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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
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517785-42-00
Acronym
WO41994
Enrollment
64
Registered
2024-11-01
Start date
2020-10-08
Completion date
2025-03-24
Last updated
2024-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal cell carcinoma (RCC)

Brief summary

1. Progression-free survival as assessed by Independent Review Facility (IRF), 2. Overall survival

Detailed description

1. Progression-free survival as assessed by investigators, 2. Investigator- and IRF-assessed objective response rate, 3. Investigator- and IRF-assessed duration of objective response, 4. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0, 5. Change from baseline in targeted vital signs, 6. Change from baseline in targeted clinical laboratory test results, 7. Atezolizumab concentrations at specified timepoints (for atezolizumab + cabozantinib arm), 8. Cabozantinib concentrations at specified timepoints, 9. Prevalence of anti-drug antibodies (ADAs) to atezolizumab at baseline and incidence of ADAs to atezolizumab during the study (for atezolizumab+ cabozantinib arm)

Interventions

DRUGTecentriq 1 200 mg concentrate for solution for infusion

Sponsors

F. Hoffmann-La Roche AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1. Progression-free survival as assessed by Independent Review Facility (IRF), 2. Overall survival

Secondary

MeasureTime frame
1. Progression-free survival as assessed by investigators, 2. Investigator- and IRF-assessed objective response rate, 3. Investigator- and IRF-assessed duration of objective response, 4. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0, 5. Change from baseline in targeted vital signs, 6. Change from baseline in targeted clinical laboratory test results, 7. Atezolizumab concentrations at specified timepoints (for atezolizumab + cabozantinib arm), 8. Cabozantinib concentrations at specified timepoints, 9. Prevalence of anti-drug antibodies (ADAs) to atezolizumab at baseline and incidence of ADAs to atezolizumab during the study (for atezolizumab+ cabozantinib arm)

Countries

Germany, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026