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Atezolizumab for Transitional Cell Carcinoma (IMvigor010 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening up to approximately 80 months
Awards & highlights

IMvigor010 Trial Summary

This trial is testing whether the addition of atezolizumab to usual care after surgery for muscle-invasive bladder cancer reduces the risk of the cancer coming back, compared to usual care alone.

Eligible Conditions
  • Transitional Cell Carcinoma

IMvigor010 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening up to approximately 80 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening up to approximately 80 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
Disease-Free Survival (DFS), as Assessed by Investigator
Secondary outcome measures
Disease-Specific Survival (DSS), as Assessed by Investigator
Neoplasm Metastasis
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale Score
+6 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%
Peripheral sensory neuropathy
7%
Pain in extremity
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

IMvigor010 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AtezolizumabExperimental Treatment1 Intervention
Participants will receive intravenous (IV) atezolizumab on Day 1 of each 21-day cycle for 16 cycles (up to 1 year).
Group II: ObservationActive Control1 Intervention
Participants will undergo observation starting on Day 1 for 16 cycles (up to 1 year).
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
2,432 Previous Clinical Trials
1,089,414 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,131 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection
2015. "A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02450331.
~85 spots leftby Apr 2025
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