AzTrials
AzTrials

Biliary Tract NeoplasmsPhase 3SAFIR-ABC10NCT05615818

Personalized Medicine for Advanced Biliary Cancer Patients

A Phase 3 study testing Futibatinib, Ivosidenib and Zanidatamab in people with Biliary Tract Neoplasms, run by UNICANCER at 69 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Biliary Tract Neoplasms
What is being tested?
Futibatinib, Ivosidenib and Zanidatamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
800 participants
Where
69 sitesin 3 countries
Study dates
18 Jul 2024to Jun 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 23Show fewer
  • 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).
  • 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
  • ECOG performance status of 0 or 1
  • Presence of at least one evaluable lesion according to RECIST v1.1, or complete response to 12 weeks 1L-SoC
  • Adequate bone marrow function: absolute neutrophil count (ANC) ≥1.5 × 10⁹/L, platelet count ≥100 × 10⁹/L, and haemoglobin ≥9 g/dL
  • Adequate liver function: total bilirubin level ≤1.5 × the upper limit of normal (ULN) range (total bilirubin ≤3.0 ULN when the patient has documented Gilbert syndrome), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤2.5 × ULN (AST and ALT ≤5 ULN when documented tumour liver involvement)
  • Adequate renal function: estimated creatinine clearance ≥ 60 mL/min according to the Cockcroft-Gault formula
  • Adequate cardiac function: left ventricular ejection fraction ≥50% at baseline as determined by either echocardiogram or multigated acquisition scan (MUGA)
  • Adequate biliary drainage, with no evidence of ongoing infection
  • Men, and women of childbearing potential (WOCBP) must agree to use adequate contraception for the duration of trial participation and as required after completing study treatment. Men must also agree to not donate sperm and women must agree to not donate oocytes during the specified period.
  • Women of childbearing potential must have a negative serum pregnancy test performed within 3 days before the date of randomisation
  • Willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests, and other study procedures
  • Affiliated to a social security system or in possession of equivalent private health insurance (according to local country health provision arrangements)

