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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-06

Study Completion Date

2026-10-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Bladder Cancer Adult Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Participants will be stratified into four cohorts based on disease stage and PD-L1 expression. Within each cohort, participants are centrally and sequentially assigned to one of two treatment arms in a non-randomized, parallel assignment model.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Combination with Placebo

Placebo + Checkpoint Inhibitor nivolumab

Group Type ACTIVE_COMPARATOR

Nivolumab

Intervention Type DRUG

Biological, monoclonal antibody

Placebo

Intervention Type DRUG

Placebo (NaCl) for Visugromab (CTL-002)

Combination with Visugromab/Verum

visugromab (CTL-002) + Checkpoint Inhibitor nivolumab

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

Biological, monoclonal antibody

Visugromab (CTL-002)

Intervention Type DRUG

Biological, monoclonal antibody

Interventions

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Nivolumab

Biological, monoclonal antibody

Intervention Type DRUG

Visugromab (CTL-002)

Biological, monoclonal antibody

Intervention Type DRUG

Placebo

Placebo (NaCl) for Visugromab (CTL-002)

Intervention Type DRUG

Eligibility Criteria

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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).

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:

1. Myocardial infarction in the past 6 months before planned treatment start.
2. Uncontrolled heart failure.
3. Uncontrolled ventricular arrhythmia.
4. 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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No