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Atezolizumab in Treating Patients With Recurrent BCG-Unresponsive Non-muscle Invasive Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02844816
Recruitment Status : Active, not recruiting
First Posted : July 26, 2016
Last Update Posted : October 4, 2019
Sponsor:
Collaborator:
Canadian Cancer Trials Group
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This phase II trial studies how well atezolizumab works in treating patients with non-muscle invasive bladder cancer that has come back and has not responded to treatment with Bacillus Calmette-Guerin (BCG). 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.

Condition or disease Intervention/treatment Phase
Recurrent Bladder Urothelial Carcinoma Stage 0a Bladder Urothelial Carcinoma AJCC v6 and v7 Stage 0is Bladder Urothelial Carcinoma AJCC v6 and v7 Stage I Bladder Urothelial Carcinoma AJCC v6 and v7 Drug: Atezolizumab Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To estimate complete response at 25 weeks after registration for those with a carcinoma in situ (CIS) component and to evaluate event-free survival at 18 months in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (Ta/T1/CIS) treated with atezolizumab.

SECONDARY OBJECTIVES:

I. To estimate event-free survival at 18 months for the subset of patients with papillary cancer (Ta/T1).

II. To estimate progression-free survival, cystectomy-free survival, bladder cancer-specific survival, overall survival in all patients.

ADDITIONAL OBJECTIVES:

I. To estimate the level of agreement between local and central pathology review in terms of recurrence (for all patients) and complete response (for the CIS subset).

II. To identify markers that predict response to atezolizumab in the CIS population and that are associated with event-free survival (EFS) in patients with Ta/T1/CIS BCG-unresponsive non-muscle invasive bladder cancer. The following markers will be tested:

IIIa. Expression of PD-L1 and CD8 by immunohistochemistry (IHC). IIIb. Expression of immune signatures by ribonucleic acid (RNA)-sequencing (RNA-seq).

IIIc. Peripheral immune response by mass cytometry (CyTOF) and TruCulture.

OUTLINE:

Patients receive atezolizumab intravenously (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.

After completion of study treatment, patients are followed up every 12 weeks for 2 years and then every 24 weeks for 3 years.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 202 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Atezolizumab in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Actual Study Start Date : February 7, 2017
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: Treatment (atezolizumab)
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.
Drug: Atezolizumab
Given IV
Other Names:
  • MPDL 3280A
  • MPDL 328OA
  • MPDL-3280A
  • MPDL3280A
  • MPDL328OA
  • RG7446
  • RO5541267
  • Tecentriq




Primary Outcome Measures :
  1. Complete response (CR) rate in the subset of patients with carcinoma in situ (CIS) based on biopsy [ Time Frame: At 25 weeks ]
    Will be estimated to within +/- 12% (95% confidence interval).

  2. Event-free survival (EFS) [ Time Frame: From date of registration to first documentation of event, assessed up to 18 months ]
    The 18-month EFS estimate will be obtained using the method of Kaplan and Meier, and the Greenwood formula will be used to estimate the variance. A 90% confidence interval will be estimated for the 18-month EFS estimate. The 99% confidence interval around the 18 month EFS Kaplan-Meier estimate will be constructed.


Secondary Outcome Measures :
  1. Event-free survival (EFS) in the Ta/T1 subset [ Time Frame: 18 months ]
    Will estimate for the subset of patients with papillary cancer (Ta/T1).

  2. Progression-free survival (PFS) [ Time Frame: From time of registration to time of first documentation progression or death due to any cause, assessed up to 5 years ]
    Progression will be defined as biopsy proven muscle invasive disease stage >= T2, nodal or distant metastasis and estimated using Kaplan-Meier.

  3. Cystectomy-free survival [ Time Frame: Up to 5 years ]
    Estimated using Kaplan-Meier.

  4. Bladder cancer specific survival [ Time Frame: From date of registration to date of death due to bladder cancer, assessed up to 5 years ]
    Estimated using Kaplan-Meier.

  5. Overall survival [ Time Frame: From date of registration to date of death due to any cause, assessed up to 5 years ]
    Estimated using Kaplan-Meier.

  6. Incidence of adverse events [ Time Frame: Up to 18 months ]
    Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Qualitative and quantitative toxicity assessment will be provided using CTCAE reporting. Will be estimated to within +/- 9% (95% confidence interval).


Other Outcome Measures:
  1. Recurrence in all patients [ Time Frame: Up to 5 years ]
    Will estimate the level of agreement between local and central pathology review.