Who cannot join

  • 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
Show all 69Show fewer
  • 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
  • Disease progression occurring at any time prior randomisation, or toxicity that led to the discontinuation of the 1L-SoC before 4 full cycles have been delivered
  • Toxicities from 1L-SoC not resolved to Grade ≤ 1 (according to version 5.0 the National Cancer Institute - Common terminology criteria for adverse events [NCI-CTCAE v5.0]) before randomisation, with the exception of alopecia
  • Contraindication or known hypersensitivity to the MTT for the molecular alteration found in the patient, or any component in their formulation Note: For patients with multiple target alterations, contraindication to one MTT will not warrant exclusion if MTT to an alternative target is feasible.
  • Microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) cancers
  • Major surgery within 4 weeks of randomisation
  • Radiotherapy within 7 days of randomisation
  • Untreated central nervous system (CNS) metastases, symptomatic CNS metastases, or radiation treatment for CNS metastases within 4 weeks of start of study treatment. Stable, treated brain metastases are allowed (defined as subjects who are off steroids and anticonvulsants and are neurologically stable with no evidence of radiographic progression for at least 4 weeks at the time of screening).
  • Clinically significant cardiovascular disease (recent acute myocardial infarction, treated congestive heart failure [2 or above on the New York Heart Association functional classification scale], recent thromboembolic or cerebrovascular events [within 12 weeks, excepted if related to indwelling catheter], known prolonged QT syndrome).
  • Cardiorespiratory pathologies where hyperhydration is contraindicated.
  • Manifestation of tinnitus and/or hearing loss since initiation of cisplatin therapy.
  • Known leptomeningeal disease. If leptomeningeal disease has been reported radiographically on baseline magnetic responance imaging (MRI), but is not suspected clinically by the investigator, the subject must be free of neurological symptoms.
  • Concurrent malignancy (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
  • Concomitant treatment with phenytoin in prophylactic use where this cannot be substituted for another therapy
  • Known active hepatitis B virus or hepatitis C virus infection or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome
  • 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
  • Participation in another therapeutic trial within the 30 days prior to entering the study. Participation in an observational trial would be acceptable
  • 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
  • ADDITIONAL EXCLUSION CRITERIA FOR SPECIFIC MTTs:
  • Patients assigned to receive oral therapies:
  • Inability or unwillingness to swallow pills
  • History of malabsorption syndrome or other condition that would interfere with enteral absorption. For example, active intestine inflammation (e.g., Crohn's disease or ulcerative colitis) requiring immunosuppressive therapy
  • Futibatinib:
  • History and/or current evidence of any of the following disorders:
  • Non-tumour related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the Investigator
  • Ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, or myocardia and lung, considered clinically significant in the opinion of the Investigator
  • Retinal or corneal disorder confirmed by retinal/corneal examination and considered clinically significant in the opinion of the Investigator
  • Concomitant treatment with strong CYP3A/P-gp inhibitors or strong or moderate CYP3A/P gp inducers where these cannot be substituted for another therapy.
  • Ivosidenib:
  • Patients with history of torsade de pointes
  • Concomitant treatment with digoxin where this cannot be substituted for another therapy
  • Patients with a heart-rate corrected QT interval (using Fridericia's formula) (QTcF) ≥ 450 msec or other factors that increased the risk of QT prolongation or arrhythmic events (e.g. heart failure, hypokalemia, family history of long QT interval syndrome)
  • Concomitant treatment with strong CYP3A4 inducers or dabigatran where these cannot be substituted for another therapy
  • Concomitant treatment with medicinal products known to prolong the QTc interval, or moderate or strong CYP3A4 inhibitors where these cannot be substituted for another therapy
  • Familial history of sudden death or polymorphic ventricular arrhythmia.
  • Hypokalemia, hypomagnesemia or hypocalcemia where this cannot be corrected by supplementation
  • Zanidatamab:
  • Treatment with anthracyclines within 90 days before first dose of zanidatamab and/or total lifetime load exceeding 360 mg/m2 Adriamycin® or equivalent
  • Use of corticosteroids administered at doses equivalent to > 15 mg per day of prednisone within 2 weeks of first zanidatamab dosing unless otherwise approved by the coordinating investigator. Topical, ocular, intra-articular, intranasal, and/or inhalational corticosteroids are permitted
  • QTcF > 470 ms
  • History of myocardial infarction or unstable angina within 6 months prior to enrollment, troponin levels consistent with myocardial infarction, or clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension, or any history of symptomatic congestive heart failure
  • Acute or chronic uncontrolled pancreatitis or Child-Pugh Class C liver disease
  • Clinically significant infiltrative pulmonary disease not related to lung metastases
  • A history of life-threatening hypersensitivity to monoclonal antibodies or recombinant proteins
  • Neratinib \& trastuzumab:
  • Patients with severe hepatic impairment (Child-Pugh Class C)
  • Co-administration with the following medical products that are strong inducers of the CYP3A4/P-gp isoform of cytochrome P450, such as carbamazepine, phenytoin (antiepileptics), St John's wort (Hypericum perforatum) or rifampicin (antimycobacterial)
  • Patients who are experiencing dyspnoea at rest due to complications of advanced malignancy or co-morbidities
  • Hypersensitivity to murine proteins
  • Current active pneumonitis within 90 days of receiving trastuzumab or a known history of interstitial lung disease
  • Encorafenib \& binimetinib:
  • Patients with a history or current evidence of retinal vein occlusion or risk factors for retinal vein occlusion (e.g., uncontrolled glaucoma or history of hyperviscosity or hypercoagulability syndrome)
  • Patients with concurrent neuromuscular disorders associated with elevated creatine phosphokinase (>ULN)
  • Patients with hypokalemia, hypomagnesemia, or hypocalcemia (i.e. Serum potassium, magnesium or calcium < lower normal limit)
  • Patients with a QTcF ≥ 450 msec for men, or ≥ 470 msec for women
  • Current or expected use of a strong inhibitor of CYP3A4

