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

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ClinicalTrials.gov Identifier: NCT02844816
Recruitment Status : Recruiting
First Posted : July 26, 2016
Last Update Posted : May 17, 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 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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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 Suspended
Daphne, Alabama, United States, 36526
Southern Cancer Center PC-Mobile Suspended
Mobile, Alabama, United States, 36607
Southern Cancer Center PC-Providence Suspended
Mobile, Alabama, United States, 36608
Southern Cancer Center PC-Springhill Suspended
Mobile, Alabama, United States, 36608
United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Site Public Contact    855-776-0015      
Principal Investigator: Parminder Singh         
University of Arizona Cancer Center-Orange Grove Campus Recruiting
Tucson, Arizona, United States, 85704
Contact: Site Public Contact    520-694-8900      
Principal Investigator: Juan Chipollini         
Banner University Medical Center - Tucson Recruiting
Tucson, Arizona, United States, 85719
Contact: Site Public Contact       aselegue@email.arizona.edu   
Principal Investigator: Juan Chipollini         
University of Arizona Cancer Center-North Campus Recruiting
Tucson, Arizona, United States, 85719
Contact: Site Public Contact    800-327-2873      
Principal Investigator: Juan Chipollini         
United States, Arkansas
Veteran's Administration Medical Center Suspended
Little Rock, Arkansas, United States, 72205
United States, California
UC San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Site Public Contact    858-822-5354    cancercto@ucsd.edu   
Principal Investigator: Andrew K. Kader         
Los Angeles County-USC Medical Center Recruiting
Los Angeles, California, United States, 90033
Contact: Site Public Contact    323-865-0451      
Principal Investigator: Siamak Daneshmand         
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Site Public Contact    323-865-0451      
Principal Investigator: Siamak Daneshmand         
Stanford Cancer Institute Palo Alto Recruiting
Palo Alto, California, United States, 94304
Contact: Site Public Contact    650-498-7061    ccto-office@stanford.edu   
Principal Investigator: Eila C. Skinner         
Eisenhower Medical Center Recruiting
Rancho Mirage, California, United States, 92270
Contact: Site Public Contact    760-834-3798      
Principal Investigator: Varun Gupta         
University of California Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Site Public Contact    916-734-3089      
Principal Investigator: Marc Dall'Era         
UCSF Medical Center-Mission Bay Recruiting
San Francisco, California, United States, 94158
Contact: Site Public Contact    877-827-3222      
Principal Investigator: Sima P. Porten         
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Site Public Contact    720-848-0650      
Principal Investigator: Elizabeth R. Kessler         
Kaiser Permanente-Franklin Recruiting
Denver, Colorado, United States, 80205
Contact: Site Public Contact    303-764-5056    josh.b.gordon@nsmtp.kp.org   
Principal Investigator: Alexander Menter         
Kaiser Permanente-Rock Creek Recruiting
Lafayette, Colorado, United States, 80026
Contact: Site Public Contact    303-764-5056    josh.b.gordon@nsmtp.kp.org   
Principal Investigator: Alexander Menter         
Kaiser Permanente-Lone Tree Recruiting
Lone Tree, Colorado, United States, 80124
Contact: Site Public Contact    303-764-5056    josh.b.gordon@nsmtp.kp.org   
Principal Investigator: Alexander Menter         
United States, Connecticut
Greenwich Hospital Recruiting
Greenwich, Connecticut, United States, 06830
Contact: Site Public Contact    203-863-3698      
Principal Investigator: Beverly J. Drucker         
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Site Public Contact    203-785-5702    canceranswers@yale.edu   
Principal Investigator: Patrick A. Kenney         
Veterans Affairs Connecticut Healthcare System-West Haven Campus Recruiting
West Haven, Connecticut, United States, 06516
Contact: Site Public Contact    203-937-3421 ext 2832      
Principal Investigator: Michael S. Leapman         
United States, Delaware
