Personalized Medicine for Advanced Biliary Cancer Patients

PHASE3RecruitingINTERVENTIONAL
Enrollment

800

Participants

Timeline

Start Date

July 18, 2024

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2028

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)

Trial Locations (69)

Unknown

NOT_YET_RECRUITING

Cliniques universitaires de Bruxelles - Hôpital Erasme ULB, Brussels

NOT_YET_RECRUITING

Cliniques universitaires Saint-Luc, Brussels

NOT_YET_RECRUITING

Universitair Ziekenhuis Antwerpen (UZA), Edegem

NOT_YET_RECRUITING

Universitair Ziekenhuis Leuven, Leuven

RECRUITING

CHU Amiens Picardie, Amiens

RECRUITING

CHU d'Angers, Angers

RECRUITING

Institut de cancerologie de l'Ouest - Angers, Angers

RECRUITING

Institut du Cancer Avignon Provence, Avignon

RECRUITING

CHU de Besançon, Besançon

NOT_YET_RECRUITING

CHU de Bordeaux - Hôpital Haut-Leveque, Bordeaux

RECRUITING

Centre François Baclesse, Caen

RECRUITING

Centre Jean Perrin, Clermont-Ferrand

RECRUITING

CHU Estaing de Clermont Ferrand, Clermont-Ferrand

RECRUITING

APHP - Hopital Henri Mondor, Créteil

RECRUITING

CHU de Dijon, Dijon

NOT_YET_RECRUITING

CHU Grenoble Alpes, Grenoble

RECRUITING

Groupe hospitalier mutaliste de Grenoble - Institut Daniel Hollard, Grenoble

RECRUITING

Centre Oscar Lambret, Lille

RECRUITING

CHU Lille, Lille

RECRUITING

CHU Dupuytren, Limoges

NOT_YET_RECRUITING

Centre Leon Bérard, Lyon

NOT_YET_RECRUITING

Clinique Privée Jean Mermoz, Lyon

RECRUITING

Hospices Civils de Lyon - Croix Rousse, Lyon

NOT_YET_RECRUITING

APHM - CHU La Timone, Marseille

RECRUITING

Hôpital Européen, Marseille

RECRUITING

Institut Paoli Calmettes, Marseille

RECRUITING

Institut de Cancer de Montpellier, Montpellier

NOT_YET_RECRUITING

CHU Nantes - Hôtel Dieu, Nantes

RECRUITING

Centre Antoine Lacassagne, Nice

RECRUITING

APHP - Hôpital Beaujon, Paris

RECRUITING

APHP - Hôpital Cochin, Paris

RECRUITING

APHP - Hôpital Saint Antoine, Paris

NOT_YET_RECRUITING

Groupe Hospitalier Diaconesses Croix Saint-Simon, Paris

RECRUITING

Institute Mutualiste Montsouris, Paris

RECRUITING

CH de Pau, Pau

RECRUITING

CHU Poitiers, Poitiers

RECRUITING

CH Cornouaille, Quimper

RECRUITING

CHU de Reims, Reims

RECRUITING

Institut Jean Godinot, Reims

RECRUITING

Centre Eugène Marquis, Rennes

NOT_YET_RECRUITING

CHU Charles Nicolle, Rouen

NOT_YET_RECRUITING

Institut Curie - Saint Cloud, Saint-Cloud

NOT_YET_RECRUITING

Institut de Cancerologie de l'Ouest, Saint-Herblain

RECRUITING

Hôpital Foch, Suresnes

RECRUITING

CHU Toulouse, Toulouse

RECRUITING

CH Valence, Valence

RECRUITING

CHRU de Nancy, Vandœuvre-lès-Nancy

NOT_YET_RECRUITING

APHP - Hôpital Paul Brousse, Villejuif

RECRUITING

Gustave Roussy, Villejuif

RECRUITING

Queen Elizabeth Hospital, Birmingham

RECRUITING

Bristol Haematology and Oncology Centre, Bristol

NOT_YET_RECRUITING

Addenbrooke's Hospital, Cambridge

NOT_YET_RECRUITING

Castle Hill Hospital, Cottingham

NOT_YET_RECRUITING

St James's Hospital, Leeds

NOT_YET_RECRUITING

Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool

NOT_YET_RECRUITING

Guy's & St Thomas' Hospital, London

RECRUITING

Hammersmith Hospital, London

NOT_YET_RECRUITING

Royal Free Hospital, London

RECRUITING

Royal Marsden Hospital, London

RECRUITING

University College London, London

NOT_YET_RECRUITING

Maidstone Hospital, Maidstone

NOT_YET_RECRUITING

The Christie Hospital, Manchester

RECRUITING

Mount Vernon Cancer Centre, Northwood

RECRUITING

Nottingham University Hospital, Nottingham

NOT_YET_RECRUITING

Churchill Hospital, Oxford

NOT_YET_RECRUITING

North West Anglia NHS Foundation Trust, Peterborough

NOT_YET_RECRUITING

Weston Park Cancer Centre, Sheffield

NOT_YET_RECRUITING

Southampton General Hospital, Southampton

NOT_YET_RECRUITING

Singleton Hospital, Swansea

All Listed Sponsors
collaborator

Cancer Research UK & UCL Cancer Trials Centre

OTHER

collaborator

Belgian Group of Digestive Oncology

OTHER

collaborator

National Cancer Institute, France

OTHER_GOV

collaborator

Cancer Research UK

OTHER

collaborator

Taiho Oncology, Inc.

INDUSTRY

collaborator

Servier

INDUSTRY

collaborator

Zymeworks BC Inc.

INDUSTRY

collaborator

Accord Healthcare, Inc.

INDUSTRY

collaborator

Pierre Fabre Medicament

INDUSTRY

lead

UNICANCER

OTHER