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NCT05678673 · ClinicalTrials.gov registry record · Phase 3
Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma
A Phase 3 study of Non-Clear Cell Renal Cell Carcinoma, sponsored by Exelixis.
- Active
- Registry status
- Phase 3
- Development phase
- 317
- Enrollment target
- 20
- Study locations
NCT05678673: Active Phase 3 study of Non-Clear Cell Renal Cell Carcinoma, sponsored by Exelixis.
NCT05678673 is a Phase 3 study of Non-Clear Cell Renal Cell Carcinoma that is active but no longer recruiting, run by Exelixis. The registered enrollment target is 317 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05678673, a Phase 3 study of Non-Clear Cell Renal Cell Carcinoma, is active but no longer recruiting, sponsored by Exelixis.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 317 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG XL092
- DRUG Sunitinib Malate
Study Locations (20)
Other
- Exelixis Clinical Site #44 - Buenos Aires
- Exelixis Clinical Site #35 - CABA
- Exelixis Clinical Site #90 - Córdoba
- Exelixis Clinical Site #51 - Santa Fe
New South Wales
- Exelixis Clinical Site #94 - Albury
- Exelixis Clinical Site #97 - Camperdown
- Exelixis Clinical Site #98 - Liverpool
- Exelixis Clinical Site #95 - Macquarie
California
- Exelixis Clinical Site #1 - Duarte
- Exelixis Clinical Site #164 - Newport Beach
- Exelixis Clinical Site #162 - San Francisco
New York
- Exelixis Clinical Site #161 - Buffalo
- Exelixis Clinical Site #58 - New York
- Exelixis Clinical Site #15 - New York
Colorado
- Exelixis Clinical Site #163 - Aurora
Florida
- Exelixis Clinical Site #55 - Jacksonville
Ohio
- Exelixis Clinical Site #42 - Cleveland
Texas
- Exelixis Clinical Site #31 - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 317 participants |
| Start Date | 2023-01-01 |
| Est. Completion | 2028-06 |
| Phase | Phase 3 |
What the registry record for NCT05678673 still lists
NCT05678673 is an interventional study that assigns participants to a tested intervention. The registered 317 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower).
The record links to 1 condition, with Non-Clear Cell Renal Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT05678673 names 20 study sites across 10 states, led by Other, New South Wales, California.
Frequently Asked Questions
What is clinical trial NCT05678673 about?
NCT05678673 is a clinical study titled "Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma". 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.
What is the current status of trial NCT05678673?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 317 participants. The study started on 2023-01-01. Estimated completion is 2028-06.
What conditions does trial NCT05678673 study?
This clinical trial studies the following conditions: Non-Clear Cell Renal Cell Carcinoma.
What interventions are being tested in trial NCT05678673?
The interventions under investigation include: Nivolumab (DRUG), XL092 (DRUG), Sunitinib Malate (DRUG).
Who is sponsoring clinical trial NCT05678673?
This trial is sponsored by Exelixis, which has 48 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05678673 being conducted?
This trial has 20 study locations across California, Colorado, Florida, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05678673's enrollment target sits among peer trials
317 1090th of 2000 higher than 911 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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