  2. CR for the CIS subset [ Time Frame: Up to 5 years ]
    Will estimate the level of agreement between local and central pathology review.

  3. PD-L1 and CD8 expression [ Time Frame: Up to 5 years ]
    Logistic regression will be used to regress the dichotomous CR status of each CIS patient on the indicator of programmed cell death - ligand (PD-L)1 expression. Fisher's exact test may be used if the proportion of complete responders or proportion of patients expressing PD-L1 is small. Similarly, using all patients, logistic regression will also be used to regress dichotomous 18-month EFS status of each patient on the indicator PD-L1 expression. The analysis will be repeated with CD8 expression as well as other markers. The type I error rate will be controlled at the two-sided alpha=0.05.

  4. Immune signature expression [ Time Frame: Up to 5 years ]
    Logistic regression will be used to regress CR status for each CIS patient on an indicator for whether each patient expresses the signature. Similarly, to determine whether pre-defined signatures are predictive of 18-month EFS in all patients, logistic regression will be used to regress 18-month EFS status for each patient on an indicator for whether each patient expresses the signature. This analysis will be repeated for each signature considered. Investigators will again consider using Fisher's exact test if the CR or 18-month EFS rates or the proportion of patients expressing the signature are low. Type I error rate will be controlled at the 2-sided alpha=0.05 level.



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Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically proven, recurrent, non-muscle invasive urothelial carcinoma of the bladder within 60 days prior to registration; the carcinoma must be stage T1 high-grade, stage CIS, or stage Ta high-grade
  • Patients with mixed urothelial carcinoma and a glandular and/or squamous component will be eligible for the trial, but the presence of other histologic variants, pure adenocarcinoma, or pure squamous cell carcinoma, or pure squamous carcinoma in situ will make a patient ineligible
  • Patients must have had all visible tumor resected completely within 60 days prior to registration; CIS disease is not expected to be completely excised; all patients must have tumor tissue from the histologic diagnosis of recurrence available for central pathology review submission; failure to submit these materials will make the patient ineligible for this study
  • Patients must have had cystoscopy confirming no visible papillary tumor within 21 days prior to registration; (CIS disease is not expected to have been completely excised); if the transurethral resection of bladder tumor (TURBT) or bladder biopsy falls within 21 days of registration it will fulfill this criterion
  • Patients must have had urine cytology within 21 days prior to registration; cytology for patients with CIS component is not expected to be negative for malignant cells; if the cytology for male patients with only Ta/T1 disease in the absence of CIS is positive for malignant cells, patient must have had a biopsy of the prostatic urethra within the previous six months
  • All patients with T1 urothelial carcinoma at study entry must undergo re-TURBT within 60 days prior to registration, and must have evidence of uninvolved muscularis propria in the pathologic specimen from either the first or the second TURBT; tissue from the re-resection must be submitted for central review in addition to the tissue from the first TURBT; the TURBT that identified the recurrent T1 disease may have taken place more than 60 days prior to registration but not more than 120 days; patients with high grade Ta or CIS do not require a re-TURBT, but if this is performed at the discretion of the treating physician, the second TURBT must be within 60 days of registration; there is no requirement for muscularis propria in the specimen of Ta/CIS patients, but the tissue from the first and second TURBTs must be submitted for central review; if a patient with Ta/T1 disease undergoes repeat TURBT, the patient will be stratified as having CIS if there is CIS on either TURBT
  • Patients must not have had urothelial carcinoma in the prostatic urethra within the previous 24 months or muscle invasive urothelial carcinoma of the bladder at any time; patients with prior urothelial carcinoma in the upper urinary tract within the previous 24 months will only be eligible if they had =< T1 carcinoma and were treated with nephroureterectomy; patients must have a computed tomography (CT) or magnetic resonance imaging (MRI) (including CT-intravenous pyelogram [IVP], CT-urogram or MR-urogram) of the abdomen and pelvis to rule out upper tract malignancy and intra-abdominal metastases within 90 days prior to registration; if a patient cannot tolerate intravenous contrast, a retrograde pyelogram should be performed within 90 days prior to registration
  • Patients must be deemed unfit for radical cystectomy by the treating physician, or the patient must refuse radical cystectomy, which is considered standard of care for these patients; the reason for patients not to undergo cystectomy will be clearly documented
  • Patients must be BCG-unresponsive; a patient is BCG-unresponsive if they meet one or more of the following criteria:

