A Phase 3, Randomized, Open-Label Study of Nivolumab Combined with Cabozantinib versus Sunitinib in Participants with Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509711-83-00

Acronym

CA209-9ER

Enrollment

265

Registered

2024-04-10

Start date

2017-10-27

Completion date

Unknown

Last updated

2025-07-16

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

Progression Free Survival (PFS) per blinded independent central review (BICR) of Arm A versus Arm C in all randomized participants

Detailed description

Overall Survival (OS) of Arm A versus Arm C, Objective Response Rate (ORR), Incidence of adverse events (AEs), Incidence of Serious Adverse Events (SAEs)

Interventions

DRUGSutent 12.5 mg hard capsules

DRUGIpilimumab

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGCABOMETYX 20 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression Free Survival (PFS) per blinded independent central review (BICR) of Arm A versus Arm C in all randomized participants	—

Secondary

Measure	Time frame
Overall Survival (OS) of Arm A versus Arm C, Objective Response Rate (ORR), Incidence of adverse events (AEs), Incidence of Serious Adverse Events (SAEs)	—

Countries

Czechia, Germany, Greece, Italy, Poland, Romania, Spain

Outcome results

None listed

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