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NCT04338269 · ClinicalTrials.gov registry record · Phase 3
A Study of Atezolizumab in Combination With Cabozantinib Compared to Cabozantinib Alone in Participants With Advanced Renal Cell Carcinoma After Immune Checkpoint Inhibitor Treatment
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 3
- Development phase
- 522
- Enrollment target
NCT04338269: Clinical Trial Phase 3 study, sponsored by Hoffmann-La Roche.
NCT04338269 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 522 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04338269, a Phase 3 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 522 participants
- Enrollment target
Study Summary
This is a Phase III, multicenter, randomized, open-label study designed to evaluate the efficacy and safety of atezolizumab given in combination with cabozantinib versus cabozantinib alone in participants with inoperable, locally advanced, or metastatic renal cell carcinoma (RCC) who experienced radiographic tumor progression during or after Immune Checkpoint Inhibitor (ICI) treatment in the metastatic setting.
Primary Outcome
PFS was defined as the time from randomization to the first occurrence to PD, as determined by the IRF per RECIST v1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 millimeters (mm). Data for participants who did not expe
Interventions
- DRUG Atezolizumab
- DRUG Cabozantinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 522 participants |
| Start Date | 2020-07-28 |
| Est. Completion | 2025-03-24 |
| Phase | Phase 3 |
Why NCT04338269 stopped before completion
NCT04338269 is an interventional study that assigns participants to a tested intervention. The registered 522 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 (32% lower).
The record links to 0 conditions, and to 2 interventions - of which Atezolizumab is the first listed.
NCT04338269 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04338269 about?
NCT04338269 is a clinical study titled "A Study of Atezolizumab in Combination With Cabozantinib Compared to Cabozantinib Alone in Participants With Advanced Renal Cell Carcinoma After Immune Checkpoint Inhibitor Treatment". This is a Phase III, multicenter, randomized, open-label study designed to evaluate the efficacy and safety of atezolizumab given in combination with cabozantinib versus cabozantinib alone in participants with inoperable, locally advanced, or metastatic renal cell carcinoma (RCC) who experienced rad...
What is the current status of trial NCT04338269?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 522 participants. The study started on 2020-07-28. Estimated completion is 2025-03-24.
What interventions are being tested in trial NCT04338269?
The interventions under investigation include: Atezolizumab (DRUG), Cabozantinib (DRUG).
Who is sponsoring clinical trial NCT04338269?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04338269's enrollment target sits among peer trials
522 716th of 2000 higher than 1,284 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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