Phase III Randomized Trial of Concurrent Chemoradiotherapy With or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer

Who is this study for? Adult patients with Localized Muscle Invasive Bladder Cancer
What treatments are being studied? Atezolizumab
Status: Active_not_recruiting
Location: See all (366) locations...
Intervention Type: Other, Procedure, Drug, Radiation
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This phase III trial studies how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as gemcitabine, cisplatin, fluorouracil and mitomycin-C, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving atezolizumab with radiation therapy and chemotherapy may work better in treating patients with localized muscle invasive bladder cancer compared to radiation therapy and chemotherapy without atezolizumab.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• STEP 1 REGISTRATION: If this will be the first patient from a registering site to receive a given RT modality (3DCRT vs. IMRT), the site must first submit pre-RT planning documents within 3 days of Step 1 registration and receive approval from Imaging and Radiation Oncology Core (IROC) before randomizing the patient to Step 2. If this will not be the first patient to receive a specific RT modality, the patient should be immediately randomized to Step 2 on the same day.

• STEP 2 RANDOMIZATION: If patient required review of pre-RT planning, randomization must occur within 14 days of initial registration.

• Patients must have histologically proven, T2-T4a N0M0 urothelial carcinoma of the bladder within 120 days prior to randomization and no intervening treatment between the histologic proof and randomization. Patients with mixed urothelial carcinoma will be eligible for the trial, but the presence of small cell carcinoma will make a patient ineligible. Patients with lymph nodes \>= 1.0 cm in shortest cross-sectional diameter on imaging (computed tomography \[CT\]/magnetic resonance imaging \[MRI\] of abdomen and pelvis) must have a biopsy of the enlarged lymph node showing no tumor involvement within 70 days prior to randomization. These patients may be suitable for neoadjuvant chemotherapy and radical cystectomy and are eligible for this trial if they seek out a bladder sparing treatment strategy, however patients who have received prior systemic chemotherapy for bladder cancer are not eligible for the trial.

• Patients must undergo a transurethral resection of bladder tumor (TURBT) within 70 days prior to randomization. In a situation where a patient is referred from outside to the enrolling institution, patient must have a repeat office cystoscopy by the urologist who will be following the patient on the clinical trial to assess the adequacy of the prior TURBT. This cystoscopy can be performed in urologist office without general anesthesia. Patient may then undergo repeat TURBT if deemed necessary as standard of care by the treating urologist. Patients may have either completely or partially resected tumors as long as the treating urologist attempted maximal resection. Patient must not have T4b disease

• Patients must undergo radiological staging within 70 days prior to randomization. Imaging of chest, abdomen, and pelvis must be performed using CT or MRI. Patients must not have evidence of T4bN1-3 disease. Eligibility is based on the local radiology report.

• Patients with hydronephrosis are eligible if they have unilateral hydronephrosis and kidney function meets criteria specified.

• Patients must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder within the previous 24 months except Ta/T1/carcinoma in situ (CIS) of the upper urinary tract including renal pelvis and ureter if the patient had undergone complete nephroureterectomy.

• Patients must not have diffuse CIS based on cystoscopy and biopsy.

• Patient must be planning to receive one of the protocol specified chemotherapy regimens.

• All adverse events associated with any prior surgery and intravesical therapy must have resolved to Common Terminology Criteria for Adverse Events (CTCAE) grade =\< 2 prior to randomization.

• Patient must not have received any systemic chemotherapy for their bladder cancer.

• Patient must not have had prior pelvic radiation.

• Patients must not have received prior treatment for muscle invasive bladder cancer including neoadjuvant chemotherapy for the current tumor.

• Patients must not have received any systemic therapy (including, but not limited to, interferon alfa-2b, high dose IL-2, pegylated interferon \[PEG-IFN\], anti-PD-1, anti-PD-L1), for non-muscle invasive bladder cancer. Prior intravesical bacillus Calmette-Guerin (BCG), interferon, and intravesical chemotherapy are allowed.

• Patients must not have received any of the following prohibited therapies within 28 days prior to randomization or be planning to receive any of the following prohibited therapies during protocol treatment:

‣ Anti-cancer systemic chemotherapy or biological therapy not specified in the protocol.

⁃ Immunotherapy not specified in this protocol.

⁃ Systemic or intravesical use of any non-study anti-cancer agent (investigational or non-investigational).

⁃ Investigational agents other than atezolizumab.

