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Monoclonal Antibodies
Atezolizumab + Chemotherapy for Bladder Cancer
Phase 2
Waitlist Available
Led By Samuel Funt, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Histologically confirmed urothelial carcinoma of the bladder, ureter, urethra, or renal pelvis by the enrolling institution with a predominant urothelial component
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will compare the effects of atezolizumab when given before or after standard chemotherapy drugs in patients with advanced bladder cancer.
Who is the study for?
Adults with advanced bladder cancer that can't be surgically removed or has spread, who haven't had chemotherapy or immunotherapy for metastatic disease. They must have a life expectancy of at least 12 weeks, measurable disease amenable to biopsy, and agree to use effective contraception post-treatment. Excluded are those with prior transplants, heart disease class III/IV, certain recent treatments including investigational drugs and systemic steroids, known liver diseases or bone marrow disorders, active infections like HIV/Hepatitis B/C/TB, severe allergies to specific antibodies or proteins.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Atezolizumab (an immune therapy drug) combined with Gemcitabine and Cisplatin (chemotherapy drugs) in two different sequences: one where chemotherapy is given before Atezolizumab and another where it's given after. The goal is to see which sequence works better against metastatic bladder cancer.See study design
What are the potential side effects?
Atezolizumab may cause immune-related reactions affecting organs like lungs or intestines; infusion reactions; fatigue; skin issues; hormone gland problems such as thyroid disorders. Chemotherapy with Gemcitabine and Cisplatin can lead to blood cell count changes increasing infection risk; kidney damage; nausea/vomiting.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My cancer is confirmed to be mainly urothelial and affects my bladder, ureter, urethra, or renal pelvis.
Select...
My cancer is advanced or has spread to other parts of my body.
Select...
I am 18 years old or older.
Select...
My cancer can be measured and biopsied according to specific guidelines.
Select...
I agree to have two biopsies for research during my treatment.
Select...
I have enough tumor tissue available for PD-L1 testing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
overall response rate
Side 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%
Pain in extremity
7%
Peripheral sensory neuropathy
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
3Treatment groups
Experimental Treatment
Group I: Atezolizumab with Gemcitabine and CisplatinExperimental Treatment3 Interventions
Gemcitabine and Cisplatin for 2 cycles. One treatment cycle equals 21 days. After 2 cycles of Gemcitabine and Cisplatin patient will receive combined atezolizumab and Gemcitabine and Cisplatin for 4 cycles. All 6 treatment cycles will take approximately 18 weeks. If carboplatin is substituted for cisplatin, eGFR for dosing may be calculated by institutional standard formulas, at the discretion of the treating investigator.
Group II: Atezolizumab alone with Gemcitabine and CisplatinExperimental Treatment3 Interventions
Atezolizumab alone for 2 cycles. One treatment cycle equals 21 days. Then patient will receive combined atezolizumab and Gemcitabine and Cisplatin for 6 cycles. All 8 treatment cycles will take approximately 24 weeks. If carboplatin is substituted for cisplatin, eGFR for dosing may be calculated by institutional standard formulas, at the discretion of the treating investigator. This cohort is NO LONGER ACCRUING patients since 5/22/2018.
Group III: Atezolizumab alone for 1 cycle prior to gemcitabine, cisplatinExperimental Treatment3 Interventions
Atezolizumab alone for 1 cycle. One treatment cycle equals 21 days. After 1 cycle of atezolizumab the patients will receive combined atezolizumab and gemcitabine, cisplatin for 4 cycles. All 5 treatment cycles will take approximately 15 weeks. Cisplatin dose can be given on day 1 or split over days 1 and 8 at the investigator"s discretion. Once the split-dose cisplatin is used, it should be used for the remainder of the chemotherapy treatment course.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Gemcitabine
2017
Completed Phase 3
~2070
Cisplatin
2013
Completed Phase 3
~1940
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,588 Total Patients Enrolled
Ohio State UniversityOTHER
827 Previous Clinical Trials
502,719 Total Patients Enrolled
University of ChicagoOTHER
1,001 Previous Clinical Trials
817,698 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer treatment in the last 3 weeks.I have not had any other cancers in the last 5 years.I have been treated with drugs targeting PD-1 or PD-L1.I haven't taken any immune-boosting drugs in the last 6 weeks.I have a brain tumor or cancer that has spread to my brain and causes symptoms.My heart condition severely limits my daily activities.I have moderate to severe numbness, tingling, or muscle weakness.I have moderate to severe hearing loss.I am fully active or can carry out light work.I have a history of lung scarring or inflammation.I have a bone marrow disorder that may affect my treatment.I have not had major surgery in the last 28 days.I have not received a live vaccine in the last 4 weeks.I have a history of HIV or active hepatitis B or C.I have not had severe infections in the last 4 weeks.I have not had signs of infection in the last 2 weeks.I have taken antibiotics by mouth or IV within the last 2 weeks.My cancer is confirmed to be mainly urothelial and affects my bladder, ureter, urethra, or renal pelvis.My cancer is advanced or has spread to other parts of my body.I am 18 years old or older.My cancer can be measured and biopsied according to specific guidelines.My blood and organs are functioning well.I haven't taken any immune-weakening medications in the last 2 weeks.I have had a bone marrow or organ transplant in the past.I agree to have two biopsies for research during my treatment.I have enough tumor tissue available for PD-L1 testing.I have active tuberculosis.I am taking bisphosphonates for high calcium levels.I do not have any health issues that prevent me from taking experimental medications.I have a serious liver condition.I have had chemotherapy or immunotherapy for bladder cancer that has spread.
Research Study Groups:
This trial has the following groups:- Group 1: Atezolizumab alone with Gemcitabine and Cisplatin
- Group 2: Atezolizumab with Gemcitabine and Cisplatin
- Group 3: Atezolizumab alone for 1 cycle prior to gemcitabine, cisplatin
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.
Atezolizumab is often administered to treat which condition?
"Atezolizumab can be administered as a treatment to patients with urinary bladder, advanced testicular cancer, and small cell lung cancer (sclc)."
Answered by AI
Are new patients still being sought for this clinical trial?
"Although this study is no longer recruiting patients, that information found on clinicaltrials.gov, it was last updated on 7/11/2022. There are 1553 other trials that are currently looking for patients to enroll."
Answered by AI
Are there different sites where I can participate in this research?
"There are 9 recruitment sites for this trial, including Memorial Sloan Kettering Monmouth (Limited Protocol Activities) in Middletown, Memorial Sloan Kettering Bergen in Montvale, and Memorial Sloan Kettering Westchester (Limited Protocol Activities) in Harrison."
Answered by AI
What is the government organization's opinion of Atezolizumab?
"Atezolizumab has undergone Phase 2 clinical trials, meaning that while there is some evidence of its safety, none exists for its efficacy. Our team at Power have given it a rating of 2."
Answered by AI
Can you tell me if Atezolizumab has been studied before?
"Atezolizumab was first researched in 1997 at City of Hope Comprehensive Cancer Center. So far, there have been 1686 completed trials on this medication. Furthermore, there are 1323 active studies, with a large concentration of these occurring near Middletown, New jersey."
Answered by AI
What is the projected scope of this clinical trial?
"Unfortunately, this particular clinical trial is no longer seeking participants. The study was first posted on 3/22/2017 but the most recent update occurred on 7/11/2022. However, there are many other trials that may be of interest; at the moment, 230 trials involving patients with unresectable and 1323 Atezolizumab trials are admitting new participants."
Answered by AI
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