drugset / Trial / NCT05615818
Personalized Medicine for Advanced Biliary Cancer Patients
Phase 3
Recruiting
800 enrolled
UNICANCER
Accord Healthcare, Inc. · collabBelgian Group of Digestive Oncology · collabCancer Research UK · collabCancer Research UK & UCL Cancer Trials Centre · collabNational Cancer Institute, France · collabPierre Fabre Medicament · collabServier · collabTaiho Oncology, Inc. · collabZymeworks BC Inc. · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-07-18
- Primary completion
- 2027-06
- Completion
- 2028-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Binimetinib | Small molecule | 45 mg | — |
| Comparator | Cisplatin | Other / unclassified | 25 mg/m2 | Intravenous |
| Subject | Encorafenib | Small molecule | 450 mg | — |
| Subject | Futibatinib | Small molecule | 20 mg | — |
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Ivosidenib | Small molecule | 500 mg | — |
| Subject | Neratinib | Small molecule | 240 mg | — |
| Subject | Niraparib | Small molecule | 200 mg | — |
| Subject | Niraparib | Small molecule | 300 mg | — |
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | — |
| Subject | Zanidatamab | Monoclonal antibody | 1800 mg | — |
| Subject | Zanidatamab | Monoclonal antibody | 2400 mg | — |