Trials / Active Not Recruiting
Active Not RecruitingNCT05678673
Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma
A Randomized Open-Label Phase 3 Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 317 (actual)
- Sponsor
- Exelixis · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | XL092 | Specified doses on specified days |
| DRUG | Nivolumab | Specified doses on specified days |
| DRUG | Sunitinib Malate | Specified doses on specified days |
Timeline
- Start date
- 2023-01-01
- Primary completion
- 2025-07-01
- Completion
- 2028-06-01
- First posted
- 2023-01-10
- Last updated
- 2025-07-14
Locations
163 sites across 25 countries: United States, Argentina, Australia, Brazil, Bulgaria, Chile, Croatia, Czechia, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Malaysia, Netherlands, Poland, Singapore, Slovakia, South Korea, Spain, Thailand, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05678673. Inclusion in this directory is not an endorsement.