Neoadjuvant Immunotherapy in Combination With the Anti-GDF-15 Antibody Visugromab (CTL-002) for Treatment of Muscle Invasive Bladder Cancer

• Status: Recruiting
• Trial end date: 2025-08-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center, stratified and single-blinded Phase 2 study of neoadjuvant immunotherapy in combination with the antiGDF15 antibody visugromab (CTL-002) for the treatment of subjects with MIBC set to undergo radical Cystectomy (RC) who cannot receive or refuse to receive cisplatin-based chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CatalYm GmbH
• Treatments: Nivolumab

Criteria

Main Inclusion Criteria:

• Signed and dated informed consent, and able to comply with the study procedures and any locally required authorization.

• Male or female aged ≥ 18 years.

• Histopathologically confirmed urothelial carcinoma.

• Clinical Stage T2-T4aN0M0 MIBC.

• Ineligible for cisplatin therapy per modified Galsky criteria or refuses cisplatin-based chemotherapy.

• Eligible for radical Cystectomy.

• Pretreatment tumor material from transurethral resection of the bladder tumor (TURBT) must be available.

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

• Adequate organ function (bone marrow, hepatic, renal function and coagulation).

Main Exclusion Criteria:

• Pregnant or breastfeeding.

• Received prior radiotherapy on the bladder tumor.

• Received a partial cystectomy.

• Any prior systemic anti-cancer therapy including investigational agents and immunotherapy for bladder cancer.

• Pre-existing arrhythmia, uncontrolled angina pectoris, uncontrolled heart failure (NYHA) Grade IV, any myocardial infarction/coronary event, CNS-ischemic event and any thromboembolic event at any time < 6 months prior to Screening or presence of uncontrolled heart failure NYHA Grade III or higher.

• Left ventricular ejection fraction (LVEF) < 50% measured by echocardiogram or MUGA.

• QTcF > 450 ms for men or > 470 ms for women.

• Any active autoimmune requiring systemic immunosuppressive treatments.

• Any history of non-infectious pneumonitis < 6 months prior to Screening.

• Any active inflammatory bowel disease such as Crohn's disease or ulcerative colitis which are generally excluded or active autoimmunthyroiditis present < 6 months prior to Screening.

• History of CNS disease such as stroke, seizure, encephalitis, or multiple sclerosis (< 6 months prior to Screening).