Delaware Clinical and Laboratory Physicians PA Suspended
Newark, Delaware, United States, 19713
Helen F Graham Cancer Center Recruiting
Newark, Delaware, United States, 19713
Contact: Site Public Contact    302-623-4450    KDempsey@christianacare.org   
Principal Investigator: Gregory A. Masters         
Medical Oncology Hematology Consultants PA Recruiting
Newark, Delaware, United States, 19713
Contact: Site Public Contact    302-623-4450    KDempsey@christianacare.org   
Principal Investigator: Gregory A. Masters         
Regional Hematology and Oncology PA Suspended
Newark, Delaware, United States, 19713
Christiana Care Health System-Christiana Hospital Suspended
Newark, Delaware, United States, 19718
Christiana Care Health System-Wilmington Hospital Suspended
Wilmington, Delaware, United States, 19801
United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Site Public Contact    202-877-8839      
Principal Investigator: Lambros Stamatakis         
George Washington University Medical Center Recruiting
Washington, District of Columbia, United States, 20037
Contact: Site Public Contact    202-741-2981      
Principal Investigator: Michael J. Whalen         
United States, Florida
Mount Sinai Comprehensive Cancer Center at Aventura Suspended
Aventura, Florida, United States, 33180
University of Florida Health Science Center - Gainesville Recruiting
Gainesville, Florida, United States, 32610
Contact: Site Public Contact    352-273-8010    cancer-center@ufl.edu   
Principal Investigator: Paul L. Crispen         
Mount Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Site Public Contact    305-674-2625    yenrique@msmc.com   
Principal Investigator: Michael A. Schwartz         
Indian River Medical Center Recruiting
Vero Beach, Florida, United States, 32960
Contact: Site Public Contact    772-563-4673      
Principal Investigator: James M. Grichnik         
United States, Georgia
Emory University Hospital/Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Site Public Contact    404-778-1868      
Principal Investigator: Bradley C. Carthon         
Atlanta VA Medical Center Suspended
Decatur, Georgia, United States, 30033
United States, Hawaii
Pali Momi Medical Center Recruiting
'Aiea, Hawaii, United States, 96701
Contact: Site Public Contact    808-486-6000      
Principal Investigator: Jared D. Acoba         
Hawaii Cancer Care Inc-POB II Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Site Public Contact    808-524-6115      
Principal Investigator: Jared D. Acoba         
Hawaii Oncology Inc-POB I Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Site Public Contact    808-532-0315      
Principal Investigator: Jared D. Acoba         
Island Urology Suspended
Honolulu, Hawaii, United States, 96813
Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Site Public Contact       protocols@swog.org   
Principal Investigator: Jared D. Acoba         
Straub Clinic and Hospital Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Site Public Contact    808-522-4333      
Principal Investigator: Jared D. Acoba         
University of Hawaii Cancer Center Suspended
Honolulu, Hawaii, United States, 96813
Hawaii Oncology Inc-Kuakini Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Site Public Contact    808-531-8521      
Principal Investigator: Jared D. Acoba         
Kapiolani Medical Center for Women and Children Suspended
Honolulu, Hawaii, United States, 96826
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise Recruiting
Boise, Idaho, United States, 83706
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Benjamin T. Marchello         
Saint Luke's Mountain States Tumor Institute Recruiting
Boise, Idaho, United States, 83712
Contact: Site Public Contact       protocols@swog.org   
Principal Investigator: Gary E. Goodman         
Saint Alphonsus Cancer Care Center-Caldwell Recruiting
Caldwell, Idaho, United States, 83605
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Benjamin T. Marchello         
Walter Knox Memorial Hospital Suspended
Emmett, Idaho, United States, 83617
Idaho Urologic Institute-Meridian Recruiting
Meridian, Idaho, United States, 83642
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Benjamin T. Marchello         
Saint Luke's Mountain States Tumor Institute - Meridian Recruiting