    • Patient has persistent or recurrent high-grade Ta/CIS urothelial carcinoma after completing therapy with at least induction BCG (>= 5 doses) and first round maintenance (>= 2 doses) or second induction BCG (>= 2 doses); both rounds of BCG must have been administered within a 12 month period; these patients must have either had high-grade Ta tumors and did not achieve a disease-free state for more than 6 months following last dose of BCG, or they had CIS and did not achieve a CR; S1605 registration must occur within 9 months of the last dose of BCG

      • If a patient does not meet these criteria only because the last dose of BCG was more than 9 months ago, the patient may become eligible if he/she shows histologically proven high-grade recurrence after an additional round of induction or maintenance BCG (>= 3 doses) within 9 months prior to registration
    • Patient has persistent or recurrent high grade T1 urothelial carcinoma after completing therapy with at least induction BCG (>= 5 doses); patients with recurrent high grade T1 urothelial carcinoma after additional rounds of BCG will also be eligible, but one round of maintenance therapy or a second induction is not a pre-requisite for these patients. Trial registration must occur within 9 months of the last dose of BCG

      • If a patient does not meet these criteria only because the last dose of BCG was more than 9 months ago, the patient may become eligible if he/she shows histologically proven high grade recurrence after an additional round of induction or maintenance BCG (>= 3 doses) within 9 months prior to registration
    • Patient achieves disease-free state at 6 month time point (i.e., complete response; presence of only low-grade tumor at this timepoint is still considered complete response) after induction and maintenance (or second round of induction) BCG but later experiences a high-grade Ta/T1recurrence (with or without concomitant CIS) within 6 months after the last dose of BCG or recurrent CIS (in absence of concomitant Ta/T1 tumor) within 12 months after the last BCG dose; the time of eligibility is measured from the last dose of BCG to the time of disease recurrence; the patient must be registered on the trial within 60 days of this recurrence, or within 60 days of a re-TURBT if indicated
  • All adverse events associated with any prior surgery and intravesical therapy must have resolved to grade =< 2 prior to registration
  • Patients must not have had prior systemic chemotherapy for bladder cancer or systemic immunotherapy, including, but not limited to interferon alfa-2b, high dose interleukin 2 (IL-2), pegylated interferon (PEG-IFN), PD-1, anti-PD-L1, intra-tumoral; patients must not have had vaccine therapies within 6 weeks prior to registration; patients must not have received or be planning to receive any of the prohibited therapies during protocol treatment; prior intravesical administration of chemotherapy, interferon, Vicinium (VB4-485), BC-819 or Instiladrin (rAd-interferon-alpha/Syn3) is allowed if all other criteria are met and the last administration was >= 30 days before registration
  • 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 any prior radiation to the bladder for bladder cancer
  • 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 4 weeks prior to registration; exceptions: (1) patients may have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea); (2) the use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
  • 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

    • 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 cycle 1, day 1 or at any time during the study
  • Patients must not require treatment with a RANKL inhibitor (e.g. denosumab) who cannot discontinue it before treatment with atezolizumab
  • Absolute neutrophil count (ANC) >= 1,500 microliter (mcL) (within 42 days prior to registration)
  • Platelets >= 100,000/mcL (within 42 days prior to registration)
  • Hemoglobin >= 9 g/dL (within 42 days prior to registration)
  • Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dL) (within 42 days prior to registration)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2 x IULN (within 42 days prior to registration)
  • Serum creatinine =< 1.5 ULN OR measured or calculated creatinine clearance >= 30 mL/min (within 42 days prior to registration)
  • Patients must have Zubrod performance status =< 2
  • Patients must have a baseline electrocardiograph (ECG) performed within 42 days prior to registration
  • 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 registration; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible
  • Patients must not have severe infections within 28 days prior to registration, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
  • 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, or glomerulonephritis
  • Patients must not have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation
  • Patient must not have active tuberculosis
  • Patients must not have active hepatitis B (chronic or acute) or active hepatitis C infection

    • 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 RNA
  • Patients 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
  • 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 five years
  • Patients must not be pregnant or nursing due to the potential teratogenic side effects of the protocol treatment; administration of atezolizumab may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality; 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 study participation, and for 5 months (150 days) after the last dose of study agent; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  • Due to the potential drug reaction with atezolizumab, patients must not be known to be allergic to Chinese hamster egg or ovaries
  • Patients must be offered the opportunity to participate in specimen banking for future studies, to include translational medicine studies
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02844816