Trial locations and contacts

69 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Marta Jimenez contact

+33 (0) 1 44 23 55 58

m-jimenez@unicancer.fr

69 sites in 3 countries

France45 sites, 45 recruiting

  • CHU Amiens Picardie

    Amiens

    Vincent HAUTEFEUILE, MD

    Vincent HAUTEFEUILE, MD

    Recruiting

  • CHU d'Angers

    Angers

    Carole Vitellius

    Carole Vitellius, MD

    Recruiting

  • Institut de cancerologie de l'Ouest - Angers

    Angers

    Victor SIMMET, MD

    Victor SIMMET, MD

    Recruiting

  • Institut du Cancer Avignon Provence

    Avignon

    Clémence TOULLEC

    Clémence TOULLEC, MD

    Recruiting

  • CHU de Besançon

    Besançon

    Christophe BORG

    Christophe BORG, MD

    Recruiting

  • CHU de Bordeaux - Hôpital Haut-Leveque

    Bordeaux

    Jean-Frédéric BLANC

    Jean-Frédéric BLANC, MD

    Not yet recruiting

  • Centre François Baclesse

    Caen

    Stéphane CORBINAIS

    Stéphane CORBINAIS, MD

    Recruiting

  • Centre Jean Perrin

    Clermont-Ferrand

    Florence OSAER-POLYCARPE

    Florence OSAER-POLYCARPE, MD

    Recruiting

  • CHU Estaing de Clermont Ferrand

    Clermont-Ferrand

    Marine JARY, MD

    Marine JARY, MD

    Recruiting

  • APHP - Hopital Henri Mondor

    Créteil

    Christophe TOURNIGAND, MD

    Christophe TOURNIGAND, MD

    Recruiting

  • CHU de Dijon

    Dijon

    Sylvain MANFREDI

    Sylvain MANFREDI, MD

    Recruiting

  • CHU Grenoble Alpes

    Grenoble

    Gael ROTH, MD

    Gael ROTH, MD

    Not yet recruiting

  • Groupe hospitalier mutaliste de Grenoble - Institut Daniel Hollard

    Grenoble

    Camille HERVE, MD

    Camille HERVE, MD

    Recruiting

  • Centre Oscar Lambret

    Lille

    Aurélien CARNOT, MD

    Aurélien CARNOT, MD

    Recruiting

  • CHU Lille

    Lille

    Anthony TURPIN, MD

    Anthony TURPIN, MD

    Recruiting

  • CHU Dupuytren

    Limoges

    Frédéric THUILLIER, MD

    Frédéric THUILLIER, MD

    Recruiting

  • Centre Leon Bérard

    Lyon

    Philippe CASSIER, MD

    Philippe CASSIER, MD

    Not yet recruiting

  • Clinique Privée Jean Mermoz

    Lyon

    Lea CLAVEL, MD

    Lea CLAVEL, MD

    Not yet recruiting

  • Hospices Civils de Lyon - Croix Rousse

    Lyon

    Marielle GUILLET, MD

    Marielle GUILLET, MD

    Recruiting

  • APHM - CHU La Timone

    Marseille

    Laétitia DAHAN, MD

    Laétitia DAHAN, MD

    Not yet recruiting

  • Hôpital Européen

    Marseille

    Nicolas BARRIERE, MD

    Nicolas BARRIERE, MD

    Recruiting

  • Institut Paoli Calmettes

    Marseille

    Simon LAUNAY, MD

    Simon LAUNAY, MD

    Recruiting

  • Institut de Cancer de Montpellier

    Montpellier

    Fabienne PORTALES, MD

    Fabienne PORTALES, MD

    Recruiting

  • CHU Nantes - Hôtel Dieu

    Nantes

    Yann TOUCHEFEU, MD

    Yann TOUCHEFEU, MD

    Not yet recruiting

  • Centre Antoine Lacassagne

    Nice

    Ludovic EVESQUE, MD

    Ludovic EVESQUE, MD

    Recruiting

  • APHP - Hôpital Beaujon

    Paris

    Mohamed BOUATTOUR, MD

    Mohamed BOUATTOUR, MD

    Recruiting

  • APHP - Hôpital Cochin

    Paris

    Romain CORIAT, MD

    Romain CORIAT, MD

    Recruiting

  • APHP - Hôpital Saint Antoine

    Paris

    Helene BOUSSION DESLOGES, MD

    Helene BOUSSION DESLOGES, MD

    Recruiting

  • Groupe Hospitalier Diaconesses Croix Saint-Simon

    Paris

    Olivier DUBREUIL, MD

    Olivier DUBREUIL, MD

    Not yet recruiting

  • Institute Mutualiste Montsouris

    Paris

    David MALKA, MD

    David MALKA, MD

    Recruiting

  • CH de Pau

    Pau

    Juliette THAURY, MD

    Juliette THAURY, MD

    Recruiting

  • CHU Poitiers

    Poitiers

    David TOUGERON, MD

    David TOUGERON, MD

    Recruiting

  • CH Cornouaille

    Quimper

    Christophe AGNELLO, MD

    Christophe AGNELLO, MD

    Recruiting

  • CHU de Reims

    Reims

    Elia GIGANTE, MD

    Elia GIGANTE, MD

    Recruiting

  • Institut Jean Godinot

    Reims

    Damien BOTSEN, MD

    Damien BOTSEN, MD

    Recruiting

  • Centre Eugène Marquis

    Rennes

    Julien Edeline

    Julien Edeline, MD

    Recruiting

