A Study of Atezolizumab (an Engineered Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) as Monotherapy or in Combination With Bevacizumab (Avastin®) Compared to Sunitinib (Sutent®) in Participants With Untreated Advanced Renal Cell Carcinoma

NCT01984242 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 305

Last updated 2019-12-23

Study results available
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Summary

This multicenter, randomized, open-label study will evaluate the efficacy, safety and tolerability of atezolizumab as monotherapy or in combination with bevacizumab versus sunitinib in participants with histologically confirmed, inoperable, locally advanced or metastatic renal cell carcinoma who have not received prior systemic therapy either in the adjuvant or metastatic setting.

Conditions

Interventions

DRUG

Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody

Atezolizumab will be administered according to the dosage schedule mentioned in the arm description.

DRUG

Bevacizumab

Bevacizumab will be administered according to the dosage schedule mentioned in the arm description.

DRUG

Sunitinib

Sunitinib will be administered according to the dosage schedule mentioned in the arm description.

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
2014-01-08
Primary Completion
2016-10-17
Completion
2019-01-08

Countries

  • United States
  • Czechia
  • France
  • Germany
  • Italy
  • Poland
  • Romania
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT01984242 on ClinicalTrials.gov