A Multi-center Phase 2 Study of Neoadjuvant Immunotherapy in Combination With the Anti-GDF-15 Antibody Visugromab (CTL-002) for the Treatment of Muscle Invasive Bladder Cancer

CatalYm GmbH4 sites in 1 country31 target enrollmentSeptember 6, 2023

DrugsAnti-GDF-15 humanised hinge-stabilized IgG4 monoclonal antibody SODIO CLORURO BAXTER S.P.A. 0,9% Soluzione per infusione BMS936558 Visugromab (CTL-002)CTL-002 OPDIVO 10 mg/mL concentrate for solution for infusion.ABP 206 OPDIVO 10 mg/mL concentrate for solution for infusion., OPDIVO 10 mg/mL concentrate for solution for infusion., OPDIVO 10 mg/mL concentrate for solution for infusion., OPDIVO 10 mg/mL concentrate for solution for infusion.

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: CatalYm GmbH
Enrollment: 31
Locations: 4
Primary Endpoint: Pathological complete response rate
Status: Active, Not Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 MIBC set to undergo radical Cystectomy (RC)/Re-TURBT who cannot receive or refuse to receive cisplatin-based chemotherapy.

Registry

euclinicaltrials.eu

Start Date

September 6, 2023

End Date

October 16, 2026

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

CatalYm GmbH

Responsible Party

Principal Investigator

Petra Fettes

Scientific

CatalYm GmbH

Eligibility Criteria

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

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.
•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.

Outcomes

Primary Outcomes

Pathological complete response rate

Time Frame: min. 4 months

Rate of participants with complete pathological responses after IMP treatment as determined by local pathologist review

Radiological response rate according RECIST

Time Frame: min. 4 months

Rate of participants with radiological responses according to RECIST 1.1 prior Radical Cystectomy/Re-TURBT as assessed by the Investigator/Radiologist

Secondary Outcomes

Adverse Events(min. 6 months)
Treatment related delay of surgery(min. 6 months)
Cmax following the first dose of Visugromab (CTL-002)(1 day)
AUC following the first dose of Visugromab (CTL-002)(28 days)
Half-life of Visugromab (CTL-002)(min. 3 months)
GDF-15 serum levels(1 day)
Pathological complete response rate(min. 4 months)
Radiological response rate according RECIST(Min. 4 months)
Major pathological response rate(Min. 4 months)
Evaluation of EFS (Event-free Survival)(12 months after Radical Cystectomy/Re-TURBT)
OS (Overall Survival)(15 months)
Evaluation of TTR (Time to Relapse)(12 months after Radical Cystectomy/Re-TURBT)
Visugromab-induced anti-drug antibodies (ADA) development.(min. 5 months)