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Locations
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United States, Alabama
Southern Cancer Center PC-Daphne
Daphne, Alabama, United States, 36526
Southern Cancer Center PC-Mobile
Mobile, Alabama, United States, 36607
Southern Cancer Center PC-Providence
Mobile, Alabama, United States, 36608
Southern Cancer Center PC-Springhill
Mobile, Alabama, United States, 36608
United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona, United States, 85704
Banner University Medical Center - Tucson
Tucson, Arizona, United States, 85719
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States, 85719
United States, Arkansas
John L McClellan Memorial Veterans Hospital
Little Rock, Arkansas, United States, 72205
United States, California
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Los Angeles County-USC Medical Center
Los Angeles, California, United States, 90033
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States, 94304
Eisenhower Medical Center
Rancho Mirage, California, United States, 92270
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
UCSF Medical Center-Mission Bay
San Francisco, California, United States, 94158
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Kaiser Permanente-Franklin
Denver, Colorado, United States, 80205
Kaiser Permanente-Rock Creek
Lafayette, Colorado, United States, 80026
Kaiser Permanente-Lone Tree
Lone Tree, Colorado, United States, 80124
United States, Connecticut
Greenwich Hospital
Greenwich, Connecticut, United States, 06830
Yale University
New Haven, Connecticut, United States, 06520
Veterans Affairs Connecticut Healthcare System-West Haven Campus
West Haven, Connecticut, United States, 06516
United States, Delaware
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, United States, 19713
Helen F Graham Cancer Center
Newark, Delaware, United States, 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States, 19713
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States, 19801
United States, District of Columbia
MedStar Washington Hospital Center
Washington, District of Columbia, United States, 20010
George Washington University Medical Center
Washington, District of Columbia, United States, 20037
United States, Florida
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida, United States, 33180
University of Florida Health Science Center - Gainesville
Gainesville, Florida, United States, 32610
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Indian River Medical Center
Vero Beach, Florida, United States, 32960
United States, Georgia
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Atlanta VA Medical Center
Decatur, Georgia, United States, 30033
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States, 31405
United States, Hawaii
Pali Momi Medical Center
'Aiea, Hawaii, United States, 96701
Hawaii Cancer Care Inc-POB II
Honolulu, Hawaii, United States, 96813
Hawaii Oncology Inc-POB I
Honolulu, Hawaii, United States, 96813
Island Urology
Honolulu, Hawaii, United States, 96813
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Straub Clinic and Hospital
Honolulu, Hawaii, United States, 96813
University of Hawaii Cancer Center
Honolulu, Hawaii, United States, 96813
Hawaii Oncology Inc-Kuakini
Honolulu, Hawaii, United States, 96817
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States, 83706
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, United States, 83712
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, United States, 83605
Walter Knox Memorial Hospital
Emmett, Idaho, United States, 83617
Idaho Urologic Institute-Meridian
Meridian, Idaho, United States, 83642
Saint Luke's Mountain States Tumor Institute - Meridian
Meridian, Idaho, United States, 83642
Saint Alphonsus Medical Center-Nampa
Nampa, Idaho, United States, 83686
Saint Luke's Mountain States Tumor Institute-Twin Falls
Twin Falls, Idaho, United States, 83301
United States, Illinois
Rush - Copley Medical Center
Aurora, Illinois, United States, 60504
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States, 61704
Illinois CancerCare-Canton
Canton, Illinois, United States, 61520
Illinois CancerCare-Carthage
Carthage, Illinois, United States, 62321
Centralia Oncology Clinic
Centralia, Illinois, United States, 62801
Northwestern University
Chicago, Illinois, United States, 60611
Carle on Vermilion
Danville, Illinois, United States, 61832
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States, 62526
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Carle Physician Group-Effingham
Effingham, Illinois, United States, 62401
Crossroads Cancer Center
Effingham, Illinois, United States, 62401
Elmhurst Memorial Hospital
Elmhurst, Illinois, United States, 60126
Illinois CancerCare-Eureka
Eureka, Illinois, United States, 61530
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States, 61401
Edward Hines Jr VA Hospital
Hines, Illinois, United States, 60141
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States, 61443
Illinois CancerCare-Macomb
Macomb, Illinois, United States, 61455
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States, 62864
Edward Hospital/Cancer Center
Naperville, Illinois, United States, 60540
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Illinois CancerCare-Pekin
Pekin, Illinois, United States, 61554
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Illinois CancerCare-Peru
Peru, Illinois, United States, 61354
Edward Hospital/Cancer Center?Plainfield
Plainfield, Illinois, United States, 60585
Illinois CancerCare-Princeton
Princeton, Illinois, United States, 61356
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Springfield Clinic
Springfield, Illinois, United States, 62702
Memorial Medical Center
Springfield, Illinois, United States, 62781
Carle Cancer Center
Urbana, Illinois, United States, 61801
The Carle Foundation Hospital
Urbana, Illinois, United States, 61801
Rush-Copley Healthcare Center
Yorkville, Illinois, United States, 60560
United States, Indiana
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Community Cancer Center East
