NCT06059547

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

Active, enrolled Phase 2 Last updated 11 December 2025

What this trial tests

Phase 2 trial testing Nivolumab in Bladder Cancer in 31 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

6 September 2023

Primary endpoint
16 October 2025

16 October 2026

Quick facts

Lead sponsor	CatalYm GmbH
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	31
Start date	6 September 2023
Primary completion	16 October 2025
Estimated completion	16 October 2026
Sites	4 locations across Italy

Drugs / interventions tested

• Nivolumab (nivolumab) — full drug profile →
• Visugromab (CTL-002) — full drug profile →
• Placebo

Conditions studied

• Bladder Cancer — all drugs for Bladder Cancer →
• Adult Solid Tumor — all drugs for Adult Solid Tumor →

Sponsor

CatalYm GmbH — full company profile →

Who can join

18 and older, any sex, with Bladder Cancer or Adult Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Comprehensive Review of Current Approaches in Bladder Cancer Treatment.
   Kumbham S, Md Mahabubur Rahman K, Foster BA, You Y. · · 2025 · cited 10× · PMID 39974639 · DOI 10.1021/acsptsci.4c00663
2. The Multifaceted Role of Growth Differentiation Factor 15 (GDF15): A Narrative Review from Cancer Cachexia to Target Therapy.
   Filippini DM, Romaniello D, Carosi F, Fabbri L, et al · · 2025 · cited 4× · PMID 40868185 · DOI 10.3390/biomedicines13081931
3. Interplay between sarcopenia, GDF-15, and the efficacy of nivolumab plus ipilimumab in patients with mismatch repair deficient metastatic colorectal cancer: final survival analysis of the phase II GERCOR NIPICOL study.
   Depotte L, Nay P, Borg C, Meurisse A, et al · · 2025 · cited 3× · PMID 40389373 · DOI 10.1136/jitc-2024-011220
4. Application of Immune Checkpoint Inhibitors in Cancer.
   Chen Z, Song Z, Den S, Zhang W, et al · · 2025 · cited 2× · PMID 40787068 · DOI 10.1002/mco2.70176
5. Neoadjuvant treatment patterns and biomarker selection in muscle-invasive bladder cancer.
   He W, Xie J, Wang Z, Wang M, et al · · 2025 · cited 1× · PMID 40591027 · DOI 10.1007/s12672-025-02796-6
6. New Horizons with Growth Differentiation Factor 15 in Oncology: From Cancer Cachexia and Tumour Immunity to Novel Therapeutic Strategies.
   Sugiyama K, Starling N, Chau I. · · 2025 · PMID 41294666 · DOI 10.3390/curroncol32110604
7. Decoding GDF15: Impact on prostate cancer metabolism, chemoresistance, and clinical applications.
   Zhu W, Xu H, Xiong X, Li Y, et al · · 2026 · PMID 41286571 · DOI 10.1097/cm9.0000000000003876
8. Geroscience in heart failure: the search for therapeutic targets in the shared pathobiology of human aging and heart failure.
   Castro C, Delwarde C, Shi Y, Roh J. · · 2025 · PMID 40297496 · DOI 10.20517/jca.2024.15