A phase 3 study of nivolumab combined with Cabozantinib (ONO-4538-81/CA2099ER)

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 (ONO-4538-81/CA2099ER)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224017

Enrollment

630

Registered

2018-08-23

Start date

2017-08-22

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Previously Untreated, advanced or metastatic Renal Cell Carcinoma

Interventions

investigational material(s) Generic name etc : Nivolumab (ONO-4538/BMS-936558) INN of investigational material : Nivolumab Therapeutic category code : 429 Other antitumor agents Dosage and Administrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histological confirmation of RCC with a clear-cell component, including participants who may also have sarcomatoid features 2. Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC 3. No prior systemic therapy for RCC with the following exception : One prior adjuvant or neo adjuvant therapy for completley resectable RCC if such therapy did not include an agent that targets VEGF or VEGF receptors and if reccurence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy

Exclusion criteria

Exclusion criteria: 1. Any active CNS metastases 2. Any active, known or suspected autoimmune disease 3. Any condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization

Design outcomes

Primary

Measure	Time frame
efficacy Progression-free survival	—

Secondary

Measure	Time frame
safety efficacy Overall survival, Objective response rate, Safety	—

Countries

Europe, Japan, Middle East, North America, Oceania, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026