P3, N=6940, Completed, Serum Institute of India Pvt. Ltd. | Active, not recruiting --> Completed | Trial completion date: Dec 2025 --> Oct 2024 | Trial primary completion date: Dec 2025 --> Oct 2024
2 months ago
Trial completion • Trial completion date • Trial primary completion date
Intravesical recombinant BCG (rBCG: VPM1002BC) is applied weekly for three instillations followed by four cycles of neoadjuvant cisplatin/gemcitabine every 3 weeks. Atezolizumab 1200 mg every 3 weeks is started together with rBCG and given for four cycles...Results will be made available by publication. NCT04630730.
Plasma levels of TNFα significantly increased after treatment and blood-derived CD4+ T cells stimulated with PPD demonstrated significantly increased intracellular GM-CSF and IFN expression. The intravesical application of VPM1002BC is safe and well tolerated by patients and results in a potential Th1 weighted immune response.