Meridian, Idaho, United States, 83642
Contact: Site Public Contact       protocols@swog.org   
Principal Investigator: Gary E. Goodman         
Saint Alphonsus Medical Center-Nampa Recruiting
Nampa, Idaho, United States, 83686
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Benjamin T. Marchello         
Saint Luke's Mountain States Tumor Institute-Twin Falls Recruiting
Twin Falls, Idaho, United States, 83301
Contact: Site Public Contact       protocols@swog.org   
Principal Investigator: Gary E. Goodman         
United States, Illinois
Rush - Copley Medical Center Recruiting
Aurora, Illinois, United States, 60504
Contact: Site Public Contact    630-978-6212    Cancer.Research@rushcopley.com   
Principal Investigator: Priyank P. Patel         
Illinois CancerCare-Bloomington Recruiting
Bloomington, Illinois, United States, 61704
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Canton Recruiting
Canton, Illinois, United States, 61520
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Carthage Recruiting
Carthage, Illinois, United States, 62321
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Centralia Oncology Clinic Suspended
Centralia, Illinois, United States, 62801
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Site Public Contact    312-695-1301    cancer@northwestern.edu   
Principal Investigator: Joshua J. Meeks         
Carle on Vermilion Recruiting
Danville, Illinois, United States, 61832
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Priyank P. Patel         
Cancer Care Specialists of Illinois - Decatur Recruiting
Decatur, Illinois, United States, 62526
Contact: Site Public Contact    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Decatur Memorial Hospital Suspended
Decatur, Illinois, United States, 62526
Carle Physician Group-Effingham Recruiting
Effingham, Illinois, United States, 62401
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Priyank P. Patel         
Crossroads Cancer Center Recruiting
Effingham, Illinois, United States, 62401
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Elmhurst Memorial Hospital Active, not recruiting
Elmhurst, Illinois, United States, 60126
Illinois CancerCare-Eureka Recruiting
Eureka, Illinois, United States, 61530
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Galesburg Recruiting
Galesburg, Illinois, United States, 61401
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Edward Hines Jr VA Hospital Suspended
Hines, Illinois, United States, 60141
Illinois CancerCare-Kewanee Clinic Recruiting
Kewanee, Illinois, United States, 61443
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Macomb Recruiting
Macomb, Illinois, United States, 61455
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Carle Physician Group-Mattoon/Charleston Recruiting
Mattoon, Illinois, United States, 61938
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Priyank P. Patel         
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Site Public Contact    708-226-4357      
Principal Investigator: Elizabeth Henry         
Good Samaritan Regional Health Center Recruiting
Mount Vernon, Illinois, United States, 62864
Contact: Site Public Contact    618-242-4600      
Principal Investigator: Jay W. Carlson         
Edward Hospital/Cancer Center Active, not recruiting
Naperville, Illinois, United States, 60540
Illinois CancerCare-Ottawa Clinic Recruiting
Ottawa, Illinois, United States, 61350
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Pekin Recruiting
Pekin, Illinois, United States, 61554
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Peoria Recruiting
Peoria, Illinois, United States, 61615
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Methodist Medical Center of Illinois Suspended
Peoria, Illinois, United States, 61636
OSF Saint Francis Medical Center Suspended
Peoria, Illinois, United States, 61637
Illinois CancerCare-Peru Recruiting
Peru, Illinois, United States, 61354
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Edward Hospital/Cancer Center?Plainfield Active, not recruiting
Plainfield, Illinois, United States, 60585
Illinois CancerCare-Princeton Recruiting
Princeton, Illinois, United States, 61356
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Southern Illinois University School of Medicine Recruiting
Springfield, Illinois, United States, 62702
