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Randomized, open-label phase II/III clinical trial of BT8009 in monotherapy or in combination in participants with locally advanced or metastatic urothelial cancer.
THE MAIN OBJECTIVE OF THIS RESEARCH STUDY IS TO DETERMINE WHETHER THE ADMINISTRATION OF BT8009 IN COMBINATION WITH PEMBROLIZUMAB WORKS AGAINST UROTHELIAL CANCER. A COMPARISON WILL BE MADE WITH TREATMENT WITH BASELINE CHEMOTHERAPY FOLLOWED BY TREATMENT WITH AVELUMAB. ALSO, THIS RESEARCH STUDY SEEKS TO KNOW THE SIDE EFFECTS OF BT8009 WHEN ADMINISTERED IN COMBINATION WITH PEMBROLIZUMAB.
Technical Summary
- PHASE II/III RANDOMIZED, OPEN-LABEL STUDY OF BT8009 IN MONOTHERAPY OR IN COMBINATION IN PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER (DURAVELO-2).
- Code EudraCT: 2023-504231-41-00
- Protocol number: BT8009-230
- Promoter: BicycleTx Limited
- Molecule/Drug: BT8009
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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