Indianapolis, Indiana, United States, 46219
Community Cancer Center South
Indianapolis, Indiana, United States, 46227
Community Cancer Center North
Indianapolis, Indiana, United States, 46256
Community Howard Regional Health
Kokomo, Indiana, United States, 46904
Reid Health
Richmond, Indiana, United States, 47374
United States, Kansas
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Hays Medical Center
Hays, Kansas, United States, 67601
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States, 67905
Cancer Center of Kansas-Manhattan
Manhattan, Kansas, United States, 66502
Cancer Center of Kansas - McPherson
McPherson, Kansas, United States, 67460
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Olathe Medical Center
Olathe, Kansas, United States, 66061
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States, 67357
Via Christi Hospital-Pittsburg
Pittsburg, Kansas, United States, 66762
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67401
Salina Regional Health Center
Salina, Kansas, United States, 67401
Saint Francis Hospital and Medical Center - Topeka
Topeka, Kansas, United States, 66606
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Kentucky
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
United States, Louisiana
East Jefferson General Hospital
Metairie, Louisiana, United States, 70006
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana, United States, 70006
Louisiana State University Health Science Center
New Orleans, Louisiana, United States, 70112
Louisiana State University Health Sciences Center Shreveport
Shreveport, Louisiana, United States, 71103
United States, Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Lowell General Hospital
Lowell, Massachusetts, United States, 01854
United States, Michigan
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106
IHA Hematology Oncology Consultants-Brighton
Brighton, Michigan, United States, 48114
Saint Joseph Mercy Brighton
Brighton, Michigan, United States, 48114
IHA Hematology Oncology Consultants-Canton
Canton, Michigan, United States, 48188
Saint Joseph Mercy Canton
Canton, Michigan, United States, 48188
Caro Cancer Center
Caro, Michigan, United States, 48723
IHA Hematology Oncology Consultants-Chelsea
Chelsea, Michigan, United States, 48118
Saint Joseph Mercy Chelsea
Chelsea, Michigan, United States, 48118
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, United States, 48346
Newland Medical Associates-Clarkston
Clarkston, Michigan, United States, 48346
Michigan State University Clinical Center
East Lansing, Michigan, United States, 48824-7016
Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan, United States, 48503
Genesee Hematology Oncology PC
Flint, Michigan, United States, 48503
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan, United States, 48453
Newland Medical Associates-Pontiac
Pontiac, Michigan, United States, 48341
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341
Ascension Saint Mary's Hospital
Saginaw, Michigan, United States, 48601
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, United States, 48604
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan, United States, 48661
Huron Gastroenterology PC
Ypsilanti, Michigan, United States, 48106
IHA Hematology Oncology Consultants-Ann Arbor
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Essentia Health - Deer River Clinic
Deer River, Minnesota, United States, 56636
Essentia Health Cancer Center
Duluth, Minnesota, United States, 55805
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, United States, 55805
Miller-Dwan Hospital
Duluth, Minnesota, United States, 55805
Saint Luke's Hospital of Duluth
Duluth, Minnesota, United States, 55805
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Essentia Health Hibbing Clinic
Hibbing, Minnesota, United States, 55746
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, United States, 56303
Saint Cloud Hospital
Saint Cloud, Minnesota, United States, 56303
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Essentia Health Virginia Clinic
Virginia, Minnesota, United States, 55792
Fairview Lakes Medical Center
Wyoming, Minnesota, United States, 55092
United States, Missouri
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, United States, 63628
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
Southeast Cancer Center
Cape Girardeau, Missouri, United States, 63703
University of Missouri - Ellis Fischel
Columbia, Missouri, United States, 65212
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, United States, 64128
Missouri Baptist Medical Center
Saint Louis, Missouri, United States, 63131
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, United States, 63670
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, United States, 63080
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri, United States, 63127
United States, Montana
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States, 59802
United States, Nebraska
Nebraska Medicine-Village Pointe
Omaha, Nebraska, United States, 68118
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, Nevada
Cancer and Blood Specialists-Henderson
Henderson, Nevada, United States, 89052
Ann M Wierman MD LTD
Las Vegas, Nevada, United States, 89128
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, United States, 89128
OptumCare Cancer Care at MountainView
Las Vegas, Nevada, United States, 89128
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, United States, 89144
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89148
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, United States, 89169
Renown Regional Medical Center
Reno, Nevada, United States, 89502
United States, New Jersey
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, United States, 08876
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Mount Sinai West
New York, New York, United States, 10019
NYP/Weill Cornell Medical Center
New York, New York, United States, 10065
University of Rochester
Rochester, New York, United States, 14642
