  collaborator OTHER

• Belgian Group of Digestive Oncology

  collaborator OTHER

• National Cancer Institute, France

  collaborator OTHER_GOV

• Cancer Research UK

  collaborator OTHER

• Taiho Oncology, Inc.

  collaborator INDUSTRY

• Servier

  collaborator INDUSTRY

• Zymeworks BC Inc.

  collaborator INDUSTRY

• Accord Healthcare, Inc.

  collaborator INDUSTRY

• Pierre Fabre Medicament

  collaborator INDUSTRY

• UNICANCER

  lead OTHER

Principal Investigators

• Malka David, MD · Institut Mutualiste Montsouris

• 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

• Juan W Valle · University of Manchester and The Christie NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-18

Primary Completion

2027-06-30

Completion

2028-06-30

Countries

• Belgium
• France
• United Kingdom

Study Locations