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Alkylating agents
Chemoradiotherapy + Atezolizumab for Bladder Cancer
Phase 3
Recruiting
Led By Parminder Singh
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
Patients who are known to be positive for human immunodeficiency virus (HIV) are eligible only if they have a stable regimen of highly active anti-retroviral therapy (HAART), no requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections, a CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR-based tests within 28 days prior to randomization
Patients must have Zubrod performance status =< 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer.
Who is the study for?
Adults with localized muscle invasive bladder cancer who've had a recent tumor removal and imaging, can participate. They must not have small cell carcinoma or certain other cancers in the last 24 months, no prior pelvic radiation or systemic chemotherapy for bladder cancer, and no severe liver disease or active infections. HIV-positive patients on stable treatment are eligible.Check my eligibility
What is being tested?
The trial is testing if adding Atezolizumab (an immunotherapy drug) to standard chemoradiotherapy (using drugs like gemcitabine, cisplatin) improves outcomes in bladder cancer treatment. Patients will be randomly assigned to receive either the combination of treatments or just chemoradiotherapy.See study design
What are the potential side effects?
Atezolizumab may cause immune-related reactions affecting organs, infusion reactions, fatigue; chemotherapy can lead to nausea, hair loss, blood disorders; radiation might result in skin irritation and fatigue. Side effects vary by individual.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am HIV positive, on stable HIV treatment, with no current infections, a CD4 count over 250, and an undetectable viral load.
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I can take care of myself but might not be able to do heavy physical work.
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I have mixed urothelial carcinoma but not small cell carcinoma.
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My bladder cancer is confirmed and untreated since diagnosis.
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I plan to follow a specific chemotherapy plan outlined in the study.
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I am 18 years old or older.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Bladder intact event-free survival (BI-EFS)
Secondary outcome measures
Biopsy response
Cancer-specific survival
Complete response duration
+5 moreOther outcome measures
Treatment interactions
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (RT, chemotherapy, atezolizumab)Experimental Treatment13 Interventions
Patients undergo RT (3DCRT or IMRT) daily Monday-Friday for up to 7-8 weeks and receive chemotherapy based on physician's choice as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo a TURBT with bladder biopsy at randomization and week 18 as well as cystoscopy at randomization, at weeks 18, 30, 42, 54, then every 3 months through year 2, followed by every 6months through year 5 and CT or MRI at randomization, at weeks 18, 30, 42, 54, then every 6 months through year 2, followed by every 12 months through year 5.
Group II: Arm I (RT, chemotherapy)Active Control12 Interventions
Patients undergo RT (3DCRT or IMRT) daily Monday-Friday for up to 7-8 weeks. Patients also receive chemotherapy based on physician's choice of gemcitabine IV twice weekly for 6 weeks concurrent with RT, or cisplatin IV weekly for 6 weeks concurrent with RT, or fluorouracil IV on same days as doses 1-5 and 16-20 of radiation therapy and mitomycin IV on day 1 of radiation therapy in the absence of disease progression or unacceptable toxicity. Patients also undergo a TURBT with bladder biopsy at randomization and week 18 as well as cystoscopy at randomization, at weeks 18, 30, 42, 54, then every 3 months through year 2, followed by every 6months through year 5 and CT or MRI at randomization, at weeks 18, 30, 42, 54, then every 6 months through year 2, followed by every 12 months through year 5.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Atezolizumab
2017
Completed Phase 3
~5860
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Cystoscopy
2016
Completed Phase 4
~810
Gemcitabine
2017
Completed Phase 3
~2070
Fluorouracil
2014
Completed Phase 3
~11540
Mitomycin
2009
Completed Phase 3
~410
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,663 Previous Clinical Trials
40,925,430 Total Patients Enrolled
Parminder SinghPrincipal InvestigatorSWOG Cancer Research Network
1 Previous Clinical Trials
2 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery in the last 28 days.I have not had a live vaccine in the last 4 weeks and won't need one during or up to 5 months after treatment.I haven't needed treatment for an autoimmune disease in the last two years.I may or may not be a candidate for bladder removal surgery.I am HIV positive, on stable HIV treatment, with no current infections, a CD4 count over 250, and an undetectable viral load.I had a bladder tumor removal surgery within the last 70 days.I have swelling in one kidney but my kidney function is still okay.I can complete health surveys in English or Spanish and agree to do so as required.You need to have an ECG test done within 30 days before joining the study.I haven't taken antibiotics for an infection in the last 14 days.My liver is healthy enough for cancer treatment.I am able to bear children, have taken a pregnancy test, and agree to use birth control.I have never had lung conditions like pulmonary fibrosis or pneumonitis.I can take care of myself but might not be able to do heavy physical work.I have not had treatment for my current bladder cancer.I am eligible for bladder removal but prefer a treatment that does not involve surgery.My bladder cancer is confirmed and untreated since diagnosis.I haven't taken any immune-weakening drugs in the last 14 days.I plan to follow a specific chemotherapy plan outlined in the study.I had hepatitis B in the past, but it's resolved now.I have mixed urothelial carcinoma but not small cell carcinoma.All side effects from my previous surgery or bladder treatments have mostly gone away.I have not had any drug treatments for my early-stage bladder cancer.You should not have widespread CIS based on a cystoscopy and biopsy.I have not had chemotherapy for my bladder cancer.I have never received radiation therapy to my pelvic area.I've had a biopsy of my enlarged lymph node, showing no cancer, within the last 70 days.I have hepatitis C antibodies but no active virus according to a PCR test.I have not had a bone marrow or organ transplant.I have never had active tuberculosis.I have not had any other cancer types, except for certain exceptions.I am 18 years old or older.I haven't had bladder cancer or related types outside the bladder in the last 2 years, except for specific early-stage cancers treated with complete surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (RT, chemotherapy, atezolizumab)
- Group 2: Arm I (RT, chemotherapy)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Has the FDA cleared Transurethral Resection of Bladder Tumor for patient use?
"There is some clinical data that suggests Transurethral Resection of Bladder Tumor is effective, and multiple rounds of data have been collected to support its safety, so it received a score of 3."
Answered by AI
What is the main reason that Transurethral Resection of Bladder Tumor is used?
"Transurethral Resection of Bladder Tumor is a common treatment for actinic keratosis. This medical procedure can also be used to effectively treat other conditions such as anal cancer, metastatic ureter urothelial carcinoma, and bladder cancer."
Answered by AI
How many people are being given the opportunity to partake in this research?
"In total, 475 volunteers are needed to complete this study. Those who meet the prerequisites can participate at Ascension All Saints Hospital in Racine, Wisconsin or Elmhurst Memorial Hospital in Elmhurst, Illinois."
Answered by AI
Could you tell us about other times Transurethral Resection of Bladder Tumor has been studied?
"There are currently 1624 active clinical trials investigating Transurethral Resection of Bladder Tumor (TURBT), with 489 trials in Phase 3. Shanghai, China is home to several of these studies, but TURBT trials are taking place at 80261 locations worldwide."
Answered by AI
Are individuals currently being enrolled in this experiment?
"This trial, which was first posted on 2019-04-19 and was last edited on 2022-11-03, is currently searching for candidates."
Answered by AI
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