⁃ Live vaccines: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, BCG, and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. Flu-Mist®) are live attenuated vaccines, and are not allowed. Prior administration of intravesical BCG is allowed.

⁃ Glucocorticoids for any purpose other than to modulate symptoms from an event of suspected immunologic etiology. The use of physiologic doses of corticosteroids (defined as 10 mg prednisone) are acceptable, however site investigators should consult with the study chair for any dose higher than 10 mg prednisone. Dexamethasone 4 mg IV with chemotherapy to prevent nausea is allowed.

⁃ RANKL infusion: Concurrent denosumab (which binds the cytokine RANKL) for any known indication is prohibited due to interaction with study medication.

• Patients must not have a major surgical procedure within 28 days prior to randomization. If patient had any surgical procedure then they should have recovered to full presurgical performance status and surgical adverse events should have resolved to grade =\< 2. TURBT is not considered a major surgical procedure.

• Patients must not have received treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] agents) within 14 days prior to randomization. Exceptions:

‣ Patients may have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea).

⁃ The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed. Physiological doses equivalent of 10 mg prednisone daily are allowed. Short term steroids given as antiemetic therapy, e.g. 4 mg dexamethasone or equivalent once a week, is allowed.

• Patients must not have received a live, attenuated vaccine within 4 weeks prior to randomization or anticipate that such a live, attenuated vaccine will be required while on protocol treatment and up to 5 months after the last dose of protocol treatment.

‣ Inactivated influenza vaccination should be given during influenza season only (approximately October to March). Patients must not receive live, attenuated influenza vaccine within 4 weeks prior to randomization or while on protocol treatment and up to 5 months after the last dose of protocol treatment.

• Patients must not have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation.

• Patients must be \>= 18 years of age

• Patient may or may not be radical cystectomy candidates.

• Absolute neutrophil count (ANC) \>= 1,500/microliter (mcL) (within 28 days prior to randomization).

• Platelets \>= 100,000/mcL (within 28 days prior to randomization).

• Hemoglobin \>= 9 g/dL (within 28 days prior to randomization).

• Total bilirubin =\< 1.5 x institutional upper limit of normal (IULN) (except patients with Gilbert's syndrome, who must have a total bilirubin \< 3.0 mg/dL) (within 28 days prior to randomization).

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 2.5 x IULN (within 28 days prior to randomization).

• Patients must not have clinically significant liver disease that precludes patient from treatment regimens prescribed on the study (including, but not limited to, active viral, alcoholic or other autoimmune hepatitis, cirrhosis or inherited liver disease).

• Patients must have adequate renal function as evidenced by calculated creatinine clearance \>= 25 mL/min. The creatinine used to calculate the clearance result must have been obtained within 28 days prior to randomization.

• Patients must have Zubrod performance status =\< 2.

• Patients must have a baseline electrocardiography (ECG) performed within 30 days prior to randomization.

• Patient must not have history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis.

• Patients must not have an active infection requiring oral or IV antibiotics within 14 days prior to randomization. Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are not eligible. If patient develops urinary tract infection after TURBT they must have recovered from the infection prior to registration.

• Patients must not have active autoimmune disease that has required systemic treatment in past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Autoimmune diseases include, but are not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, Graves' disease treated with methimazole or glomerulonephritis.

• Patient must not have a history of active tuberculosis.

• If patient has a known history of hepatitis B virus (HBV) or hepatitis C virus (HCV), they must meet the following criteria within 28 days prior to randomization.

‣ Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen \[HBsAg\] test and a positive anti-HBc \[antibody to hepatitis B core antigen\] antibody test) are eligible.

⁃ Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA).

• Patients who are known to be positive for human immunodeficiency virus (HIV) are eligible only if they have all of the following:

‣ 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.

• No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for two years. Patients with localized prostate cancer who are being followed by an active surveillance program are also eligible.

• Female patients of childbearing potential must have a serum pregnancy test prior to randomization. Patients must not be pregnant or nursing due to the potential teratogenic side effects of the protocol treatment. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of protocol treatment, and for 5 months (150 days) after the last dose of all study drugs. A woman is considered to be of reproductive potential if she has had a menses at any time in the preceding 12 consecutive months.

• Patients must not be known to be allergic to Chinese hamster egg or ovary cell products and must not have any known major allergic reactions to any study drug.

• Patients must be offered the opportunity to participate in specimen banking for future studies.

