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

First listed
Sep 28, 2023
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 ]

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