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A Study of Atezolizumab in Combination With Cabozantinib Compared to Cabozantinib Alone in Participants With Advanced Renal Cell Carcinoma After Immune Checkpoint Inhibitor Treatment

NCT04338269 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 522

Last updated 2026-03-19

Study results available
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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

  • Carcinoma, Renal Cell

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-28
Primary Completion
2023-01-03
Completion
2025-03-24
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • Denmark
  • France
  • Germany
  • Greece
  • Italy
  • Japan
  • Poland
  • Russia
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04338269 on ClinicalTrials.gov