• Patients who can complete Patient-Reported Outcome instruments in English or Spanish must agree to complete the EORTC QLQ-C30, the EORTC QLQ-BLM30, the EPIC Bowel Assessment, and the EQ-5D-5L per protocol schedule of assessment.

• As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.

Locations
United States
Arizona
Mayo Clinic Hospital in Arizona
Phoenix
Mayo Clinic in Arizona
Scottsdale
Banner University Medical Center - Tucson
Tucson
University of Arizona Cancer Center-North Campus
Tucson
California
Sutter Auburn Faith Hospital
Auburn
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn
Alta Bates Summit Medical Center-Herrick Campus
Berkeley
Mercy Cancer Center - Carmichael
Carmichael
Mercy San Juan Medical Center
Carmichael
Mercy Cancer Center - Elk Grove
Elk Grove
UC San Diego Moores Cancer Center
La Jolla
Cedars Sinai Medical Center
Los Angeles
Los Angeles General Medical Center
Los Angeles
USC / Norris Comprehensive Cancer Center
Los Angeles
Fremont - Rideout Cancer Center
Marysville
Memorial Medical Center
Modesto
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange
Palo Alto Medical Foundation Health Care
Palo Alto
Mercy Cancer Center - Rocklin
Rocklin
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville
Sutter Roseville Medical Center
Roseville
Mercy Cancer Center - Sacramento
Sacramento
Sutter Medical Center Sacramento
Sacramento
University of California Davis Comprehensive Cancer Center
Sacramento
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale
Woodland Memorial Hospital
Woodland
Colorado
UCHealth University of Colorado Hospital
Aurora
Rocky Mountain Cancer Centers-Boulder
Boulder
Memorial Hospital North
Colorado Springs
UCHealth Memorial Hospital Central
Colorado Springs
Shaw Cancer Center
Edwards
Cancer Care and Hematology-Fort Collins
Fort Collins
Poudre Valley Hospital
Fort Collins
Banner North Colorado Medical Center
Greeley
UCHealth Greeley Hospital
Greeley
Banner North Colorado Medical Center - Loveland Campus
Loveland
Medical Center of the Rockies
Loveland
Connecticut
Smilow Cancer Hospital Care Center at Greenwich
Greenwich
Smilow Cancer Hospital Care Center - Guilford
Guilford
Hartford Hospital
Hartford
Midstate Medical Center
Meriden
The Hospital of Central Connecticut
New Britain
Yale University
New Haven
Yale-New Haven Hospital North Haven Medical Center
North Haven
Smilow Cancer Hospital Care Center-Trumbull
Trumbull
Smilow Cancer Hospital Care Center - Waterford
Waterford
Washington, D.c.
Sibley Memorial Hospital
Washington D.c.
Delaware
Beebe South Coastal Health Campus
Millville
Helen F Graham Cancer Center
Newark
Medical Oncology Hematology Consultants PA
Newark
Beebe Health Campus
Rehoboth Beach
Florida
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach
UF Health Cancer Institute - Gainesville
Gainesville
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami
Mount Sinai Medical Center
Miami Beach
Sarasota Memorial Hospital-Venice
N. Venice
First Physicians Group - Urology Robotic and Minimally Invasive Surgery
Sarasota
Florida Cancer Specialists - Sarasota
Sarasota
Florida Cancer Specialists - Sarasota Downtown
Sarasota
Sarasota Memorial Health Care Center at University Parkway
Sarasota
Sarasota Memorial Hospital
Sarasota
Moffitt Cancer Center
Tampa
Georgia
Emory Saint Joseph's Hospital
Atlanta
Emory University Hospital Midtown
Atlanta
Emory University Hospital/Winship Cancer Institute
Atlanta
CTCA at Southeastern Regional Medical Center
Newnan
Hawaii
Hawaii Cancer Care - Westridge
‘aiea
Pali Momi Medical Center
‘aiea
The Cancer Center of Hawaii-Pali Momi
‘aiea
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu
Queen's Cancer Cenrer - POB I
Honolulu
Queen's Cancer Center - Kuakini
Honolulu
Queen's Medical Center
Honolulu
Straub Clinic and Hospital
Honolulu
The Cancer Center of Hawaii-Liliha
