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Checkpoint Inhibitor
Atezolizumab for Bladder Cancer
Phase 2
Waitlist Available
Led By Peter C Black
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No other prior malignancy is allowed except for specified cases
Patients must have Zubrod performance status =< 2
Must not have
Patients must not be planning to receive concomitant other biologic therapy, radiation therapy, intravesical chemotherapy, surgery, or other anti-cancer therapy while on this protocol
Patients must not have received a live, attenuated vaccine within 4 weeks before registration or anticipation that such a live, attenuated vaccine will be required during the study and up to 5 months after the last dose of atezolizumab
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing how well atezolizumab works in treating patients with bladder cancer that has come back and has not responded to Bacillus Calmette-Guerin.
Who is the study for?
This trial is for adults with recurrent, non-muscle invasive bladder cancer that hasn't responded to BCG therapy. Eligible participants must have had all visible tumors removed recently and can't have muscle invasive bladder cancer or certain other cancers. They need normal blood counts, liver and kidney function, no severe allergies to Chinese hamster products, no recent immunosuppressive treatments or live vaccines, and cannot be pregnant.
What is being tested?
The trial is testing the effectiveness of Atezolizumab, a monoclonal antibody immunotherapy drug. It aims to see if this treatment can help the immune system fight off bladder cancer cells that have returned after failing to respond to previous BCG therapy.
What are the potential side effects?
Atezolizumab may cause side effects like fatigue, allergic reactions related to infusion processes, potential organ inflammation due to an overactive immune response, as well as increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not had any other cancer types, except for certain allowed cases.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I had surgery to remove all visible tumors within the last 60 days and can provide tissue samples.
Select...
My bladder cancer has returned, is not in the muscle, and was confirmed less than 60 days ago.
Select...
My cancer is mainly urothelial but may have some glandular or squamous parts.
Select...
My bladder cancer has not responded to BCG treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not planning to undergo any other cancer treatments while on this trial.
Select...
I haven't had a live vaccine in the last 4 weeks and won't need one during the study.
Select...
I haven't had any severe infections or been hospitalized for one in the last 28 days.
Select...
I do not have a history of specific lung conditions.
Select...
I do not have an active hepatitis B or C infection.
Select...
I do not have active tuberculosis.
Select...
I have not had a bone marrow or organ transplant.
Select...
I am not on a RANKL inhibitor or can stop it before starting atezolizumab.
Select...
I have never had radiation treatment for bladder cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Complete Response (CR) Rate in the Subset of Patients With Carcinoma in Situ (CIS)
Event-free Survival (EFS)
Secondary study objectives
Bladder Cancer-Specific Survival
Event-free Survival (EFS) in the Ta/T1 Subset
Progression-free Survival (PFS)
+2 moreOther study objectives
CR for the CIS subset
Immune signature expression
PD-L1 and CD8 expression
+1 moreSide effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
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%
Pneumonia
6%
Febrile neutropenia
6%
Lacrimation increased
6%
Abdominal pain
6%
Dry skin
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (atezolizumab)Experimental Treatment1 Intervention
Patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles (51 weeks) in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2016
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,907 Previous Clinical Trials
41,011,972 Total Patients Enrolled
Canadian Cancer Trials GroupNETWORK
131 Previous Clinical Trials
69,375 Total Patients Enrolled
Peter C BlackPrincipal InvestigatorSWOG Cancer Research Network
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Any side effects from my past surgery or bladder treatments have mostly gone away.I have not had any other cancer types, except for certain allowed cases.Your blood has enough infection-fighting white blood cells.My kidney function, measured by creatinine levels or clearance, is within the normal range.You need to have had an electrocardiogram (ECG) within 42 days before joining the study.If you have HIV, you can join the study if you meet certain rules.I am not pregnant or nursing and will use birth control during and after the study.I've had a cystoscopy within the last 21 days showing no visible tumor.I haven't had bladder cancer or specific urinary tract cancer in the last 2 years and have had recent scans to check for cancer spread.I am not a candidate for or have refused the standard bladder removal surgery.I can take care of myself but might not be able to do heavy physical work.I've had a urine test for cancer cells within the last 21 days.My bladder cancer returned as high-grade after being clear for 6 months post-BCG treatment.I haven't had chemotherapy or immunotherapy for bladder cancer, nor vaccines in the last 6 weeks.I am not planning to undergo any other cancer treatments while on this trial.I haven't had a live vaccine in the last 4 weeks and won't need one during the study.I haven't had any severe infections or been hospitalized for one in the last 28 days.I had a surgery for bladder cancer less than 2 months ago and the cancer hasn't reached the muscle layer.I had surgery to remove all visible tumors within the last 60 days and can provide tissue samples.You are allergic to Chinese hamster egg or ovaries.Your platelet count is at least 100,000 per microliter within the past 42 days.Your hemoglobin level should be at least 9 grams per deciliter within the last 42 days before joining the study.My bladder cancer has returned, is not in the muscle, and was confirmed less than 60 days ago.I do not have a history of specific lung conditions.I do not have an active hepatitis B or C infection.My cancer is mainly urothelial but may have some glandular or squamous parts.I haven't taken any drugs that weaken my immune system in the last 4 weeks.I do not have active tuberculosis.My bladder cancer has not responded to BCG treatment.Your total bilirubin level needs to be within a certain range, unless you have Gilbert's syndrome, in which case it can be slightly higher.Your AST or ALT levels should not be more than two times the upper limit of normal within 42 days before joining the study.I have not had a bone marrow or organ transplant.I am not on a RANKL inhibitor or can stop it before starting atezolizumab.I have never had radiation treatment for bladder cancer.I haven't needed antibiotics for an infection in the last 14 days.I haven't needed treatment for an autoimmune disease in the last two years.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (atezolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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