A Phase 2 interventional study of Nivolumab and Visugromab (CTL-002) in Bladder Cancer and Adult Solid Tumor, sponsored by CatalYm GmbH. Completed at 4 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by CatalYm GmbH · Phase 2, Interventional, and Treatment
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.
1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.
This study's enrollment of 31 is below the median of 60 across 1,296 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →CatalYm GmbH is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Main Exclusion Criteria:
Following cardio-vascular risk factors:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo + Checkpoint Inhibitor nivolumab
Drug: Nivolumab · Drug: Placebo
visugromab (CTL-002) + Checkpoint Inhibitor nivolumab
Drug: Nivolumab · Drug: Visugromab (CTL-002)
Biological, monoclonal antibody
Biological, monoclonal antibody
Placebo (NaCl) for Visugromab (CTL-002)
Pathological complete response rate
Rate of participants with complete pathological responses after IMP treatment as determined by local pathologist review
Time frame: min. 4 months
Radiological response rate according RECIST
Rate of participants with radiological responses according to RECIST 1.1 prior Radical Cystectomy/Re-TURBT as assessed by the Investigator/Radiologist
Time frame: min. 4 months
Adverse Events
Incidence of adverse events (related or unrelated to IMPs)
Time frame: min. 6 months
Treatment related delay of surgery
Treatment related delay of Radical Cystectomy/Re-TURBT \> 8 weeks after last dose of IMP
Time frame: min. 6 months
Cmax following the first dose of Visugromab (CTL-002)
PK parameter from serum Visugromab (CTL-002) levels
Time frame: 1 day
AUC following the first dose of Visugromab (CTL-002)
PK parameter from serum Visugromab (CTL-002) levels
Time frame: 28 days
Half-life of Visugromab (CTL-002)
PK parameter from serum Visugromab (CTL-002) levels
Time frame: min. 3 months
GDF-15 serum levels
Measurement of concentration in peripheral blood
Time frame: 1 day
Pathological complete response rate
Rate of participants with complete pathological responses after IMP treatment as determined by central independent pathological review
Time frame: min. 4 months
Radiological response rate according RECIST
Rate of participants with radiological responses according to RECIST 1.1 prior Radical Cystectomy/Re-TURBT as assessed by the central independent review
Time frame: Min. 4 months
Major pathological response rate
Rate of participants with major pathological responses after IMP treatment as determined by local pathologist review or central independent pathological review
Time frame: Min. 4 months
Evaluation of EFS (Event-free Survival)
Event-free survival will be defined as the time from first IMP administration to one of the following: Radiographic disease progression precluding a curative intent surgery per RECIST v1.1 prior to RC/Re-TURBT. Initiation of neoadjuvant chemotherapy preceding RC/Re-TURBT as per Investigator decision. Inability to undergo RC/Re-TURBT due to the onset of treatment-related side effects. Inability to complete a curative intent surgery determined by the urologist at the time of RC/Re-TURBT (e.g., unresectable tumor, metastases discovered at RC). Local or distant recurrence assessed by cross-sectional imaging and/or biopsy after RC/Re-TURBT. Death from any cause. In this trial, participant refusal to undergo RC due to the evidence of complete or near-complete clinical response (assessed on cross-sectional imaging as previously described) will not be considered an event.
Time frame: 12 months after Radical Cystectomy/Re-TURBT
OS (Overall Survival)
Overall survival is defined as the time from the first IMP administration to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis will be censored at the date the participant was last known to be alive.
Time frame: 15 months
Evaluation of TTR (Time to Relapse)
Time to relapse will be measured from the time of RC/Re-TURBT until the day of documented relapse.
Time frame: 12 months after Radical Cystectomy/Re-TURBT
Visugromab-induced anti-drug antibodies (ADA) development.
The number and percentage of participants with any detectable ADA after first IMP administration
Time frame: min. 5 months
Tumor biopsy analysis
Time frame: min. 3 months
Evaluation of selected cytokine and chemokine concentration in peripheral blood
Time frame: min. 3 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2023 to primary completion in Oct 2025, 25 months.
Of 39 industry-sponsored phase 2 interventional studies under Urinary Bladder Neoplasms, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 52. This study's 25 months is below that.
Counting every sponsor, half of 194 studies reached it within 52 months; a quarter within 36 and three quarters within 91.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Visugromab
CatalYm GmbH