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Checkpoint Inhibitor
Atezolizumab + Chemotherapy for Bladder Cancer
Phase 2
Recruiting
Led By Jean Hoffman-Censits, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years old at time of consent
Agreement for men to remain abstinent or use contraceptive measures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4.5 years
Awards & highlights
Study Summary
This trial is testing a new cancer treatment combining atezolizumab, platinum, and etoposide for patients with locally advanced urothelial cancer. The goal is to see if this new treatment can help patients achieve a pathologic complete response (no cancer cells remaining) at cystectomy (surgery to remove the bladder).
Who is the study for?
This trial is for adults with small cell bladder cancer who haven't had prior systemic treatment for it. They must be fit enough for chemo, immunotherapy, and surgery, have a performance status of 0 or 1, and agree to use birth control. A tumor sample is needed before joining. People with recent other cancers, severe allergies to drugs in the study, active infections like HIV or hepatitis B, or certain heart conditions can't join.Check my eligibility
What is being tested?
The trial tests atezolizumab combined with platinum (carboplatin or cisplatin) and etoposide chemotherapy in patients undergoing cystectomy (bladder removal surgery). It's a Phase II study focusing on how many patients achieve no sign of cancer after this combination therapy.See study design
What are the potential side effects?
Possible side effects include immune-related reactions that may affect organs; infusion reactions from the drug entering the body; blood disorders; fatigue; increased risk of infections due to weakened immunity; kidney problems especially if using cisplatin which requires good kidney function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at least 18 years old.
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I agree to either not have sex or use birth control.
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I need a new biopsy for testing if my stored cancer tissue isn't suitable.
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My bladder cancer is confirmed and aggressive, with or without urothelial cancer.
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I am fully active or can carry out light work.
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I am healthy enough for cancer treatments like chemotherapy, immunotherapy, and surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathologic complete response (ypCR) at cystectomy
Secondary outcome measures
1-year overall survival rate (1-yr OS)
2-year overall survival rate (2-yr OS)
Disease Free Survival
+4 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%
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
Trial Design
1Treatment groups
Experimental Treatment
Group I: Atezolizumab with Platinum and Etoposide, followed by cystectomy.Experimental Treatment5 Interventions
The study population will include male and female patients over the age of 18 with invasive (cT1-cT4) small cell / neuroendocrine carcinoma of the bladder (MIBC), with or without urothelial cancer component, who are eligible for platinum based chemotherapy and immunotherapy. All patients will be fit to undergo surgical resection of their cancer by cystectomy. Patients with resectable N1 disease within the true pelvis are eligible.
Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 mg Day 1 of every 21 day cycle with chemotherapy x 4 cycles. Following cystectomy, Atezolizumab maintenance Q 21 days will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status (e.g., symptomatic deterioration such as pain secondary to disease), or up to 1 year (e.g., 16 cycles).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Carboplatin
2014
Completed Phase 3
~6670
Cisplatin
2013
Completed Phase 3
~1940
Etoposide
2010
Completed Phase 3
~2440
Cystectomy
2014
Completed Phase 2
~120
Find a Location
Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
558 Previous Clinical Trials
32,857 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,540 Previous Clinical Trials
567,866 Total Patients Enrolled
Jean Hoffman-Censits, MDPrincipal InvestigatorJohns Hopkins University
2 Previous Clinical Trials
34 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My bladder cancer is confirmed and aggressive, with or without urothelial cancer.I have received treatment for small-cell bladder cancer before.You must have a negative HIV test, unless there are specific reasons why this doesn't apply to you.I am taking steroids for COPD, asthma, low blood pressure, or adrenal issues.I have had a previous transplant of stem cells or an organ.I am currently on medication for hepatitis B.I haven't taken certain immune system affecting drugs recently.You have a current or past autoimmune disease or immune deficiency, with some specific exceptions.My cancer has spread to my brain or its coverings.I haven't had major heart problems in the last 3 months.You are allergic to certain ingredients in atezolizumab or other medications.You have had serious allergic reactions to certain medications or their ingredients in the past.I am at least 18 years old.I agree to either not have sex or use birth control.I have not had cancer other than small cell bladder cancer in the last 5 years.I have high calcium levels in my blood that are causing symptoms.I have lung conditions or signs of lung inflammation on a recent chest scan.I have not had a severe infection in the last 4 weeks.I have no health issues that prevent me from taking new medications.I have not received a live vaccine in the last 4 weeks.You tested negative for hepatitis B surface antigen (HBsAg) during screening.I have active tuberculosis.I am fully active or can carry out light work.I can provide a tumor sample in a paraffin block or at least 15 slides for the study.I need a new biopsy for testing if my stored cancer tissue isn't suitable.I have had chemotherapy for bladder cancer before.I had bladder radiotherapy less than 4 weeks ago or haven't recovered from its side effects.I have been treated with immune checkpoint inhibitors before.I have not had major surgery or minor procedures within the last week.I haven't taken certain medications or therapies recently.I am healthy enough for cancer treatments like chemotherapy, immunotherapy, and surgery.I have cancer in the upper part of my urinary system.I have another cancer besides non-melanoma skin cancer or prostate cancer.I have pain from my cancer that isn't managed well.My recent blood and organ function tests are within normal ranges.My kidney function is good enough for treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Atezolizumab with Platinum and Etoposide, followed by cystectomy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are included in this clinical trial at its peak?
"According to the clinicaltrials.gov website, this study is enrolling patients and was last updated on 27 June, 2022. They are recruiting 63 individuals from 2 hospitals or clinics."
Answered by AI
Could you please explain the possible dangers of Atezolizumab for patients?
"While Phase 2 trials are not as conclusive as later stages, there is some data to support the safety of Atezolizumab."
Answered by AI
Are people still able to sign up and participate in this experiment?
"The most recent information on clinicaltrials.gov points to this study actively recruiting participants. This trial, which is looking for 63 individuals at 2 locations, was first posted on 6/27/2022."
Answered by AI
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