  • CHU Charles Nicolle

    Rouen

    Frederic DI FIORE, MD

    Frederic DI FIORE, MD

    Not yet recruiting

  • Institut Curie - Saint Cloud

    Saint-Cloud

    Cindy NEUZILLET, MD

    Cindy NEUZILLET, MD

    Not yet recruiting

  • Institut de Cancerologie de l'Ouest

    Saint-Herblain

    Amélie MALLET, MD

    Amélie MALLET, MD

    Not yet recruiting

  • Hôpital Foch

    Suresnes

    Jaafar BENNOUNA, MD

    Jaafar BENNOUNA, MD

    Recruiting

  • CHU Toulouse

    Toulouse

    Nadim FARES, MD

    Nadim FARES, MD

    Recruiting

  • CH Valence

    Valence

    Hélène FOISY, MD

    Hélène FOISY, MD

    Recruiting

  • CHRU de Nancy

    Vandœuvre-lès-Nancy

    Marie MULLER, MD

    Marie MULLER, MD

    Recruiting

  • APHP - Hôpital Paul Brousse

    Villejuif

    Olivier ROSMORDUC, MD

    Olivier ROSMORDUC, MD

    Not yet recruiting

  • Gustave Roussy

    Villejuif

    Antoine Hollebecque

    Antoine Hollebecque, MD

    Recruiting

Other trials in France

United Kingdom20 sites, 20 recruiting

  • Queen Elizabeth Hospital

    Birmingham

    Yuk Ting MA, MD

    Yuk Ting MA, MD

    Recruiting

  • Bristol Haematology and Oncology Centre

    Bristol

    Stephen FALK, MD

    Stephen FALK, MD

    Recruiting

  • Addenbrooke's Hospital

    Cambridge

    Pippa CORRIE, MD

    Pippa CORRIE, MD

    Not yet recruiting

  • Castle Hill Hospital

    Cottingham

    Anthony MARAVEYAS, MD

    Anthony MARAVEYAS, MD

    Not yet recruiting

  • St James's Hospital

    Leeds

    Alan ANTHONEY, MD

    Alan ANTHONEY, MD

    Not yet recruiting

  • Clatterbridge Cancer Centre NHS Foundation Trust

    Liverpool

    Daniel PALMER, MD

    Daniel PALMER, MD

    Not yet recruiting

  • Guy's & St Thomas' Hospital

    London

    Paul ROSS, MD

    Paul ROSS, MD

    Not yet recruiting

  • Hammersmith Hospital

    London

    Harpreet WASAN, MD

    Harpreet WASAN, MD

    Recruiting

  • Royal Free Hospital

    London

    Roopinder GILLMORE, MD

    Roopinder GILLMORE, MD

    Not yet recruiting

  • Royal Marsden Hospital

    London

    Sheela RAO, MD

    Sheela RAO, MD

    Recruiting

  • University College London

    London

    John BRIDGEWATER, MD

    John BRIDGEWATER, MD

    Recruiting

  • Maidstone Hospital

    Maidstone

    Justin WATERS, MD

    Justin WATERS, MD

    Not yet recruiting

  • The Christie Hospital

    Manchester

    Mairead MCNAMARA, MD

    Mairead MCNAMARA, MD

    Not yet recruiting

  • Mount Vernon Cancer Centre

    Northwood

    Vasiliki MICHALAREA, MD

    Vasiliki MICHALAREA, MD

    Recruiting

  • Nottingham University Hospital

    Nottingham

    Aurora ARVIND, MD

    Aurora ARVIND, MD

    Recruiting

  • Churchill Hospital

    Oxford

    Paul MILLER, MD

    Paul MILLER, MD

    Not yet recruiting

  • North West Anglia NHS Foundation Trust

    Peterborough

    Ankit RAO, MD

    Ankit RAO, MD

    Not yet recruiting

  • Weston Park Cancer Centre

    Sheffield

    Ahmad SABBAGH, MD

    Ahmad SABBAGH, MD

    Not yet recruiting

  • Southampton General Hospital

    Southampton

    Tim IVESON, MD

    Tim IVESON, MD

    Not yet recruiting

  • Singleton Hospital

    Swansea

    Steve KIHARA, MD

    Steve KIHARA, MD

    Not yet recruiting

Other trials in United Kingdom

Belgium4 sites, 4 recruiting

  • Cliniques universitaires de Bruxelles - Hôpital Erasme ULB

    Brussels

    Anne DEMOLS, MD

    Anne DEMOLS, MD

    Not yet recruiting

  • Cliniques universitaires Saint-Luc

    Brussels

    Ivan BORBATH, MD

    Ivan BORBATH, MD

    Not yet recruiting

  • Universitair Ziekenhuis Antwerpen (UZA)

    Edegem

    Timon VANDAMME, MD

    Timon VANDAMME, MD

    Not yet recruiting

  • Universitair Ziekenhuis Leuven

    Leuven

    Jeroen DEKERVEL, MD

    Jeroen DEKERVEL, MD

    Not yet recruiting

Other trials in Belgium

About this study

Official title: Molecular Targeted Maintenance Therapy Versus Standard of Care in Advanced Biliary Cancer: an International, Randomised, Controlled, Open-label, Platform Phase 3 Trial

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.

