Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma
NCT05678673 · STELLAR-304 Phase 3Active, not recruiting
- Lead sponsor
- Exelixis (Industry)
- Enrollment
- 317 (actual)
- Start date
- 1 Jan 2023
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 30 Jun 2028
- Last update posted
- 29 Jul 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- None
- Arms
- 2
Interventions
- XL092 Drug
- Nivolumab Drug
- Sunitinib Malate Drug
Conditions and primary outcome
- Non-Clear Cell Renal Cell Carcinoma
Primary outcome
Duration of Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), by Blinded Independent Radiology Committee (BIRC) (Approximately 27 months after the first subject is randomized); Objective response rate (ORR) as assessed by BIRC per RECIST 1.1 (Up to 24 months after the first subject is randomized)
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
1 on PubMedSTELLAR-304: a phase III study of zanzalintinib (XL092) plus nivolumab in advanced non-clear cell renal cell carcinoma.
Future oncology (London, England) · 2025 Mar
PubMed 40008409 (opens in a new tab)DOI 10.1080/14796694.2025.2458395 (opens in a new tab)
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT05678673 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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