Contact: Site Public Contact    217-545-7929      
Principal Investigator: Bryan A. Faller         
Springfield Clinic Recruiting
Springfield, Illinois, United States, 62702
Contact: Site Public Contact    800-444-7541      
Principal Investigator: Bryan A. Faller         
Memorial Medical Center Suspended
Springfield, Illinois, United States, 62781
Carle Cancer Center Recruiting
Urbana, Illinois, United States, 61801
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Priyank P. Patel         
The Carle Foundation Hospital Recruiting
Urbana, Illinois, United States, 61801
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Priyank P. Patel         
Rush-Copley Healthcare Center Recruiting
Yorkville, Illinois, United States, 60560
Contact: Site Public Contact    630-978-6212    Cancer.Research@rushcopley.com   
Principal Investigator: Priyank P. Patel         
United States, Indiana
Indiana University/Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Site Public Contact    317-278-5632    iutrials@iu.edu   
Principal Investigator: Nabil Adra         
Community Cancer Center East Recruiting
Indianapolis, Indiana, United States, 46219
Contact: Site Public Contact    800-777-7775    lcheri@ecommunity.com   
Principal Investigator: Natraj R. Ammakkanavar         
Community Cancer Center South Recruiting
Indianapolis, Indiana, United States, 46227
Contact: Site Public Contact    317-497-2823    lcheri@ecommunity.com   
Principal Investigator: Natraj R. Ammakkanavar         
Community Cancer Center North Recruiting
Indianapolis, Indiana, United States, 46256
Contact: Site Public Contact    317-621-7104    lcheri@ecommunity.com   
Principal Investigator: Natraj R. Ammakkanavar         
Community Howard Regional Health Recruiting
Kokomo, Indiana, United States, 46904
Contact: Site Public Contact    765-453-8571    oncology@communityhoward.org   
Principal Investigator: Natraj R. Ammakkanavar         
Reid Health Recruiting
Richmond, Indiana, United States, 47374
Contact: Site Public Contact    937-775-1350    som_dcop@wright.edu   
Principal Investigator: Howard M. Gross         
United States, Kansas
Cancer Center of Kansas - Chanute Suspended
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City Suspended
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - El Dorado Suspended
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott Suspended
Fort Scott, Kansas, United States, 66701
Hays Medical Center Recruiting
Hays, Kansas, United States, 67601
Contact: Site Public Contact    785-623-5774      
Principal Investigator: Eugene K. Lee         
Cancer Center of Kansas-Independence Suspended
Independence, Kansas, United States, 67301
University of Kansas Cancer Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Site Public Contact    913-945-7552    ctnursenav@kumc.edu   
Principal Investigator: Eugene K. Lee         
Cancer Center of Kansas-Kingman Suspended
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital Recruiting
Lawrence, Kansas, United States, 66044
Contact: Site Public Contact    316-268-5374    Keisha.humphries@ascension.org   
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Liberal Suspended
Liberal, Kansas, United States, 67905
Cancer Center of Kansas-Manhattan Suspended
Manhattan, Kansas, United States, 66502
Cancer Center of Kansas - McPherson Suspended
McPherson, Kansas, United States, 67460
Cancer Center of Kansas - Newton Suspended
Newton, Kansas, United States, 67114
Olathe Medical Center Recruiting
Olathe, Kansas, United States, 66061
Contact: Site Public Contact    913-791-3500    Jeni.wakefield@olathehealth.org   
Principal Investigator: Eugene K. Lee         
Cancer Center of Kansas - Parsons Suspended
Parsons, Kansas, United States, 67357
Via Christi Hospital-Pittsburg Recruiting
Pittsburg, Kansas, United States, 66762
Contact: Site Public Contact    620-235-7900      
Principal Investigator: Eugene K. Lee         
Cancer Center of Kansas - Pratt Suspended
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina Suspended
Salina, Kansas, United States, 67401
Salina Regional Health Center Recruiting
Salina, Kansas, United States, 67401
Contact: Site Public Contact    785-452-7038    kkavoura@srhc.com   
Principal Investigator: Eugene K. Lee         
Saint Francis Hospital and Medical Center - Topeka Recruiting
