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Atezolizumab for High-Risk Bladder Cancer (IMvigor011 Trial)

Phase 3
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Tumor PD-L1 expression per IHC that is evaluable by central testing of a representative tumor tissue specimen.
Full recovery from cystectomy and enrollment within 24 weeks following cystectomy. Minimum of 6 weeks must have elapsed from surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization to participant's first score decrease of >=10 points from baseline on eortc qlq-c30 physical function scale, role function scale, and the ghs/qol scale (up to approximately 81 months)
Awards & highlights

IMvigor011 Trial Summary

This trial will test if atezolizumab can help prevent recurrence of MIBC in people who are high risk and ctDNA positive.

Who is the study for?
This trial is for adults with high-risk muscle-invasive bladder cancer who've had their bladders surgically removed and are positive for ctDNA, indicating a risk of recurrence. They should be fully recovered from surgery, have a life expectancy of at least 12 weeks, and agree to use contraception if applicable. Exclusions include active tuberculosis, severe allergies to certain substances, autoimmune diseases (with some exceptions), other recent cancer therapies or clinical trials.Check my eligibility
What is being tested?
The study compares the effectiveness and safety of Atezolizumab (a type of immunotherapy) against a placebo in preventing cancer recurrence after bladder removal surgery. Participants will be randomly assigned to receive either Atezolizumab or a placebo without knowing which one they're getting (double-blind).See study design
What are the potential side effects?
Atezolizumab can cause immune-related side effects such as inflammation in various organs including lungs (pneumonitis), liver problems, skin reactions, hormone gland issues like thyroid disorders; it may also lead to infusion reactions during treatment administration.

IMvigor011 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor has been tested and shows PD-L1 protein.
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I have fully recovered from bladder removal surgery within the last 6 months.
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My blood test shows I have cancer-related genetic changes.
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My bladder cancer is confirmed by tissue analysis.
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My cancer stage fits specific criteria after surgery, with or without prior chemotherapy.
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I have not had, refused, or can't have cisplatin-based chemotherapy before surgery.
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My cancer's stage was determined after surgery.
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My recent scans show no signs of cancer in my body.
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I have had surgery to remove bladder cancer.
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I can take care of myself but might not be able to do heavy physical work.
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I have previously received platinum-based chemotherapy.
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My tumor has been tested for PD-L1 and the results are available.

IMvigor011 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization to participant's first score decrease of >=10 points from baseline on eortc qlq-c30 physical function scale, role function scale, and the ghs/qol scale (up to approximately 81 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization to participant's first score decrease of >=10 points from baseline on eortc qlq-c30 physical function scale, role function scale, and the ghs/qol scale (up to approximately 81 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Investigator-assessed DFS in Participants Who Are ctDNA Positive Within 24 Weeks of Cystectomy
Secondary outcome measures
IRF-Assessed DFS in All Randomized Participants
Incidence of Anti-Drug Antibodies (ADAs) to Atezolizumab
Independent Review Facility (IRF)-Assessed DFS in Primary Analysis Population
+9 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

IMvigor011 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm A: AtezolizumabExperimental Treatment1 Intervention
Atezolizumab will be administered intravenously at a dose of 1680 milligrams (mg) on Day 1 of each 28-day cycle for 12 cycles or up to 1 year (whichever occurs first). Atezolizumab will be discontinued in the event of IRF-assessed disease recurrence, unacceptable toxicity, withdrawal of consent, or study termination by the Sponsor.
Group II: Arm B: PlaceboPlacebo Group1 Intervention
Placebo will be administered intravenously on Day 1 of each 28-day cycle. Placebo will be discontinued in the event of IRF-assessed disease recurrence, unacceptable toxicity, withdrawal of consent, or study termination by the Sponsor.
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
2,430 Previous Clinical Trials
1,088,877 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,212 Total Patients Enrolled

Media Library

Atezolizumab Clinical Trial Eligibility Overview. Trial Name: NCT04660344 — Phase 3
Bladder Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04660344 — Phase 3
Bladder Cancer Research Study Groups: Arm B: Placebo, Arm A: Atezolizumab
Atezolizumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT04660344 — Phase 3

Frequently Asked Questions

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

Are there any participating Canadian hospitals for this research?

"The trial is being conducted out of Woodlands Medical Specialists, P.A. in Pensacola, Florida, Duke Cancer Institute in Durham, North carolina, Sansum Clinic in Santa Barbara, California, and 16 other locations."

Answered by AI

Has Atezolizumab undergone the necessary safety evaluations for public use?

"Atezolizumab's safety is supported by multiple rounds of testing and efficacy data, so it received a score of 3."

Answered by AI

Are there any available spots for volunteers in this clinical trial?

"Affirmative, the online clinical trials registry has this trial listed as open and recruiting participants. The 5/3/2021 posting date is noted, as well as the most recent update from 10/17/2022. 495 individuals are needed for the 16 different study sites."

Answered by AI

What is Atezolizumab used to target?

"Atezolizumab has potential to be an effective treatment for small cell lung cancer (sclc), malignant neoplasms, and non-small cell lung carcinoma."

Answered by AI

Are there other investigations that have utilized Atezolizumab?

"Atezolizumab was first trialed in 2008 by Can Care Assoc Med Group Inc; Beach Cities Offices. Since then, there have been 18339 completed trials with 359 active trials. Pensacola, Florida is hosting many of these active trials."

Answered by AI

Have other clinical trials like this one been conducted in the past?

"Atezolizumab was first trialled in 2008 by Genentech, Inc. and has been under study for 359 active trials in 1665 cities and 74 countries."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Cancer Care Centers of Brevard
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy
2021. "A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04660344.
All > Bladder Cancer
~124 spots leftby Mar 2025
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