Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma
Condition(s) studied
Investigational drug(s) / intervention(s)
XL092: Specified doses on specified days
Nivolumab: Specified doses on specified days
Sunitinib Malate: Specified doses on specified days
Study summary
This is a multicenter, randomized (2:1), open-label, controlled Phase 3 trial of XL092 in combination with nivolumab versus sunitinib in subjects with unresectable, locally advanced or metastatic nccRCC who have not received prior systemic anticancer therapy.
Eligibility
Primary outcome measure(s)
- 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
Defined as the time from randomization to the earlier of either radiographic PD per RECIST 1.1 as determined by the BIRC or death from any cause - Objective response rate (ORR) as assessed by BIRC per RECIST 1.1 — Up to 24 months after the first subject is randomized
Defined as the proportion of subjects with the best overall response of complete response (CR) or partial response (PR) per RECIST 1.1 as determined by the BIRC that is confirmed at a follow-up assessment ≥ 28 days later
Trial sites (163)
| Facility | City | Region | Status |
|---|---|---|---|
| Exelixis Clinical Site #1 | Duarte | California | |
| Exelixis Clinical Site #164 | Newport Beach | California | |
| Exelixis Clinical Site #162 | San Francisco | California | |
| Exelixis Clinical Site #163 | Aurora | Colorado | |
| Exelixis Clinical Site #55 | Jacksonville | Florida | |
| Exelixis Clinical Site #161 | Buffalo | New York | |
| Exelixis Clinical Site #58 | New York | New York | |
| Exelixis Clinical Site #15 | New York | New York | |
| Exelixis Clinical Site #42 | Cleveland | Ohio | |
| Exelixis Clinical Site #31 | Dallas | Texas | |
| Exelixis Clinical Site #88 | Pilar | Buenos Aires | |
| Exelixis Clinical Site #89 | Viedma | Río Negro Province | |
| Exelixis Clinical Site #44 | Buenos Aires | Argentina | |
| Exelixis Clinical Site #35 | CABA | Argentina | |
| Exelixis Clinical Site #90 | Córdoba | Argentina | |
| Exelixis Clinical Site #51 | Santa Fe | Argentina | |
| Exelixis Clinical Site #94 | Albury | New South Wales | |
| Exelixis Clinical Site #97 | Camperdown | New South Wales | |
| Exelixis Clinical Site #98 | Liverpool | New South Wales | |
| Exelixis Clinical Site #95 | Macquarie | New South Wales | |
| Exelixis Clinical Site #92 | Sydney | New South Wales | |
| Exelixis Clinical Site #93 | Waratah | New South Wales | |
| Exelixis Clinical Site #99 | Douglas | Queensland | |
| Exelixis Clinical Site #100 | Elizabeth Vale | South Australia | |
| Exelixis Clinical Site #91 | Box Hill | Victoria | |
| Exelixis Clinical Site #96 | St Albans | Victoria | |
| Exelixis Clinical Site #14 | Chermside | Australia | |
| Exelixis Clinical Site #29 | South Brisbane | Australia | |
| Exelixis Clinical Site #102 | Porto Alegre | Rio Grande do Sul | |
| Exelixis Clinical Site #68 | Barretos | Brazil | |
| Exelixis Clinical Site #39 | Itajaí | Brazil | |
| Exelixis Clinical Site #69 | Passo Fundo | Brazil | |
| Exelixis Clinical Site #70 | Porto Alegre | Brazil | |
| Exelixis Clinical Site #78 | Porto Alegre | Brazil | |
| Exelixis Clinical Site #87 | Santo André | Brazil | |
| Exelixis Clinical Site #50 | São José do Rio Preto | Brazil | |
| Exelixis Clinical Site #101 | São Paulo | Brazil | |
| Exelixis Clinical Site #81 | São Paulo | Brazil | |
| Exelixis Clinical Site #85 | São Paulo | Brazil | |
| Exelixis Clinical Site #43 | São Paulo | Brazil |
+ 123 more sites — see the full list on the official registry below.
On this site
📄 Opdivo (nivolumab) drug profile →More Exelixis trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05678673 on ClinicalTrials.gov ↗ ← All trials in France