Personalized Medicine for Advanced Biliary Cancer Patients
SAFIR-ABC10
Molecular Targeted Maintenance Therapy Versus Standard of Care in Advanced Biliary Cancer: an International, Randomised, Controlled, Open-label, Platform Phase 3 Trial
3 other identifiers
interventional
800
3 countries
69
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2024
Typical duration for phase_3
69 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2022
CompletedFirst Posted
Study publicly available on registry
November 14, 2022
CompletedStudy Start
First participant enrolled
July 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
April 23, 2025
November 1, 2024
2.9 years
October 28, 2022
April 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS)
Time from randomisation to the first documented progression of disease (PD) as assessed by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first.
From randomisation to disease progression or death, up to 5 years.
Secondary Outcomes (7)
Overall Survival (OS)
From randomisation to death, up to 5 years.
Objective response rate
From randomisation, up to 5 years.
Time to treatment failure
From randomisation to treatment failure event, up to 5 years.
Progression-free survival after next line of treatment (PFS2)
From randomisation to second disease progression or death, up to 5 years.
Duration of response
From response to disease progression or death, up to 5 years.
- +2 more secondary outcomes
Other Outcomes (5)
Feasibility of molecular screening
Up to 3 months from start of treatment
Quality of life questionnaire - Core 30 (QLQ-C30)
From baseline, every 3 cycles (every 9 weeks) until end of treatment, an average of 1 year
Quality of life Questionnaire - Biliary tract cancer module (QLQ-BIL21)
From baseline, every 3 cycles (every 9 weeks) until end of treatment, an average of 1 year
- +2 more other outcomes
Study Arms (2)
Experimental
EXPERIMENTALMolecular targeted therapy matched to genetic alteration carried by the tumour
Control
ACTIVE COMPARATORContinued standard of care treatment for first-line biliary tract cancer
Interventions
Dose: Patients \< 70 kg: 1800 mg every 3 weeks (Q3W), Patients ≥ 70 kg: 2400 mg Q3W
Loading dose 8 mg/kg, then 6 mg/kg Q3W (Combination with neratinib)
Dose: 45 mg twice a day (BID) (Combination with encorafenib)
Eligibility Criteria
You may qualify if:
- Signed a written informed consent form prior to any trial specific procedures (Consent #1)
- Histologically-proven intrahepatic, perihilar or distal cholangiocarcinoma, or gallbladder carcinoma (ampullary carcinoma excluded)
- De novo or recurrent, locally advanced (non-resectable) or metastatic disease
- Availability of a suitable archived sample of primary or metastatic tumour tissue (frozen, or FFPE) or able to undergo a biopsy to obtain a suitable malignant tissue sample
- Aged ≥18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Estimated life expectancy \>3 months
- Candidate for 1L-SoC therapy, or has initiated first cycle of 1L-SoC therapy
- Affiliated to a social security system or in possession of equivalent private health insurance (according to local country health provision arrangements).
You may not qualify if:
- Contraindication to 1L-SoC
- Patients who are candidates for locoregional therapy
- Contraindication to tumour biopsy in the absence of suitable archived sample of tumour tissue
- Prior anticancer therapy in the palliative setting. Adjuvant capecitabine allowed if completed ≥ 183 days prior to study entry
- Received more than 1 cycle of treatment with 1L-SoC
- Prior treatment with any of the MTT under investigation in the SAFIR-ABC10 study
- Current malignancies (other than ABC), with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for 5 years or more and are deemed at negligible risk for recurrence, are eligible for the trial
- Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol
- Women who are pregnant or breast-feeding
- Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons
- Individuals deprived of liberty or placed under protective custody or guardianship
- RANDOMISED TRIAL
- Signed a written informed consent form prior to any trial specific procedures (Consent #2)
- Molecular profile showing the tumour harbours at least one targetable molecular alteration with a MTT in the study portfolio (as determined by the trial MTB)
- Disease control (stable or responsive) after 4 cycles of 1L-SoC, compared to a pre-treatment disease evaluation, as assessed by the investigator
- +66 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UNICANCERlead
- Cancer Research UK & UCL Cancer Trials Centrecollaborator
- Belgian Group of Digestive Oncologycollaborator
- National Cancer Institute, Francecollaborator
- Cancer Research UKcollaborator
- Taiho Oncology, Inc.collaborator
- Serviercollaborator
- Zymeworks BC Inc.collaborator
- Accord Healthcare, Inc.collaborator
- Pierre Fabre Medicamentcollaborator
Study Sites (69)
Cliniques universitaires de Bruxelles - Hôpital Erasme ULB
Brussels, Belgium
Cliniques universitaires Saint-Luc
Brussels, Belgium
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, Belgium
Universitair Ziekenhuis Leuven
Leuven, Belgium
CHU Amiens Picardie
Amiens, France
CHU d'Angers
Angers, France
Institut de cancerologie de l'Ouest - 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
Groupe hospitalier mutaliste de Grenoble - Institut Daniel Hollard
Grenoble, France
Centre Oscar Lambret
Lille, France
CHU Lille
Lille, France
CHU Dupuytren
Limoges, France
Centre Leon Bérard
Lyon, France
Clinique Privée Jean Mermoz
Lyon, France
Hospices Civils de Lyon - Croix Rousse
Lyon, France
APHM - CHU La Timone
Marseille, France
Hôpital Européen
Marseille, France
Institut Paoli Calmettes
Marseille, 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
CH de Pau
Pau, France
CHU Poitiers
Poitiers, France
CH Cornouaille
Quimper, France
CHU de Reims
Reims, France
Institut Jean Godinot
Reims, France
Centre Eugène Marquis
Rennes, France
CHU Charles Nicolle
Rouen, France
Institut Curie - Saint Cloud
Saint-Cloud, France
Institut de Cancerologie de l'Ouest
Saint-Herblain, France
Hôpital Foch
Suresnes, France
CHU Toulouse
Toulouse, France
CH Valence
Valence, 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 Haematology and Oncology Centre
Bristol, United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom
Castle Hill Hospital
Cottingham, United Kingdom
St James's Hospital
Leeds, United Kingdom
Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom
Guy's & St Thomas' Hospital
London, United Kingdom
Hammersmith Hospital
London, United Kingdom
Royal Free 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
Mount Vernon Cancer Centre
Northwood, United Kingdom
Nottingham University Hospital
Nottingham, United Kingdom
Churchill Hospital
Oxford, United Kingdom
North West Anglia NHS Foundation Trust
Peterborough, United Kingdom
Weston Park Cancer Centre
Sheffield, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
Singleton Hospital
Swansea, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Malka David, MD
Institut Mutualiste Montsouris
- PRINCIPAL INVESTIGATOR
Julien Edeline, MD
Centre Eugène Marquis
- PRINCIPAL INVESTIGATOR
Ivan Borbath, MD
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- PRINCIPAL INVESTIGATOR
John Bridgewater, MD
University College London Cancer Institute
- PRINCIPAL INVESTIGATOR
Juan W Valle
University of Manchester and The Christie NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2022
First Posted
November 14, 2022
Study Start
July 18, 2024
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2028
Last Updated
April 23, 2025
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data.
- Access Criteria
- The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement.
Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.