A phase 3 study of nivolumab combined with Ipilimumab(ONO-4538-16)

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(ONO-4538-16)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222800

Enrollment

1070

Registered

2015-03-20

Start date

2014-10-13

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 ),Ipilimumab( BMS-734016 ) INN of investigational material : Nivolumab, Ipilimumab Therapeutic category code : 429 Other a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histological confirmation of RCC with a clear-cell component 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 history of or current CNS metastases. 2. Prior systemic treatment with VEGF or VEGF receptor targeted therapy.

Design outcomes

Primary

Measure	Time frame
efficacy Objective response rate, Progression-free survival, Overall survival	—

Secondary

Measure	Time frame
safety Safety	—

Countries

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

Outcome results

None listed

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