Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
855actual
Sites
159
Countries
Argentina, Australia, Austria +22
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 | 2019-06-25 | actual | When the study began enrolling |
| Primary completion | 2022-01-31 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-01-31 | estimated | The whole study's end, after follow-up |
| First posted | 2019-05-03 | actual | When this record first appeared on the registry |
| Results posted | 2025-09-10 | actual | When the sponsor posted results to the registry |
| Record updated | 2025-09-10 | 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
- Drug: Cabozantinib — also filed as Cabometyx, XL184
- Biological: Nivolumab — also filed as Opdivo, BMS-936558
- Biological: Ipilimumab — also filed as Yervoy, BMS-734016
- Drug: Cabozantinib-matched placebo
Primary outcome
what the primary-completion date above is the date OFDuration of Progression-Free Survival (PFS) by Blinded Independent Radiology Committee (BIRC)
measured Up to 32 months
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2020-11-16 · 6.2 MB · Prot_000.pdf
Statistical Analysis Planposted 2022-04-11 · 2.3 MB · SAP_001.pdf
Publications
- PMID 37163623 — linked by the registry
- PMID 35383907 — linked by the registry
- PMID 34550754 — 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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