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PD-L1 Inhibitor

atezolizumab for Safety Concerns

Phase 2
Waitlist Available
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
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 2-2.5 years
Awards & highlights

Summary

This is a single arm phase II trial to (1) evaluate safety and toxicity profile of intravenous Atezolizumab (anti-PDL-1) administered in combination with TMT in patients with MIBC, (2) To determine the loco-regional control rate (LCR) of TMT combined with PDL-1 blockade.

Eligible Conditions
  • Safety Concerns

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-2.5 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
Safety profile of intravenous Atezolizumab (anti-PDL-1) administered in combination with TMT in patients with MIBC
Secondary study objectives
Bladder cancer therapy impact on quality of life
Complete response to TMT combined with PDL-1 blockade
Overall survival

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
9%
Neutrophil count decreased
9%
Rash
8%
Headache
8%
Dysgeusia
8%
Paraesthesia
7%
Pain in extremity
7%
Mucosal inflammation
7%
Back pain
7%
Peripheral sensory neuropathy
7%
Insomnia
6%
Abdominal pain
6%
Febrile neutropenia
6%
Lacrimation increased
6%
Dry skin
6%
Pneumonia
6%
Dizziness
5%
Malaise
5%
Urinary tract infection
5%
Weight decreased
5%
Haemoptysis
5%
Nail disorder
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
4%
Productive cough
3%
Upper respiratory tract infection
3%
Pruritus
2%
Influenza like illness
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
1%
Syncope
1%
Dehydration
1%
Atrial fibrillation
1%
Lower respiratory tract infection
1%
Lung infection
1%
Respiratory tract infection
1%
Acute kidney injury
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Depression
1%
Musculoskeletal chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: atezolizumabExperimental Treatment1 Intervention
Atezolizumab will be given during trimodal therapy, and every 3 weeks for 16 cycles or until disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
FDA approved

Find a Location

Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
461 Previous Clinical Trials
164,328 Total Patients Enrolled
Wassim Kassouf, MDStudy ChairMcGill University Health Centre/Research Institute of the McGill University Health Centre
~3 spots leftby Sep 2025
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