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Atezolizumab for High-Risk Bladder Cancer (IMvigor011 Trial)

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

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

Must not have

Patients with active hepatitis B virus or hepatitis C

History of specified pulmonary conditions or evidence of active pneumonitis on screening chest CT scan

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 10 years)

Awards & highlights

Pivotal 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.

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).

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have active hepatitis B or C.

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I have a history of lung conditions or signs of lung inflammation on a recent scan.

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I have a serious heart condition.

Timeline

Screening ~ 3 weeks3 visits

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 10 years)

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 10 years)

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 10 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Investigator-assessed DFS

Secondary study objectives

Incidence of Anti-Drug Antibodies (ADAs) to Atezolizumab

Investigator-Assessed Disease-Specific Survival

Investigator-Assessed Distant Metastasis-Free Survival

+4 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%

Stomatitis

11%

Vomiting

11%

Neuropathy peripheral

10%

Arthralgia

Neutrophil count decreased

Rash

Headache

Dysgeusia

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Febrile neutropenia

Pneumonia

Lacrimation increased

Abdominal pain

Dry skin

Dizziness

Malaise

Urinary tract infection

Weight decreased

Haemoptysis

Nail disorder

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Productive cough

Upper respiratory tract infection

Pruritus

Influenza like illness

Alanine aminotransferase increased

Aspartate aminotransferase increased

Syncope

Dehydration

Atrial fibrillation

Lower respiratory tract infection

Lung infection

Respiratory tract infection

Acute kidney injury

Chronic obstructive pulmonary disease

Pleural effusion

Depression

Musculoskeletal chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

2016

Completed Phase 3

~5860

0 / 15Eligibility criteria met