C5731001 - An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination with Pembrolizumab Versus Chemotherapy in Subjects with Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma that Expresses HER2 (IHC 1+ and Greater)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501105-12-00

Acronym

SGNDV-001/KN-D74

Enrollment

Registered

2024-06-12

Start date

2024-07-15

Completion date

Unknown

Last updated

2025-11-25

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

Conditions

Urothelial Carcinoma

Brief summary

PFS per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 by blinded independent central review (BICR), Overall survival (OS)

Detailed description

ORR per RECIST v1.1 by BICR, ORR per RECIST v1.1 by investigator assessment, DOR per RECIST v1.1 by BICR, DOR per RECIST v1.1 by investigator, DCR per RECIST v1.1 by BICR, DCR per RECIST v1.1 by investigator, PFS per RECIST v1.1 by investigator, Type, incidence, relatedness, severity, and seriousness of adverse events (AEs), Type, incidence, and severity of laboratory abnormalities, Treatment discontinuation rate due to AEs, Electrocardiogram abnormalities, including changes in QTc, Effect on left ventricular ejection fraction, Change from baseline to Week 16 in European Organisation for Research and Treatment of Cancer core QoL questionnaire (EORTC QLQ C30) Global Health Status (GHS)/QoL Score (Items 29+30), Time to Deterioration in EORTC QLQ-C30 GHS/QoL Score (Items 29 + 30), Time to pain progression

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGGEMCITABINE

DRUGCARBOPLATIN

DRUGCISPLATIN

DRUGDisitamab Vedotin

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 by blinded independent central review (BICR), Overall survival (OS)	—

Secondary

Measure	Time frame
ORR per RECIST v1.1 by BICR, ORR per RECIST v1.1 by investigator assessment, DOR per RECIST v1.1 by BICR, DOR per RECIST v1.1 by investigator, DCR per RECIST v1.1 by BICR, DCR per RECIST v1.1 by investigator, PFS per RECIST v1.1 by investigator, Type, incidence, relatedness, severity, and seriousness of adverse events (AEs), Type, incidence, and severity of laboratory abnormalities, Treatment discontinuation rate due to AEs, Electrocardiogram abnormalities, including changes in QTc, Effect on left ventricular ejection fraction, Change from baseline to Week 16 in European Organisation for Research and Treatment of Cancer core QoL questionnaire (EORTC QLQ C30) Global Health Status (GHS)/QoL Score (Items 29+30), Time to Deterioration in EORTC QLQ-C30 GHS/QoL Score (Items 29 + 30), Time to pain progression	—

Measure

Time frame

—

Countries

Austria, Belgium, Czechia, France, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden

Outcome results

None listed

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