Honolulu
Iowa
Mary Greeley Medical Center
Ames
McFarland Clinic - Ames
Ames
Mercy Cancer Center-West Lakes
Clive
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive
Greater Regional Medical Center
Creston
Iowa Methodist Medical Center
Des Moines
Mercy Medical Center - Des Moines
Des Moines
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines
Mercy Medical Center-West Lakes
West Des Moines
Illinois
Advocate Good Shepherd Hospital
Barrington
Illinois CancerCare-Bloomington
Bloomington
Illinois CancerCare-Canton
Canton
Illinois CancerCare-Carthage
Carthage
Advocate Illinois Masonic Medical Center
Chicago
Northwestern University
Chicago
Rush MD Anderson Cancer Center
Chicago
AMG Crystal Lake - Oncology
Crystal Lake
Decatur Memorial Hospital
Decatur
Northwestern Medicine Cancer Center Kishwaukee
Dekalb
Advocate Good Samaritan Hospital
Downers Grove
Crossroads Cancer Center
Effingham
Advocate Sherman Hospital
Elgin
Elmhurst Memorial Hospital
Elmhurst
Illinois CancerCare-Eureka
Eureka
NorthShore University HealthSystem-Evanston Hospital
Evanston
Illinois CancerCare-Galesburg
Galesburg
Western Illinois Cancer Treatment Center
Galesburg
Northwestern Medicine Cancer Center Delnor
Geneva
NorthShore University HealthSystem-Glenbrook Hospital
Glenview
Advocate South Suburban Hospital
Hazel Crest
NorthShore University HealthSystem-Highland Park Hospital
Highland Park
Edward Hines Jr VA Hospital
Hines
Illinois CancerCare-Kewanee Clinic
Kewanee
AMG Libertyville - Oncology
Libertyville
Condell Memorial Hospital
Libertyville
Illinois CancerCare-Macomb
Macomb
Loyola University Medical Center
Maywood
Edward Hospital/Cancer Center
Naperville
Advocate Christ Medical Center
Oak Lawn
Illinois CancerCare-Ottawa Clinic
Ottawa
Advocate Lutheran General Hospital
Park Ridge
Illinois CancerCare-Pekin
Pekin
Illinois CancerCare-Peoria
Peoria
Methodist Medical Center of Illinois
Peoria
OSF Saint Francis Medical Center
Peoria
Illinois CancerCare-Peru
Peru
Illinois CancerCare-Princeton
Princeton
Springfield Clinic
Springfield
Springfield Memorial Hospital
Springfield
Carle Cancer Center
Urbana
Northwestern Medicine Cancer Center Warrenville
Warrenville
Illinois CancerCare - Washington
Washington
Indiana
Community Cancer Center East
Indianapolis
Community Cancer Center North
Indianapolis
Community Cancer Center South
Indianapolis
Reid Health
Richmond
Kansas
University of Kansas Cancer Center
Kansas City
University of Kansas Cancer Center-Overland Park
Overland Park
University of Kansas Hospital-Westwood Cancer Center
Westwood
Ascension Via Christi Hospitals Wichita
Wichita
Kentucky
Baptist Health Lexington
Lexington
University of Kentucky/Markey Cancer Center
Lexington
Baptist Health Louisville
Louisville
The James Graham Brown Cancer Center at University of Louisville
Louisville
Louisiana
Louisiana Hematology Oncology Associates LLC
Baton Rouge
Mary Bird Perkins Cancer Center
Baton Rouge
East Jefferson General Hospital
Metairie
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie
University Medical Center New Orleans
New Orleans
Massachusetts
Dana-Farber Cancer Institute
Boston
Massachusetts General Hospital Cancer Center
Boston
Lowell General Hospital
Lowell
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore
Maine
MaineHealth Coastal Cancer Treatment Center
Bath
MaineHealth Waldo Hospital
Belfast
MaineHealth Maine Medical Center - Biddeford
Biddeford
MaineHealth Stephens Hospital
Norway
MaineHealth Maine Medical Center - Portland
Portland
Penobscot Bay Medical Center
Rockport
MaineHealth Cancer Care and IV Therapy - Sanford
Sanford
MaineHealth Cancer Care Center of York County
Sanford
MaineHealth Maine Medical Center- Scarborough
Scarborough
MaineHealth Cancer Care and IV Therapy - South Portland
South Portland
Michigan
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor
