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Checkpoint Inhibitor

Atezolizumab for Urinary Tract Cancer

Phase 3
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
Participants with histologically documented locally advanced (tumor [T] 4b, any node [N]; or any T, N 2-3) or metastatic (M1, Stage IV) urothelial or non-urothelial carcinoma of the urinary tract
Participants must have progressed during or following treatment with at least one prior (and not more than 3) treatments for inoperable, locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to end of study (up to approximately 6 years)
Awards & highlights

Study Summary

This trial will study the safety of atezolizumab as treatment for people with locally advanced or metastatic cancer of the urinary tract. The trial will also study how well atezolizumab works and what biomarkers are associated with atezolizumab.

Eligible Conditions
  • Urinary Tract Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to end of study (up to approximately 6 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to end of study (up to approximately 6 years) 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 Adverse Events (AEs)
Secondary outcome measures
Change From Baseline in European Quality of Life (EuroQoL) Group 5-Dimension 5-Level (EQ-5D-5L) Self Report Questionnaire Health Utility Score
Change From Baseline in Health-Related Quality of Life (HRQoL), as Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score
DOR as Assessed by Modified RECIST
+8 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
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Pain in extremity
7%
Peripheral sensory neuropathy
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: AtezolizumabExperimental Treatment1 Intervention
Participants will receive atezolizumab every 3 weeks (Q3W) until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,064 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,198 Previous Clinical Trials
887,444 Total Patients Enrolled

Frequently Asked Questions

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

How many participants are needed for this research study?

"This study has already wrapped up recruitment and is no longer looking for patients. The listing was created on November 30th, 2016 but was updated as recently as August 25th, 2022. There are 29 other trials currently underway for urologic neoplasms and 357 clinical trials that involve Atezolizumab if you are seeking additional studies to participate in."

Answered by AI

Have medical professionals done anything like this before?

"Atezolizumab has a long history, with the first study being conducted in 2008. The original sponsor of this research was Hoffmann-La Roche. After the initial trial involving 720 patients, Atezolizumab received approval for Phase 2 clinical trials. As of now, there are 357 ongoing studies taking place in 1665 cities and 74 countries."

Answered by AI

Atezolizumab is most often given to patients for what reason?

"Atezolizumab is most commonly prescribed as a treatment for small cell lung cancer, however it has also been used to effectively treat other conditions such as non-small cell lung carcinoma and postoperative malignant neoplasms."

Answered by AI

Can you provide a list of other times Atezolizumab has been tested in a clinical setting?

"Atezolizumab was first studied in 2008 and there have been 79 completed studies on the medication to date. There are currently 357 clinical trials underway, with a significant number of them taking place in Calgary, Alberta."

Answered by AI

What are the most severe side effects associated with Atezolizumab?

"Atezolizumab's safety is estimated to be a 3. This rating comes from the fact that this is a Phase 3 trial, signifying that not only is there some evidence of efficacy, but also multiple rounds of data affirming its safety."

Answered by AI

Are people still being recruited for this clinical trial?

"This particular clinical trial, which was created on November 30th 2016 and last updated on August 25th 2022, is not currently looking for patients. Although this study has completed recruitment, there are 386 other studies that participants can sign up for."

Answered by AI

At how many distinct sites is this research being conducted?

"There are a total of 5 enrolling patients for this study, which includes Tom Baker Cancer Centre-Calgary in Calgary, Royal Victoria Hospital in Barrie, and Queen Elizabeth II Health Sciences Centre in Halifax. Additionally, there are 5 other locations where this trial is taking place."

Answered by AI
Recent research and studies
~120 spots leftby Apr 2025