Clinical Trial

Neoadjuvant Immunotherapy Combined With the Anti-GDF-15 Antibody Visugromab to Treat Muscle Invasive Bladder Cancer

Active, Not Recruiting Phase 2
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Summary
This is a multi-center, stratified and single-blinded Phase 2 trial of neoadjuvant immunotherapy in combination with the anti-GDF15 antibody visugromab (CTL-002) for the treatment of participants with MIBC set to undergo radical Cystectomy (RC)/Re-TURBT who cannot receive or refuse to receive cisplatin-based chemotherapy.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-09-21; most recent amendment 2025-12-05.
Status change: Recruiting → Active, Not Recruiting 2025-03-28
Trial Details
NCT Number NCT06059547
Lead Sponsor CatalYm GmbH
Conditions Bladder Cancer, Adult Solid Tumor
Enrollment 31 participants
Start Date 2023-09-06
Primary Completion 2025-10-16 (estimated)
Study Completion 2026-10-16 (estimated)
Updated on ClinicalTrials.gov 2025-12-11