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, United States, 28328
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, United States, 27534
Wayne Memorial Hospital
Goldsboro, North Carolina, United States, 27534
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, United States, 28546
WG Hefner VA Medical Center
Salisbury, North Carolina, United States, 28144
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States, 58501
Sanford Broadway Medical Center
Fargo, North Dakota, United States, 58122
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
United States, Ohio
Dayton Physician LLC-Miami Valley Hospital North
Dayton, Ohio, United States, 45415
Miami Valley Hospital North
Dayton, Ohio, United States, 45415
Kettering Medical Center
Kettering, Ohio, United States, 45429
Saint Rita's Medical Center
Lima, Ohio, United States, 45801
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, United States, 73120
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States, 74146
United States, Oregon
Saint Alphonsus Medical Center-Baker City
Baker City, Oregon, United States, 97814
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Saint Alphonsus Medical Center-Ontario
Ontario, Oregon, United States, 97914
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States, 97210
Legacy Meridian Park Hospital
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, United States, 19317
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
Prisma Health Cancer Institute - Laurens
Clinton, South Carolina, United States, 29325
Prisma Health Cancer Institute - Easley
Easley, South Carolina, United States, 29640
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, United States, 29605
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, United States, 29605
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, United States, 29605
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, United States, 29615
Prisma Health Cancer Institute - Greer
Greer, South Carolina, United States, 29650
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, United States, 29672
Prisma Health Cancer Institute - Spartanburg
Spartanburg, South Carolina, United States, 29307
United States, South Dakota
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0565
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77030
UTMB Cancer Center at Victory Lakes
League City, Texas, United States, 77573
Audie L Murphy VA Hospital
San Antonio, Texas, United States, 78229
University Hospital
San Antonio, Texas, United States, 78229
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
United States, Utah
Farmington Health Center
Farmington, Utah, United States, 84025
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
South Jordan Health Center
South Jordan, Utah, United States, 84009
United States, Virginia
Centra Lynchburg Hematology-Oncology Clinic Inc
Lynchburg, Virginia, United States, 24501
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States, 23298
United States, Washington
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
Legacy Salmon Creek Hospital
Vancouver, Washington, United States, 98686
United States, West Virginia
West Virginia University Charleston Division
Charleston, West Virginia, United States, 25304
United States, Wisconsin
Duluth Clinic Ashland
Ashland, Wisconsin, United States, 54806
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, United States, 53105
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, United States, 54729
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, United States, 54701
Aurora Health Center-Fond du Lac
Fond Du Lac, Wisconsin, United States, 54937
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, United States, 53022
Aurora Cancer Care-Grafton
Grafton, Wisconsin, United States, 53024
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54311
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, United States, 53142
Marshfield Clinic - Ladysmith Center
Ladysmith, Wisconsin, United States, 54848
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, United States, 54143
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States, 54449
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, United States, 53209
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States, 53233
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States, 54548
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States, 54904
Aurora Cancer Care-Racine
Racine, Wisconsin, United States, 53406
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, United States, 54868
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, United States, 53081
Marshfield Clinic Stevens Point Center
Stevens Point, Wisconsin, United States, 54482
Aurora Medical Center in Summit
Summit, Wisconsin, United States, 53066
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, United States, 54241
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, United States, 54401
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States, 53226
Aurora West Allis Medical Center
West Allis, Wisconsin, United States, 53227
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States, 54476
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States, 54494
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Quebec
The Research Institute of the McGill University Health Centre (MUHC)
Montreal, Quebec, Canada, H3H 2R9
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Sponsors and Collaborators
National Cancer Institute (NCI)
Canadian Cancer Trials Group
Investigators
Layout table for investigator information
Principal Investigator: Peter C Black Southwest Oncology Group

Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02844816     History of Changes
Other Study ID Numbers: NCI-2016-01104
NCI-2016-01104 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
S1605 ( Other Identifier: SWOG )
S1605 ( Other Identifier: CTEP )
U10CA180888 ( U.S. NIH Grant/Contract )
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Atezolizumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs