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Checkpoint Inhibitor

Atezolizumab for Bladder Cancer

Phase 2

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-year

Awards & highlights

Study Summary

This trial is testing a new cancer treatment for people with bladder cancer that has spread or come back after other treatments. The drug is given through an IV, and people are treated until the disease progresses or there are too many side effects.

Eligible Conditions

Bladder Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants With a Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) as Assessed by the Independent Review Facility (IRF) According to RECIST v1.1

Secondary outcome measures

DOR as Assessed by the Investigator According to RECIST v1.1

Duration of Response (DOR) as Assessed by the IRF According to RECIST v1.1

Maximum Serum Concentration (Cmax) of Atezolizumab

+10 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227

36%

Fatigue

35%

Alopecia

24%

Diarrhoea

23%

Nausea

23%

Decreased appetite

22%

Anaemia

20%

Asthenia

19%

Cough

19%

Dyspnoea

16%

Myalgia

15%

Neutropenia

14%

Constipation

14%

Oedema peripheral

12%

Pyrexia

11%

Neuropathy peripheral

11%

Vomiting

11%

Stomatitis

10%

Arthralgia

Rash

Neutrophil count decreased

Dysgeusia

Paraesthesia

Headache

Pain in extremity

Peripheral sensory neuropathy

Insomnia

Mucosal inflammation

Back pain

Pneumonia

Febrile neutropenia

Abdominal pain

Dry skin

Lacrimation increased

Dizziness

Haemoptysis

Weight decreased

Malaise

Urinary tract infection

Nail disorder

Productive cough

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Pruritus

Upper respiratory tract infection

Alanine aminotransferase increased

Aspartate aminotransferase increased

Influenza like illness

Respiratory tract infection

Musculoskeletal chest pain

Lower respiratory tract infection

Acute kidney injury

Depression

Lung infection

Dehydration

Chronic obstructive pulmonary disease

Atrial fibrillation

Syncope

Pleural effusion

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cohort 1: Treatment-naive Cisplatin Ineligible ParticipantsExperimental Treatment1 Intervention

Participants with advanced disease who are treatment-naive for advanced urothelial carcinoma and cisplatin ineligible will receive atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2017

Completed Phase 3

~5860

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,430 Previous Clinical Trials

1,089,278 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,613 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Atezolizumab considered a secure remedy for individuals?

"Our team has given Atezolizumab a rating of 2 on the safety scale. This is due to Phase 2 trial data indicating that there are some safety measures in place but no evidence supporting efficacy yet."

Answered by AI

In what medical context is Atezolizumab typically employed?

"Atezolizumab is a broad spectrum pharmacotherapeutic agent, capable of treating testicular cancer and malignant neoplasms like small cell lung carcinoma."

Answered by AI

Are recruitment efforts underway for this experiment?

"This clinical trial has concluded its patient recruitment. It was launched on May 31st 2014 and underwent an edit as of September 7th 2022. If you are searching for alternative trials, 372 studies currently require participants with urinary bladder cancer while 1007 trials need volunteers to test Atezolizumab."

Answered by AI

What precedent has been established in regards to Atezolizumab's efficacy through clinical research?

"Since its first study in 1997 at the City of Hope Comprehensive Cancer Center, 1006 trials have been completed with Atezolizumab. There are currently an additional 1007 ongoing clinical studies, primarily administered out of Montreal, Quebec."

Answered by AI

Where can I find information about the local implementation of this research endeavor?

"This medical study is running from McGill University, Sir Mortimer B Davis Jewish General Hospital in Montreal, the Karmanos Cancer Institute in Detroit and Ctr for Cancer and Blood Disorders in Fort Worth as well as a further 54 sites."

Answered by AI

What is the estimated sample size for this clinical experiment?

"This clinical trial is currently closed to new participants. First posted on May 31st 2014, the last update was September 7th 2022. Alternatively, 372 studies are available for those with urinary bladder cancer and 1007 trials are enrolling patients that hope to receive Atezolizumab treatment."

Answered by AI

Recent research and studies

European Urology OncologyJournal

Comparative Effectiveness of Non-cisplatin First-line Therapies for Metastatic Urothelial Carcinoma: Phase 2 Imvigor210 Study Versus US Patients Treated in the Veterans Health Administration

Vander Velde, Nancy, Annie Guerin, Raluca Ionescu-Ittu, Sherry Shi, Eric Q. Wu, Shih-Wen Lin, Ling-I Hsu, et al.. 2019. “Comparative Effectiveness of Non-cisplatin First-line Therapies for Metastatic Urothelial Carcinoma: Phase 2 Imvigor210 Study Versus US Patients Treated in the Veterans Health Administration”. European Urology Oncology. Elsevier BV. doi:10.1016/j.euo.2018.07.003.

Clinical Cancer ResearchJournal

Clinico-genomic Characterization of Patients with Metastatic Urothelial Carcinoma in Real-world Practice Identifies a Novel Bladder Immune Performance Index (BIPI)

Szabados, Bernadett, Mariano Ponz-Sarvisé, Robson Machado, Diego Saldana, Edward E. Kadel, Romain Banchereau, Fanny Bouquet, et al.. 2022. “Clinico-genomic Characterization of Patients with Metastatic Urothelial Carcinoma in Real-world Practice Identifies a Novel Bladder Immune Performance Index (BIPI)”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-22-0200.

clinicaltrials.govStudy

A Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (Cohort 1)

2014. "A Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (Cohort 1)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02951767.