A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
701actual
Sites
135
Countries
Argentina, Australia, Brazil +15
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2017-07-23 | actual | When the study began enrolling |
| Primary completion | 2020-02-12 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-01-16 | estimated | The whole study's end, after follow-up |
| First posted | 2017-05-04 | actual | When this record first appeared on the registry |
| Results posted | 2022-04-26 | actual | When the sponsor posted results to the registry |
| Record updated | 2025-06-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Renal Cell Carcinoma
Interventions
- Biological: Nivolumab — also filed as Opdivo, BMS-936558
- Drug: Cabozantinib — also filed as Cabometyx
- Drug: Sunitinib — also filed as Sutent
- Biological: Ipilimumab — also filed as Yervoy, BMS-734016
Primary outcome
what the primary-completion date above is the date OFProgression Free Survival (PFS)
measured From randomization date to date of first documented tumor progression or death, whichever occurs first (Up to 31 months)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2019-05-03 · 5.1 MB · Prot_002.pdf
Statistical Analysis Planposted 2019-12-11 · 2.4 MB · SAP_003.pdf
Publications
- PMID 42605077 — linked by the registry
- PMID 41617395 — linked by the registry
- PMID 41239083 — linked by the registry
- PMID 40998092 — linked by the registry
- PMID 39452894 — linked by the registry
- PMID 38642472 — linked by the registry
- PMID 37431849 — linked by the registry
- PMID 37146227 — linked by the registry
- PMID 36625894 — linked by the registry
- PMID 36327527 — linked by the registry
- PMID 35688173 — linked by the registry
- PMID 35032437 — linked by the registry
- PMID 34980597 — linked by the registry
- PMID 33657295 — linked by the registry
- PMID 33058158 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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