University of Michigan Comprehensive Cancer Center
Ann Arbor
Bronson Battle Creek
Battle Creek
Trinity Health Medical Center - Brighton
Brighton
University of Michigan - Brighton Center for Specialty Care
Brighton
Trinity Health Medical Center - Canton
Canton
Chelsea Hospital
Chelsea
Michigan Healthcare Professionals Clarkston
Clarkston
Corewell Health Dearborn Hospital
Dearborn
Henry Ford Health Saint John Hospital
Detroit
Henry Ford Hospital
Detroit
Wayne State University/Karmanos Cancer Institute
Detroit
Corewell Health Farmington Hills Hospital
Farmington Hills
Michigan Healthcare Professionals Farmington
Farmington Hills
Weisberg Cancer Treatment Center
Farmington Hills
West Michigan Cancer Center
Kalamazoo
University of Michigan Health - Sparrow Lansing
Lansing
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia
Henry Ford Saint John Hospital - Macomb Medical
Macomb
Michigan Healthcare Professionals Madison Heights
Madison Heights
Michigan Healthcare Professionals Pontiac
Pontiac
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac
Corewell Health William Beaumont University Hospital
Royal Oak
MyMichigan Medical Center Saginaw
Saginaw
Munson Medical Center
Traverse City
Corewell Health Beaumont Troy Hospital
Troy
Michigan Healthcare Professionals Troy
Troy
Henry Ford Health Warren Hospital
Warren
Henry Ford West Bloomfield Hospital
West Bloomfield
University of Michigan Health - West
Wyoming
Minnesota
Sanford Joe Lueken Cancer Center
Bemidji
Mercy Hospital
Coon Rapids
Miller-Dwan Hospital
Duluth
Fairview Southdale Hospital
Edina
Unity Hospital
Fridley
Monticello Cancer Center
Monticello
Mayo Clinic in Rochester
Rochester
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park
Regions Hospital
Saint Paul
Missouri
Parkland Health Center-Bonne Terre
Bonne Terre
Saint Francis Medical Center
Cape Girardeau
Siteman Cancer Center at Saint Peters Hospital
City Of Saint Peters
Siteman Cancer Center at West County Hospital
Creve Coeur
University of Kansas Cancer Center - North
Kansas City
University of Kansas Cancer Center - Lee's Summit
Lee's Summit
Heartland Regional Medical Center
Saint Joseph
Sainte Genevieve County Memorial Hospital
Sainte Genevieve
CoxHealth South Hospital
Springfield
Mercy Hospital Saint Louis
St Louis
Mercy Hospital South
St Louis
Missouri Baptist Medical Center
St Louis
Siteman Cancer Center-South County
St Louis
Washington University School of Medicine
St Louis
Missouri Baptist Sullivan Hospital
Sullivan
BJC Outpatient Center at Sunset Hills
Sunset Hills
Montana
Billings Clinic Cancer Center
Billings
Bozeman Health Deaconess Hospital
Bozeman
Benefis Sletten Cancer Institute
Great Falls
North Carolina
Margaret R Pardee Memorial Hospital
Hendersonville
ECU Health Oncology Kenansville
Kenansville
ECU Health Oncology Kinston
Kinston
ECU Health Oncology Richlands
Richlands
North Dakota
Sanford Bismarck Medical Center
Bismarck
Sanford Broadway Medical Center
Fargo
Sanford Roger Maris Cancer Center
Fargo
Nebraska
Nebraska Medicine-Bellevue
Bellevue
CHI Health Good Samaritan
Kearney
Nebraska Medicine-Village Pointe
Omaha
Nebraska Methodist Hospital
Omaha
University of Nebraska Medical Center
Omaha
New Hampshire
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon
New Jersey
Memorial Sloan Kettering Basking Ridge
Basking Ridge
Cooper Hospital University Medical Center
Camden
Hackensack University Medical Center
Hackensack
Memorial Sloan Kettering Monmouth
Middletown
Memorial Sloan Kettering Bergen
Montvale
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees Township
Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas
OptumCare Cancer Care at Charleston
Las Vegas
OptumCare Cancer Care at Fort Apache
Las Vegas
Radiation Oncology Centers of Nevada Central
Las Vegas
Radiation Oncology Centers of Nevada Southeast
Las Vegas
