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A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection | Clinical Trials | Clareo Health

TERMINATEDPHASE3

A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection

A Phase III, Open-Label, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Versus Observation as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Urothelial Carcinoma After Surgical Resection

NCT02450331•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This Phase III, open-label, randomized, multicenter study is to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with observation in participants with muscle-invasive UC who are at high risk for recurrence following resection. Eligible participants were randomized by a 1:1 ratio into atezolizumab group or control group.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed muscle-invasive UC (also termed transitional cell carcinoma) of the bladder or upper urinary tract (i.e., renal pelvis or ureters)
•For participants treated with prior neoadjuvant chemotherapy: tumor stage of ypT2-4a or ypN+ (ypT2-4 or ypN+ for participants with upper urinary tract UC) and M0
•For participants who have not received prior neoadjuvant chemotherapy: tumor stage of pT3-4a or pN+ (pT3-4 or pN+ for participants with upper urinary tract UC) and M0
•Representative formalin-fixed paraffin-embedded tumor specimens from surgical resection (i.e., radical cystectomy, nephroureterectomy, or lymph node dissection) in paraffin blocks (blocks preferred) or at least 15 unstained slides, with an associated pathology report, for central testing and determined to be evaluable for tumor programmed death-ligand 1 (PD-L1) expression prior to study enrollment
•Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) or magnetic resonance imaging scan of the pelvis, abdomen, and chest no more than 4 weeks prior to randomization
•Full recovery from cystectomy or nephroureterectomy within 14 weeks following surgery
•Eastern Cooperative Oncology Group performance status of less than or equal to (\</=) 2
•Life expectancy greater than or equal to (\>/=) 12 weeks
•Adequate hematologic and end-organ function
•For women who are not postmenopausal or surgically sterile: agreement to remain abstinent or use contraceptive methods that result in a failure rate of less than (\<) 1 percent (%) per year during the treatment period and for at least 5 months after the last dose of atezolizumab

Exclusion Criteria

•Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
•Adjuvant chemotherapy or radiation therapy for UC following surgical resection
•Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or five half-lives of the drug prior to enrollment
•Malignancies other than UC within 5 years prior to Cycle 1, Day 1
•Pregnancy or breastfeeding
•Significant cardiovascular disease
•Severe infections within 4 weeks prior to Cycle 1, Day 1
•Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1, Day 1
•History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
•Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
+6 more criteria

Locations (186)

HonorHealth Research Institute - Pima - Virginia G. Piper Cancer Care Network

Scottsdale, Arizona, United States

UCLA

Los Angeles, California, United States

USC Norris Cancer Center

Los Angeles, California, United States

Stanford University Medical Center

Palo Alto, California, United States

University Of Colorado

Aurora, Colorado, United States

The Urology Center of Colorado

Denver, Colorado, United States

Yale Cancer Center; Medical Oncology

New Haven, Connecticut, United States

Northwestern University Feinberg School Of Medicine

Chicago, Illinois, United States

University of Chicago; Hematology/Oncology

Chicago, Illinois, United States

University of Iowa Hospital & Clinic; Division of Hematology/Oncology

Iowa City, Iowa, United States

Key Dates

Start Date

October 5, 2015

Primary Completion Date

November 30, 2019

Completion Date

June 14, 2022

Last Updated

June 18, 2023

Enrollment

809

ACTUAL participants

Conditions

Carcinoma, Transitional Cell

Interventions

Atezolizumab

DRUG

A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

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COMPLETEDPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection

Inclusion Criteria

Exclusion Criteria

A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

Enzalutamide in Combination With Gemcitabine and Cisplatin in Bladder Cancer

Tesetaxel for Previously Treated Patients With Bladder Cancer

TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced Unresectable Transitional Cell Carcinoma of the Urothelium

Gemcitabine and Platinol Followed by Pemetrexed and Gemcitabine in Patients With Advanced or Metastatic Bladder Cancer