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Brief Title: Neoadjuvant Immunotherapy in Combination With the Anti-GDF-15 Antibody Visugromab (CTL-002) for Treatment of Muscle Invasive Bladder Cancer
Official Title: A Multi-center Phase 2 Study of Neoadjuvant Immunotherapy in Combination With the Anti-GDF-15 Antibody Visugromab (CTL-002) for the Treatment of Muscle Invasive Bladder
Study ID: NCT06059547
Brief Summary: This is a multi-center, stratified and single-blinded Phase 2 study of neoadjuvant immunotherapy in combination with the antiGDF15 antibody visugromab (CTL-002) for the treatment of subjects with MIBC set to undergo radical Cystectomy (RC) who cannot receive or refuse to receive cisplatin-based chemotherapy.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
IRCCS Ospedale San Raffaele Hospital Vita-Salute San Raffaele University, Milano, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Oncologia Medica, Roma, , Italy
A.O.U. Città della Salute e della Scienza di Torino, Torino, , Italy
Azienda Ospedaliera Ordine Mauriziano di Torino Ospedale Umberto I , SCDU Oncologia, Torino, , Italy
Name: Frank Hermann, MD
Affiliation: CatalYm GmbH
Role: STUDY_DIRECTOR