The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Personalized Medicine for Advanced Biliary Cancer Patients
Official Title: Molecular Targeted Maintenance Therapy Versus Standard of Care in Advanced Biliary Cancer: an International, Randomised, Controlled, Open-label, Platform Phase 3 Trial
Study ID: NCT05615818
Brief 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.
Detailed Description: This is a Phase 3, multicentre, randomised, open-label trial to evaluate whether the introduction of molecular targeted therapy (MTT) as maintenance after 4 cycles of standard-of-care first-line systemic therapy (1L SoC) is superior to continuation of 1L-SoC in the treatment of patients with ABC. The trial is composed of two phases: (i) An initial screening phase to identify a suitable patient population, and (ii) a randomised comparative trial. The aim of the screening phase is to identify a medically suitable population, to obtain a molecular profile of the patient's tumour, to collect baseline data concerning patient demographics and disease characteristics and to obtain pre-treatment blood and tumour samples for further translational research. A genetic profile will be obtained from tumour-derived DNA and RNA samples by next-generation sequencing and from circulating tumour DNA. The trial Molecular Tumour Board will determine whether each patient harbours a targetable molecular alteration for one or more of the trial MTTs. Patients with disease control after 4 cycles of 1L-SoC, who did not experience limiting toxicity, and whose tumour harbours at least one targetable molecular alteration, will be invited to participate in the randomised phase of the trial in which 159 eligible patients will be randomised (2:1) to receive either maintenance therapy with a matched MTT or to continue 1L-SoC treatment.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Cliniques universitaires Saint-Luc, Brussels, , Belgium
CHU Amiens Picardie, Amiens, , France
CHU d'Angers, Angers, , France
Institut du Cancer Avignon Provence, Avignon, , France
CHU de Besançon, Besançon, , France
CHU de Bordeaux - Hôpital Haut-Leveque, Bordeaux, , France
Centre François Baclesse, Caen, , France
Centre Jean Perrin, Clermont-Ferrand, , France
CHU Estaing de Clermont Ferrand, Clermont-Ferrand, , France
APHP - Hopital Henri Mondor, Créteil, , France
CHU de Dijon, Dijon, , France
CHU Grenoble Alpes, Grenoble, , France
Centre Oscar Lambret, Lille, , France
CHU Lille, Lille, , France
CHU Dupuytren, Limoges, , France
Centre Leon Bérard, Lyon, , France
CHU de Lyon, Lyon, , France
Clinique Privée Jean Mermoz, Lyon, , France
APHM - CHU La Timone, Marseille, , France
Institut Paoli Calmettes, Marseille, , France
CHU Montpellier, Montpellier, , France
Institut de Cancer de Montpellier, Montpellier, , France
CHU Nantes - Hôtel Dieu, Nantes, , France
Centre Antoine Lacassagne, Nice, , France
APHP - Hôpital Beaujon, Paris, , France
APHP - Hôpital Cochin, Paris, , France
APHP - Hôpital Saint Antoine, Paris, , France
Groupe Hospitalier Diaconesses Croix Saint-Simon, Paris, , France
Institute Mutualiste Montsouris, Paris, , France
Hôpital Privé des Côtes d'Armor, Plérin, , France
CHU Poitiers, Poitiers, , France
CHU de Reims, Reims, , France
Institut Jean Godinot, Reims, , France
Centre Eugène Marquis, Rennes, , France
CHU Charles Nicolle, Rouen, , France
Institut de Cancerologie de l'Ouest, Saint-Herblain, , France
Hôpital Foch, Suresnes, , France
CHU Toulouse, Toulouse, , France
CHRU de Nancy, Vandœuvre-lès-Nancy, , France
APHP - Hôpital Paul Brousse, Villejuif, , France
Gustave Roussy, Villejuif, , France
Queen Elizabeth Hospital, Birmingham, , United Kingdom
Bristol, Bristol, , United Kingdom
Addenbrooke's Hospital, Cambridge, , United Kingdom
Castle Hill Hospital, Cottingham, , United Kingdom
St James's Hospital, Leeds, , United Kingdom
Clatterbridge Centre for Oncology, Liverpool, , United Kingdom
Guy's & St Thomas' Hospital, London, , United Kingdom
Hammersmith Hospital, London, , United Kingdom
Royal Marsden Hospital, London, , United Kingdom
University College London, London, , United Kingdom
Maidstone Hospital, Maidstone, , United Kingdom
The Christie Hospital, Manchester, , United Kingdom
Nottingham University Hospital, Nottingham, , United Kingdom
Oxford, Oxford, , United Kingdom
Sheffield, Sheffield, , United Kingdom
Southampton General Hospital, Southampton, , United Kingdom
Name: Malka David, MD
Affiliation: Institut Mutualiste Montsouris
Role: PRINCIPAL_INVESTIGATOR
Name: Julien Edeline, MD
Affiliation: Centre Eugène Marquis
Role: PRINCIPAL_INVESTIGATOR
Name: Ivan Borbath, MD
Affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Role: PRINCIPAL_INVESTIGATOR
Name: John Bridgewater, MD
Affiliation: University College London Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Juan W Valle
Affiliation: University of Manchester and The Christie NHS Foundation Trust
Role: PRINCIPAL_INVESTIGATOR