Renown Regional Medical Center
Reno
New York
Memorial Sloan Kettering Commack
Commack
Memorial Sloan Kettering Westchester
Harrison
Northwell Health/Center for Advanced Medicine
Lake Success
Memorial Sloan Kettering Cancer Center
New York
Highland Hospital
Rochester
University of Rochester
Rochester
Phelps Memorial Hospital Center
Sleepy Hollow
Stony Brook University Medical Center
Stony Brook
State University of New York Upstate Medical University
Syracuse
Montefiore Medical Center - Moses Campus
The Bronx
Montefiore Medical Center-Einstein Campus
The Bronx
Montefiore Medical Center-Weiler Hospital
The Bronx
Memorial Sloan Kettering Nassau
Uniondale
Good Samaritan University Hospital
West Islip
Ohio
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati
MetroHealth Medical Center
Cleveland
Ohio State University Comprehensive Cancer Center
Columbus
Dayton Physician LLC - Englewood
Dayton
Greater Dayton Cancer Center
Kettering
Kettering Medical Center
Kettering
University of Cincinnati Cancer Center-West Chester
West Chester
Oklahoma
Cancer Centers of Southwest Oklahoma Research
Lawton
Mercy Hospital Oklahoma City
Oklahoma City
University of Oklahoma Health Sciences Center
Oklahoma City
Oregon
Oregon Health and Science University
Portland
Pennsylvania
Lehigh Valley Hospital-Cedar Crest
Allentown
UPMC Altoona
Altoona
UPMC-Heritage Valley Health System Beaver
Beaver
Lehigh Valley Hospital - Muhlenberg
Bethlehem
Carlisle Regional Cancer Center
Carlisle
Christiana Care Health System-Concord Health Center
Chadds Ford
Geisinger Medical Center
Danville
UPMC Hillman Cancer Center Erie
Erie
UPMC Cancer Center at UPMC Horizon
Farrell
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg
Penn State Milton S Hershey Medical Center
Hershey
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown
Geisinger Medical Oncology-Lewisburg
Lewisburg
UPMC Cancer Center at UPMC McKeesport
Mckeesport
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg
UPMC Cancer Center - Monroeville
Monroeville
UPMC Hillman Cancer Center in Coraopolis
Moon Township
Arnold Palmer Cancer Center Medical Oncology Norwin
N. Huntingdon
UPMC Hillman Cancer Center - New Castle
New Castle
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh
UPMC-Magee Womens Hospital
Pittsburgh
UPMC-Passavant Hospital
Pittsburgh
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh
UPMC-Saint Margaret
Pittsburgh
UPMC-Shadyside Hospital
Pittsburgh
UPMC Cancer Center at UPMC Northwest
Seneca
UPMC Uniontown Hospital Radiation Oncology
Uniontown
UPMC Washington Hospital Radiation Oncology
Washington
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-barre
UPMC Memorial
York
South Carolina
Medical University of South Carolina
Charleston
Prisma Health Cancer Institute - Eastside
Greenville
Prisma Health Cancer Institute - Faris
Greenville
Gibbs Cancer Center-Pelham
Greer
Prisma Health Cancer Institute - Greer
Greer
Carolina Regional Cancer Center
Myrtle Beach
Spartanburg Medical Center
Spartanburg
South Dakota
Sanford Cancer Center Oncology Clinic
Sioux Falls
Sanford USD Medical Center - Sioux Falls
Sioux Falls
Tennessee
Vanderbilt University/Ingram Cancer Center
Nashville
Texas
UT Southwestern/Simmons Cancer Center-Dallas
Dallas
University of Texas Medical Branch
Galveston
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston
Michael E DeBakey VA Medical Center
Houston
UT Southwestern Clinical Center at Richardson/Plano
Richardson
Virginia
Augusta Health Center for Cancer and Blood Disorders
Fishersville
Vermont
Dartmouth Cancer Center - North
Saint Johnsbury
Washington
MultiCare Auburn Medical Center
Auburn
MultiCare Gig Harbor Medical Park
Gig Harbor
FHCC at EvergreenHealth
Kirkland
MultiCare Good Samaritan Hospital
Puyallup
Valley Medical Center
Renton
Fred Hutchinson Cancer Center
Seattle
University of Washington Medical Center - Montlake
