A Phase 3, Randomized, Open-Label Study of Nivolumab Combined with Ipilimumab Versus Sunitinib Monotherapy in Subjects with Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504761-23-00

Acronym

CA209-214

Enrollment

578

Registered

2023-08-31

Start date

2014-11-19

Completion date

2025-01-14

Last updated

2024-12-09

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

Conditions

Advanced or metastatic renal cell carcinoma

Brief summary

The primary endpoints are overall survival and progression free survival

Detailed description

Overall survival, Objective response rate, Duration of objective response, Overall safety and tolerability, Disease related symptom progression, Health related quality of life, Healthcare resource utilization, Adverse Event Incidence Rate, Progression-free survival

Interventions

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGSutent 12.5 mg hard capsules

DRUGIpilimumab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoints are overall survival and progression free survival	—

Secondary

Measure	Time frame
Overall survival, Objective response rate, Duration of objective response, Overall safety and tolerability, Disease related symptom progression, Health related quality of life, Healthcare resource utilization, Adverse Event Incidence Rate, Progression-free survival	—

Countries

Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Netherlands, Spain, Sweden

Outcome results

None listed

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