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

NCT06059547 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2025-12-11

No results posted yet for this study

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

Interventions

DRUG

Nivolumab

Biological, monoclonal antibody

DRUG

Visugromab (CTL-002)

Biological, monoclonal antibody

DRUG

Placebo

Placebo (NaCl) for Visugromab (CTL-002)

Sponsors & Collaborators

  • CatalYm GmbH

    lead INDUSTRY

Principal Investigators

  • Felix Lichtenegger, MD · CatalYm GmbH

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-06
Primary Completion
2025-10-16
Completion
2026-10-16
FDA Drug
Yes

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06059547 on ClinicalTrials.gov