Seattle
Saint Michael Cancer Center
Silverdale
MultiCare Tacoma General Hospital
Tacoma
Wisconsin
Langlade Hospital and Cancer Center
Antigo
Ascension Saint Elizabeth Hospital
Appleton
Northwest Wisconsin Cancer Center
Ashland
Aurora Cancer Care-Southern Lakes VLCC
Burlington
Marshfield Medical Center-EC Cancer Center
Eau Claire
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire
Aurora Health Care Germantown Health Center
Germantown
Aurora Cancer Care-Grafton
Grafton
Aurora BayCare Medical Center
Green Bay
Bellin Memorial Hospital
Green Bay
Aurora Cancer Care-Kenosha South
Kenosha
Mayo Clinic Health System-Franciscan Healthcare
La Crosse
Aurora Bay Area Medical Group-Marinette
Marinette
Marshfield Medical Center-Marshfield
Marshfield
Aspirus Medford Hospital
Medford
Aurora Cancer Care-Milwaukee
Milwaukee
Aurora Saint Luke's Medical Center
Milwaukee
Aurora Sinai Medical Center
Milwaukee
Marshfield Medical Center - Minocqua
Minocqua
Cancer Center of Western Wisconsin
New Richmond
Ascension Mercy Hospital
Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh
Ascension All Saints Hospital
Racine
Aurora Cancer Care-Racine
Racine
Marshfield Medical Center-Rice Lake
Rice Lake
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan
Aspirus Cancer Care - Stevens Point
Stevens Point
Marshfield Medical Center-River Region at Stevens Point
Stevens Point
Aurora Medical Center in Summit
Summit
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers
Aspirus Regional Cancer Center
Wausau
Aurora Cancer Care-Milwaukee West
Wauwatosa
Aurora West Allis Medical Center
West Allis
Marshfield Medical Center - Weston
Weston
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids
West Virginia
West Virginia University Healthcare
Morgantown
Time Frame
Start Date: 2019-06-03
Completion Date: 2027-06-01
Participants
Target number of participants: 475
Treatments
Active_comparator: Arm I (RT, chemotherapy)
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.
Experimental: Arm II (RT, chemotherapy, atezolizumab)
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.
Authors
Stephen B. Williams, Kathleen J. Yost, Rubina Qamar, Daniel J. Krauss, Robert A. Somer, Jonathan S. Treisman, Jessica M. Clement, Hassan I. Tahsildar, Ralph J. Hauke, Scott E. Delacroix, Christopher M. George, Richard K. Valicenti, Robert S. Alter, Thomas J. Spillane, Bryan A. Faller, Li Zhang, Michael Humeniuk, Preston D. Steen, Yuhchyau Chen, Bruce J. Averbook, Howard M. Gross, Jay W. Carlson, Parminder Singh, Ramy F. Yaacoub, Donald J. Jurgens, Brian C. Myre, Brian C. Baumann, John M. Schallenkamp, Ellis G. Levine, Ding Wang, Marisa A. Kollmeier, John A. Ellerton, Austin N. Kirschner, Tareq Al Baghdadi, Frank A. Vicini, Alexander N. Slade, Suzanne M. Cole, Xinglei Shen, Patricia H. Hardenbergh, Matthew D. Cheney, Bamidele A. Adesunloye, Paul L. Crispen, Dian Wang, Elizabeth Henry, Joshua Lukenbill, Kent W. Mouw, Misbah U. Qadir, Vladimir Valakh, Theodore S. Gourdin, Nicholas DiBella, John A. Keech, Ki Y. Chung, Tyler Stewart, Michael J. Baine, Ami Badami, Debra M. Prow, Benjamin A. Gartrell, Joshua S. Weir, Jacqueline Vuky, Richard L. Jennelle, Shaker R. Dakhil, Leslie Ballas, Eric W. Dean, Elizabeth R. Kessler, Praveen Vashist, Peng Wang, Alan C. Hartford, Kelvin B. Raybon, Michael A. Ahdoot, Ashesh B. Jani, Bilal K. Siddiqui, Nitin G. Vaishampayan, David J. Tamura, Bevan Ly, Bret E. Friday, Phuoc T. Tran, Andrew J. Hart, Richard L. Deming, Aihua E. Yen, Edmund W. Tai, David M. King, Petros Grivas, Sean Sachdev, Abhinav Sidana, Haythem Y. Ali, Shreya Sinha, Jason A. Efstathiou, Monika Joshi, Thomas P. Bradley, George D. Grass, Samuel D. Kaffenberger, Uday C. Lele, Gregory A. Masters, Alina Basnet, Adam Olson, Harish G. Ahuja, Vikas K. Singh
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov