Status:
ACTIVE_NOT_RECRUITING
Neoadjuvant Immunotherapy Combined With the Anti-GDF-15 Antibody Visugromab to Treat Muscle Invasive Bladder Cancer
Lead Sponsor:
CatalYm GmbH
Conditions:
Bladder Cancer
Adult Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- Main
- 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
- 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.
- Following cardio-vascular risk factors:
- Myocardial infarction in the past 6 months before planned treatment start.
- Uncontrolled heart failure.
- Uncontrolled ventricular arrhythmia.
- A peri/myocarditis in the past 3 months before planned treatment start. Note: Stable atrial fibrillation is permissive with or without anticoagulation if there was no decompensation in the past 3 months before planned treatment start.
- Left ventricular ejection fraction (LVEF) \< 50% measured by echocardiogram or MUGA.
- QTcF ≥ 470 ms regardless of sex.
- 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).
Key Trial Info
Start Date :
September 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2026
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT06059547
Start Date
September 6 2023
End Date
October 16 2026
Last Update
December 11 2025
Active Locations (4)
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1
IRCCS Ospedale San Raffaele Hospital Vita-Salute San Raffaele University
Milan, Italy, 20132
2
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
3
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Oncologia Medica
Roma, Italy, 00168
4
A.O.U. Città della Salute e della Scienza di Torino
Torino, Italy, 10126