A Phase 2, open-label, multi-centre, multi-national interventional trial to evaluate the efficacy and safety of erdafitinib (ERDA) monotherapy and erdafitinib (ERDA) and cetrelimab (CET) combination as neoadjuvant treatment in cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC) whose tumours express FGFR gene alterations (SOGUG-NEOWIN)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512573-27-01

Acronym

SOGUG2020IEC(VEJ)11

Enrollment

Registered

2024-08-07

Start date

2023-12-11

Completion date

Unknown

Last updated

2025-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle-invasive bladder cancer (MIBC)

Brief summary

Pathological complete response (pCR), Pathological downstaging < ypT2

Detailed description

Rate of pathological downstaging (pDS), Event-free Survival rate, OS, ORR according to RECIST, after neoadjuvant treatment, Adverse events, Rate of delay of surgery (classed as a delay event if performed > 6 weeks after last dose of treatment)

Interventions

DRUGJNJ-42756493

DRUGJNJ-63723283

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Pathological complete response (pCR), Pathological downstaging < ypT2	—

Secondary

Measure	Time frame
Rate of pathological downstaging (pDS), Event-free Survival rate, OS, ORR according to RECIST, after neoadjuvant treatment, Adverse events, Rate of delay of surgery (classed as a delay event if performed > 6 weeks after last dose of treatment)	—

Countries

France, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026