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NCT05012371 · ClinicalTrials.gov registry record · Phase 2
Lenvatinib With Everolimus Versus Cabozantinib for Second-Line or Third-Line Treatment of Metastatic Renal Cell Cancer
A Phase 2 study of Stage IV Renal Cell Cancer AJCC v8 and Stage III Renal Cell Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 3
- Study locations
NCT05012371: Active Phase 2 study of Stage IV Renal Cell Cancer AJCC v8 and Stage III Renal Cell Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
NCT05012371 is a Phase 2 study of Stage IV Renal Cell Cancer AJCC v8 and Stage III Renal Cell Cancer AJCC v8 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 90 participants, below the 148-participant average among 24 other Stage IV Renal Cell Cancer AJCC v8 trials with a reported enrollment target (39% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05012371, a Phase 2 study of Stage IV Renal Cell Cancer AJCC v8 and Stage III Renal Cell Cancer AJCC v8, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase II trial compares the effects of lenvatinib given in combination with everolimus to the effects of cabozantinib given alone in treating patients with renal cell cancer (RCC) that has spread to other parts of the body (metastatic) and that got worse on a previous PD-1/PD-L1 checkpoint inhibitor. Lenvatinib, everolimus, and cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
To be compared between lenvatinib + everolimus versus cabozantinib. Monitored using Bayesian optimal phase 2 (BOP2) design with time-to-event endpoint.
Conditions Studied
Interventions
- OTHER Questionnaire Administration
- DRUG Everolimus
- DRUG Cabozantinib
- DRUG Lenvatinib
Study Locations (3)
Florida
- Moffitt Cancer Center - Tampa
Texas
- M D Anderson Cancer Center - Houston
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2022-02-16 |
| Est. Completion | 2027-10-25 |
| Phase | Phase 2 |
What the registry record for NCT05012371 still lists
NCT05012371 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 148-participant average among 24 other Stage IV Renal Cell Cancer AJCC v8 trials with a reported enrollment target (39% lower).
The record links to 4 conditions, with Stage IV Renal Cell Cancer AJCC v8 appearing as the primary indexed condition, and to 4 interventions - of which Questionnaire Administration is the first listed.
NCT05012371 reports a single indexed study location in Florida, Texas, Virginia.
Frequently Asked Questions
What is clinical trial NCT05012371 about?
NCT05012371 is a clinical study titled "Lenvatinib With Everolimus Versus Cabozantinib for Second-Line or Third-Line Treatment of Metastatic Renal Cell Cancer". This phase II trial compares the effects of lenvatinib given in combination with everolimus to the effects of cabozantinib given alone in treating patients with renal cell cancer (RCC) that has spread to other parts of the body (metastatic) and that got worse on a previous PD-1/PD-L1 checkpoint inhi...
What is the current status of trial NCT05012371?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2022-02-16. Estimated completion is 2027-10-25.
What conditions does trial NCT05012371 study?
This clinical trial studies the following conditions: Stage IV Renal Cell Cancer AJCC v8, Stage III Renal Cell Cancer AJCC v8, Metastatic Clear Cell Renal Cell Carcinoma, Advanced Clear Cell Renal Cell Carcinoma.
What interventions are being tested in trial NCT05012371?
The interventions under investigation include: Questionnaire Administration (OTHER), Everolimus (DRUG), Cabozantinib (DRUG), Lenvatinib (DRUG).
Who is sponsoring clinical trial NCT05012371?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05012371 being conducted?
This trial has 3 study locations across Florida, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IV Renal Cell Cancer AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05012371's enrollment target sits among peer trials
90 8th of 24 higher than 17 of 24 other Stage IV Renal Cell Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Renal Cell Cancer AJCC v8 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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