A Phase 3, Open-label, Randomized Study of Nivolumab Combined with Ipilimumab, or with Standard of Care Chemotherapy, versus Standard of Care Chemotherapy in Participants with Previously Untreated Unresectable or Metastatic Urothelial Cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501784-40-00

Acronym

CA209-901

Enrollment

701

Registered

2024-03-08

Start date

2017-05-26

Completion date

Unknown

Last updated

2026-01-26

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

Conditions

Untreated Unresectable or Metastatic Urothelial Cancer

Brief summary

Primary endpoint of OS in cisplatin-ineligible randomized participants, Primary endpoint of OS in PD-L1 positive (>= 1%) randomized participants by immunohistochemistry (IHC)

Detailed description

OS in all randomized participants, PFS by blinded independent central review (BICR) (using RECIST 1.1) in cisplatin-ineligible randomized participants, in PD-L1 positive (>=1%) randomized participants and in all randomized participants, European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in all randomized participants

Interventions

DRUGYERVOY 5 mg/ml concentrate for solution for infusion

DRUGCARBO-cell® 10 mg/ml Infusionslösung

DRUGKonzentrat zur Herstellung einer Infusionslösung

DRUGCisplatin NeoCorp 1 mg/ml - Konzentrat zur Herstellung einer Infusionslösung

DRUGCisplatin Teva® 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGGEMCI-cell® 38 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGGemcitabine 1 g Powder for Solution for Infusion

DRUGCarboplatin Bendalis 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGCISPLATIN-EBEWE

DRUG1 MG/ML

DRUGKONCENTRAT DO SPORZĄDZANIA ROZTWORU DO INFUZJI

DRUGCarbomedac® 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGGemcitabine 38 mg/ml Concentrate for Solution for Infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Primary endpoint of OS in cisplatin-ineligible randomized participants, Primary endpoint of OS in PD-L1 positive (>= 1%) randomized participants by immunohistochemistry (IHC)	—

Secondary

Measure	Time frame
OS in all randomized participants, PFS by blinded independent central review (BICR) (using RECIST 1.1) in cisplatin-ineligible randomized participants, in PD-L1 positive (>=1%) randomized participants and in all randomized participants, European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in all randomized participants	—

Countries

Czechia, Denmark, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Romania, Spain

Outcome results

None listed

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