Read the 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.

Being tested
Futibatinib, Ivosidenib, Zanidatamab, Trastuzumab, Neratinib
Keywords
Biliary Tract Neoplasms, Targeted therapy, Personalised medicine
Medical subject headings
Biliary Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FutibatinibDrug

    Dose 20 mg once a day (QD)

  • IvosidenibDrug

    Also called Tibsovo

    Dose 500 mg QD

  • ZanidatamabDrug

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

  • TrastuzumabDrug

    Also called Zercepac

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

  • NeratinibDrug

    Also called Nerlynx

    Dose: 240 mg QD (combination with trastuzumab)

  • EncorafenibDrug

    Also called Braftovi

    Dose: 450 mg QD (Combination with binimetinib)

  • BinimetinibDrug

    Also called Mektovi

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

  • NiraparibDrug

    Also called Zejula

    Dose: 200 mg QD or 300 mg QD

  • CisplatinDrug

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

  • GemcitabineDrug

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

Study groups in NCT05615818
Study groupRoleWhat they receive
ExperimentalExperimentalMolecular targeted therapy matched to genetic alteration carried by the tumour
Receives: Drug: Futibatinib; Drug: Ivosidenib; Drug: Zanidatamab; Drug: Trastuzumab; Drug: Neratinib; Drug: Encorafenib; Drug: Binimetinib; Drug: Niraparib
ControlActive comparatorContinued standard of care treatment for first-line biliary tract cancer
Receives: Drug: Cisplatin; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From randomisation to disease progression or death, up to 5 years.

Secondary outcomes (7)

  1. Overall Survival (OS)

    The overall survival is the length of time from randomization that patients enrolled in the study are still alive.

    Measured: From randomisation to death, up to 5 years.

  2. Objective response rate

    Objective response rate is defined as the proportion of patients achieving complete response (CR) or partial response (PR) (according to RECIST v1.1). Objective response rate will be presented as the best response achieved compared to the disease assessment performed at randomisation.

    Measured: From randomisation, up to 5 years.

  3. Time to treatment failure

    Time from patient starting their allocated treatment to the date at which a patient first experiences a treatment failure event. The following will be considered as treatment failure events: early treatment discontinuation (regardless of reason), disease progression, death, starting a new treatment after completing scheduled treatment, withdrawal from the study due to any reason or loss to follow-up.

    Measured: From randomisation to treatment failure event, up to 5 years.

  4. Progression-free survival after next line of treatment (PFS2)

    Time from randomisation to the date of second disease progression or death, whichever occurs first.

    Measured: From randomisation to second disease progression or death, up to 5 years.

  5. Duration of response

    Duration of response is defined as the time from first documented response (compared to baseline measurement taken at randomisation) until the date of disease progression, as assessed by the investigator according to RECIST v1.1, or death from any cause whichever occurs first.

    Measured: From response to disease progression or death, up to 5 years.

  6. Disease control rate

    Disease control rate is defined as the proportion of randomised patients achieving CR, PR, stable disease (SD)/no evidence of disease (NED) as assessed by the investigator according to RECIST v1.1.

    Measured: From randomisation, up to 5 years.

  7. Percentage change in tumour size

    Taking the measurements at randomisation as the reference.

    Measured: From randomisation, up to 5 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2022
  2. Study start18 Jul 2024
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05615818
Sponsor's protocol ID
UC-GMP-2201 - PRODIGE 78
Other IDs
2022-000190-19, 2022-502403-30-00
Acronym
SAFIR-ABC10
Status last verified
Apr 2026
First submitted
28 Oct 2022
Last updated
19 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Futibatinib, Ivosidenib and Zanidatamab in people with Biliary Tract Neoplasms, run by UNICANCER at 69 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 69 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in France, United Kingdom, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marta Jimenez (+33 (0) 1 44 23 55 58, m-jimenez@unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: From randomisation to disease progression or death, up to 5 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05615818.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.

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