Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma
← catalyst calendarSponsored by Eisai Inc. (industry) · 4523.T — their whole pipeline →. With Merck Sharp & Dohme LLC.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
1,069actual
Sites
183
Countries
Australia, Austria, Belgium +17
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 | 2016-10-13 | actual | When the study began enrolling |
| Primary completion | 2020-08-28 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-03-31 | estimated | The whole study's end, after follow-up |
| First posted | 2016-06-23 | estimated | When this record first appeared on the registry |
| Results posted | 2021-09-24 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-02-23 | 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: Lenvatinib
- Drug: Everolimus
- Drug: Pembrolizumab
- Drug: Sunitinib
Primary outcome
what the primary-completion date above is the date OFProgression-free Survival (PFS) by Independent Imaging Review (IIR)
measured From the date of randomization to the date of the first documentation of PD or date of death, whichever occurred first or up to data cutoff date 28 Aug 2020 (up to approximately 46 months)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2020-08-06 · 1.8 MB · Prot_000.pdf
Statistical Analysis Planposted 2020-08-14 · 756 KB · SAP_001.pdf
Publications
- PMID 39885377 — linked by the registry
- PMID 39739622 — linked by the registry
- PMID 39642774 — linked by the registry
- PMID 38582713 — linked by the registry
- PMID 38227898 — linked by the registry
- PMID 37664025 — linked by the registry
- PMID 37294085 — linked by the registry
- PMID 37146227 — linked by the registry
- PMID 36866412 — linked by the registry
- PMID 36858721 — linked by the registry
- PMID 35489363 — linked by the registry
- PMID 33616314 — 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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