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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 and is divided into two groups. Group 1 is for people who have never had cancer treatment before. Group 2 is for people who have had cancer treatment before. People in both groups will get the new treatment through an IV.

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 CR or PR as Assessed by the Investigator According Modified RECIST

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 Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Secondary outcome measures

DOR as Assessed by the Investigator According to Modified RECIST

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

+13 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 2: Participants With Second-line or Beyond TreatmentsExperimental Treatment1 Intervention

Participants with advanced disease who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting will receive atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit 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

2,429 Previous Clinical Trials

1,089,092 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,199 Previous Clinical Trials

888,192 Total Patients Enrolled

Frequently Asked Questions

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

Are we still able to sign people up for this experiment?

"This study has since closed recruitment and is no longer looking for patients that fit the criteria. The trial was originally posted on May 31st, 2014 but was updated as recently as September 7th, 2022. There are presently 393 trials actively admitting patients with urinary bladder cancer and 356 studies for Atezolizumab recruiting participants."

Answered by AI

What are some other instances in which Atezolizumab has been tested?

"The first clinical trial for atezolizumab was conducted in 2008 by Illinois Cancer Care. As of now, there are 79 completed trials and 356 that are still recruiting patients. Many of these active studies are based in San Marcos, California."

Answered by AI

Does this research build on previous findings?

"Atezolizumab has been the focus of 356 active studies since its inception in 2008. These studies have taken place across 74 countries and 1665 cities. The initial study, sponsored by Hoffmann-La Roche, involved 720 patients and completed its Phase 2 drug approval stage. Since then, 79 additional studies have been conducted."

Answered by AI

What are the dangers associated with Atezolizumab?

"Atezolizumab is a Phase 2 medication, so while there is some evidence suggesting it is safe, Power has given it a score of 2 because there are no clinical trials demonstrating its efficacy."

Answered by AI

Are there any limitations on how many people can be a part of this research?

"Unfortunately, this trial is no longer enrolling new patients. Although, if you 393 other trials for urinary bladder cancer or 356 for Atezolizumab that are still recruiting participants."

Answered by AI

What are the most common conditions that Atezolizumab is used to treat?

"Atezolizumab, which is most often used to treat small cell lung cancer, can also be an effective form of treatment for postoperative patients with non-small cell lung carcinoma."

Answered by AI

At how many research centers is this trial being conducted?

"In addition to the 3 main sites of Kaiser Permanente - San Marcos, USC Norris Cancer Center and UCSF; this study is also being conducted in 54 other locations throughout California, Massachusetts, Connecticut and elsewhere."

Answered by AI

Recent research and studies

Pharmacology Research & PerspectivesJournal

Pan‐cancer Population Pharmacokinetics and Exposure‐safety and ‐efficacy Analyses of Atezolizumab in Patients with High Tumor Mutational Burden

Shemesh, Colby S., Phyllis Chan, Fatema A. Legrand, David S. Shames, Meghna Das Thakur, Jane Shi, Lorna Bailey, et al.. 2020. “Pan‐cancer Population Pharmacokinetics and Exposure‐safety and ‐efficacy Analyses of Atezolizumab in Patients with High Tumor Mutational Burden”. Pharmacology Research & Perspectives. Wiley. doi:10.1002/prp2.685.

Journal of Clinical OncologyJournal

Alterations in DNA Damage Response and Repair Genes as Potential Marker of Clinical Benefit from PD-1/PD-L1 Blockade in Advanced Urothelial Cancers

Teo, Min Yuen, Kenneth Seier, Irina Ostrovnaya, Ashley M. Regazzi, Brooke E. Kania, Meredith M. Moran, Catharine K. Cipolla, et al.. 2018. “Alterations in DNA Damage Response and Repair Genes as Potential Marker of Clinical Benefit from PD-1/PD-L1 Blockade in Advanced Urothelial Cancers”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2017.75.7740.

European UrologyJournal

Atezolizumab in Platinum-treated Locally Advanced or Metastatic Urothelial Carcinoma: Outcomes by Prior Number of Regimens

Perez-Gracia, Jose Luis, Yohann Loriot, Jonathan E. Rosenberg, Thomas Powles, Andrea Necchi, Syed A. Hussain, Rafael Morales-Barrera, et al.. 2018. “Atezolizumab in Platinum-treated Locally Advanced or Metastatic Urothelial Carcinoma: Outcomes by Prior Number of Regimens”. European Urology. Elsevier BV. doi:10.1016/j.eururo.2017.11.023.

Annals of OncologyJournal