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NCT06863311 · ClinicalTrials.gov registry record · Phase 2
Trial of Zanzalintinib (XL092) in Combination With Immunotherapy in Patients Who Progress on Adjuvant Therapy in Clear Cell RCC
A Phase 2 study of Clear Cell Renal Cell Carcinoma and Metastatic Renal Cell Carcinoma, sponsored by Karie Runcie.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 2
- Study locations
NCT06863311 is a Phase 2 study of Clear Cell Renal Cell Carcinoma and Metastatic Renal Cell Carcinoma that is actively recruiting participants, run by Karie Runcie. The registered enrollment target is 70 participants, below the 202-participant average among 45 other Clear Cell Renal Cell Carcinoma trials with a reported enrollment target (65% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT06863311, a Phase 2 study of Clear Cell Renal Cell Carcinoma and Metastatic Renal Cell Carcinoma, is actively recruiting participants, sponsored by Karie Runcie.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 2
- Study locations
Study Summary
The study population for this Phase 2 study will include men and women ≥ 18 with confirmed renal cell carcinoma who have progressed on adjuvant anti-PD-1/PD-L1 therapy, the current standard of care. Subjects will be randomized to Arm A or Arm B. Study treatment will be given in 28-day (4 week) cycles. Arm A treatment will consist of zanzalintinib (XL092) alone and will be taken once daily continuously (Day 1-Day 28). Arm B treatment will consist of XL092 plus nivolumab. XL092 will be taken once daily continuously (Day 1-Day 28) and nivolumab will be administered every 4 weeks (Day 1). Treatment will continue until progression by RECIST 1.1, toxicity, or other reasons as appropriate.
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG XL092
Study Locations (2)
Missouri
- Washington University School of Medicine - St Louis
New York
- Columbia University Irving Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2026-03-13 |
| Est. Completion | 2028-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06863311
The ClinicalTrials.gov registry entry for NCT06863311 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 202-participant average among 45 other Clear Cell Renal Cell Carcinoma trials with a reported enrollment target (65% lower). The listed sponsor is Karie Runcie, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Clear Cell Renal Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.
NCT06863311 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Missouri, New York.
Frequently Asked Questions
What is clinical trial NCT06863311 about?
NCT06863311 is a clinical study titled "Trial of Zanzalintinib (XL092) in Combination With Immunotherapy in Patients Who Progress on Adjuvant Therapy in Clear Cell RCC". The study population for this Phase 2 study will include men and women ≥ 18 with confirmed renal cell carcinoma who have progressed on adjuvant anti-PD-1/PD-L1 therapy, the current standard of care. Subjects will be randomized to Arm A or Arm B. Study treatment will be given in 28-day (4 week) cycle...
What is the current status of trial NCT06863311?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2026-03-13. Estimated completion is 2028-12.
What conditions does trial NCT06863311 study?
This clinical trial studies the following conditions: Clear Cell Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Advanced Renal Cell Carcinoma.
What interventions are being tested in trial NCT06863311?
The interventions under investigation include: Nivolumab (DRUG), XL092 (DRUG).
Who is sponsoring clinical trial NCT06863311?
This trial is sponsored by Karie Runcie, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06863311 being conducted?
This trial has 2 study locations across Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Clear Cell Renal Cell Carcinoma
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