Tetra-modality Bladder Preservation Strategies in Muscle-invasive Bladder Cancer: TURBT+ Chemo/Immunotherapy+ Radiation Therapy+ Maintenance Immunotherapy vs. W&W
Lebanon80 participantsStarted 2025-04-15
Plain-language summary
The purpose of this study is to assess the efficacy and safety of adding the immunotherapy Avelumab as a fourth component, alongside tumor removal, chemotherapy, and radiation, to increase the chance of preserving the bladder in the treatment of muscle-invasive bladder cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Provision of signed and dated informed consent form (ICF) before any trial related procedures.
✓. Male or female participant with ≥ 18 years of age at time of consenting.
✓. Participant is able and willing to comply with the requirements of trial protocol.
✓. Pathologically (histologically or cytologically) and radiologically confirmed newly diagnosed MIBC (T2-T4 N0 M0) or recurrent previously NMIBC.
✕. Participant had received treatment for urothelial carcinoma, with any of the following anti-cancer therapies prior the first dose of trial treatment: systemic chemotherapy, targeted small molecule therapy, or radiation therapy.
What they're measuring
1
Efficacy of Avelumab in 2 non-comparative arms
Timeframe: 2 years
Trial details
NCT IDNCT06686381
SponsorAmerican University of Beirut Medical Center
✕. Participant had received prior treatment with any drug or antibody (anti-PD-1, anti-PD- L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody) targeting T-cell co-stimulation or checkpoint pathways.
✕. Participant who are not eligible to receive DDMVAC or Cisplatin-Gemzar.
✕. History of severe hypersensitivity to Avelumab or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI- CTCAE v5.0 Grade ≥ 3).