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

Sponsor
CatalYm GmbH
Study ID
NCT06059547
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Biological, monoclonal antibody
  • Visugromab (CTL-002) — DRUG
    Biological, monoclonal antibody
  • Placebo — DRUG
    Placebo (NaCl) for Visugromab (CTL-002)

Study Details

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.

Key Dates

Start date
Sep 6, 2023
Status verified
Dec 2025
Primary completion
Oct 16, 2025
Completion
Oct 16, 2026

Study Design

Enrollment
31 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Combination with Placebo
    Placebo + Checkpoint Inhibitor nivolumab
  • Experimental: Combination with Visugromab/Verum
    visugromab (CTL-002) + Checkpoint Inhibitor nivolumab

Primary Outcome Measure

Pathological complete response rate [ Time Frame: min. 4 months ]

Related Studies