NCT06059547

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

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 Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: CatalYm GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Cancer
• Adult Solid Tumor

Interventions

Type	Name	Description
DRUG	Nivolumab	Biological, monoclonal antibody
DRUG	Visugromab (CTL-002)	Biological, monoclonal antibody
DRUG	Placebo	Placebo (NaCl) for Visugromab (CTL-002)

Timeline

• Start date: 2023-09-06
• Primary completion: 2025-10-16
• Completion: 2026-10-16
• First posted: 2023-09-28
• Last updated: 2025-12-11

Locations

4 sites across 1 country: Italy

Regulatory

• FDA-regulated drug study