University College London | Centre for Clinical Microbiology
Status and phase
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Study type
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About
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.
Full 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.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
SCREENING PHASE
Inclusion Criteria:
Exclusion Criteria:
RANDOMISED TRIAL
Inclusion Criteria:
Exclusion Criteria:
ADDITIONAL EXCLUSION CRITERIA FOR SPECIFIC MTTs:
Patients assigned to receive oral therapies:
Futibatinib:
History and/or current evidence of any of the following disorders:
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:
Zanidatamab:
Neratinib & trastuzumab:
Encorafenib & binimetinib:
Primary purpose
Allocation
Interventional model
Masking
800 participants in 2 patient groups
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Central trial contact
Marta Jimenez
Data sourced from clinicaltrials.gov
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