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Bladder CancerPhase 2NCT06059547

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

A Phase 2 study testing Nivolumab and Visugromab (CTL-002) in people with Bladder Cancer and Adult Solid Tumor, run by CatalYm GmbH at 4 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer, Adult Solid Tumor
What is being tested?
Nivolumab and Visugromab (CTL-002)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
31 participants
Where
4 sitesItaly
Study dates
6 Sep 2023to 5 Jun 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

4 sites in 1 country.

Italy4 sites

  • IRCCS Ospedale San Raffaele Hospital Vita-Salute San Raffaele University

    Milan, 20132

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Oncologia Medica

    Roma, 00168

  • A.O.U. Città della Salute e della Scienza di Torino

    Torino, 10126

Other trials in Italy

About this study

Official title: 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

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.

Being tested
Nivolumab, Visugromab (CTL-002), Placebo
Keywords
CTL-002, visugromab, GDF-15
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabDrug

    Biological, monoclonal antibody

  • Visugromab (CTL-002)Drug

    Biological, monoclonal antibody

  • PlaceboDrug

    Placebo (NaCl) for Visugromab (CTL-002)

Study groups in NCT06059547
Study groupRoleWhat they receive
Combination with PlaceboActive comparatorPlacebo + Checkpoint Inhibitor nivolumab
Receives: Drug: Nivolumab; Drug: Placebo
Combination with Visugromab/VerumExperimentalvisugromab (CTL-002) + Checkpoint Inhibitor nivolumab
Receives: Drug: Nivolumab; Drug: Visugromab (CTL-002)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological complete response rate

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

    Measured: min. 4 months

  2. 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

    Measured: min. 4 months

Secondary outcomes (13)

  1. Adverse Events

    Incidence of adverse events (related or unrelated to IMPs)

    Measured: min. 6 months

  2. Treatment related delay of surgery

    Treatment related delay of Radical Cystectomy/Re-TURBT > 8 weeks after last dose of IMP

    Measured: min. 6 months

  3. Cmax following the first dose of Visugromab (CTL-002)

    PK parameter from serum Visugromab (CTL-002) levels

    Measured: 1 day

  4. AUC following the first dose of Visugromab (CTL-002)

    PK parameter from serum Visugromab (CTL-002) levels

    Measured: 28 days

  5. Half-life of Visugromab (CTL-002)

    PK parameter from serum Visugromab (CTL-002) levels

    Measured: min. 3 months

  6. GDF-15 serum levels

    Measurement of concentration in peripheral blood

    Measured: 1 day

  7. Pathological complete response rate

    Rate of participants with complete pathological responses after IMP treatment as determined by central independent pathological review

    Measured: min. 4 months

  8. 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

    Measured: Min. 4 months

  9. 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

    Measured: Min. 4 months

  10. 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.

    Measured: 12 months after Radical Cystectomy/Re-TURBT

  11. 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.

    Measured: 15 months

  12. 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.

    Measured: 12 months after Radical Cystectomy/Re-TURBT

  13. Visugromab-induced anti-drug antibodies (ADA) development.

    The number and percentage of participants with any detectable ADA after first IMP administration

    Measured: min. 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2023
  2. Study start6 Sep 2023
  3. Primary completion16 Oct 2025
  4. Study completion5 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06059547
Sponsor's protocol ID
CTL-002-002
Status last verified
Aug 2026
First submitted
23 Aug 2023
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Necchi A, Mercinelli C, Maiorano BA, Piacentini M, Cigliola A, Iacovelli R, Ciccarese C, Ligato C, Giannatempo P, Rametta A, Gontero P, Soria F, Schuberth-Wagner C, Wischhusen J, Rossler B, Metterlein M, Ries S, Ross T, Amin A, Dreker T, Hermann F, Lemke L, Klar K, Mitina O, Kamova A, Fettes P, Auckenthaler A, Rao S, Leo E, Lichtenegger FS. Neoadjuvant nivolumab with or without visugromab in muscle-invasive bladder cancer: the phase 2a GDFATHER-NEO trial. Nat Med. 2026 Oct 24. doi: 10.1038/s41591-026-04740-9. Online ahead of print.

    PubMed 42926233

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab and Visugromab (CTL-002) in people with Bladder Cancer and Adult Solid Tumor, run by CatalYm GmbH at 4 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response rate (time frame: min. 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06059547, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

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