Trials / Terminated
TerminatedNCT04338269
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 III, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Atezolizumab Given in Combination With Cabozantinib Versus Cabozantinib Alone in Patients With Inoperable, Locally Advanced, or Metastatic Renal Cell Carcinoma Who Experienced Radiographic Tumor Progression During or After Immune Checkpoint Inhibitor Treatment
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 522 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Atezolizumab | Atezolizumab 1200 mg will be administered at a fixed dose on Day 1 of each 21-day cycle by IV infusion every 3 weeks. |
| DRUG | Cabozantinib | Cabozantinib 60 mg (three 20-mg tablets) administered orally once daily. |
Timeline
- Start date
- 2020-07-28
- Primary completion
- 2023-01-03
- Completion
- 2025-03-24
- First posted
- 2020-04-08
- Last updated
- 2026-03-19
- Results posted
- 2024-02-28
Locations
135 sites across 15 countries: United States, Argentina, Australia, Canada, Denmark, France, Germany, Greece, Italy, Japan, Poland, Russia, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04338269. Inclusion in this directory is not an endorsement.