Topeka, Kansas, United States, 66606
Contact: Site Public Contact    785-295-8000      
Principal Investigator: Eugene K. Lee         
Cancer Center of Kansas - Wellington Suspended
Wellington, Kansas, United States, 67152
University of Kansas Hospital-Westwood Cancer Center Recruiting
Westwood, Kansas, United States, 66205
Contact: Site Public Contact    913-945-7552    ctnursenav@kumc.edu   
Principal Investigator: Eugene K. Lee         
Cancer Center of Kansas-Wichita Medical Arts Tower Recruiting
Wichita, Kansas, United States, 67208
Contact: Site Public Contact    316-268-5374    Keisha.humphries@ascension.org   
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Wichita Recruiting
Wichita, Kansas, United States, 67214
Contact: Site Public Contact    316-268-5374    Keisha.humphries@ascension.org   
Principal Investigator: Shaker R. Dakhil         
Via Christi Regional Medical Center Suspended
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Winfield Suspended
Winfield, Kansas, United States, 67156
United States, Kentucky
University of Kentucky/Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Site Public Contact    859-257-3379      
Principal Investigator: Andrew C. James         
United States, Louisiana
East Jefferson General Hospital Recruiting
Metairie, Louisiana, United States, 70006
Contact: Site Public Contact    504-210-3539    emede1@lsuhsc.edu   
Principal Investigator: Scott E. Delacroix         
LSU Healthcare Network / Metairie Multi-Specialty Clinic Recruiting
Metairie, Louisiana, United States, 70006
Contact: Site Public Contact    504-210-3539    emede1@lsuhsc.edu   
Principal Investigator: Scott E. Delacroix         
Louisiana State University Health Science Center Suspended
New Orleans, Louisiana, United States, 70112
Louisiana State University Health Sciences Center Shreveport Recruiting
Shreveport, Louisiana, United States, 71103
Contact: Site Public Contact    318-813-1422    JRowel@lsuhsc.edu   
Principal Investigator: Kara N. Babaian         
United States, Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Site Public Contact    410-955-8804    jhcccro@jhmi.edu   
Principal Investigator: Trinity J. Bivalacqua         
United States, Massachusetts
Boston Medical Center Active, not recruiting
Boston, Massachusetts, United States, 02118
Lowell General Hospital Recruiting
Lowell, Massachusetts, United States, 01854
Contact: Site Public Contact    978-788-7084    ghincks@lowellgeneral.org   
Principal Investigator: Richard M. Zuniga         
United States, Michigan
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
IHA Hematology Oncology Consultants-Brighton Recruiting
Brighton, Michigan, United States, 48114
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
Saint Joseph Mercy Brighton Recruiting
Brighton, Michigan, United States, 48114
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
IHA Hematology Oncology Consultants-Canton Recruiting
Canton, Michigan, United States, 48188
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
Saint Joseph Mercy Canton Recruiting
Canton, Michigan, United States, 48188
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
Caro Cancer Center Recruiting
Caro, Michigan, United States, 48723
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
IHA Hematology Oncology Consultants-Chelsea Recruiting
Chelsea, Michigan, United States, 48118
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
Saint Joseph Mercy Chelsea Recruiting
Chelsea, Michigan, United States, 48118
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
Hematology Oncology Consultants-Clarkston Recruiting
Clarkston, Michigan, United States, 48346
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
Newland Medical Associates-Clarkston Recruiting
Clarkston, Michigan, United States, 48346
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
Michigan State University Clinical Center Recruiting
East Lansing, Michigan, United States, 48824-7016
Contact: Site Public Contact    517-975-9547      
Principal Investigator: Jatin Rana         
Genesee Cancer and Blood Disease Treatment Center Suspended
Flint, Michigan, United States, 48503
Genesee Hematology Oncology PC Suspended
Flint, Michigan, United States, 48503
Genesys Hurley Cancer Institute Suspended
Flint, Michigan, United States, 48503
Sparrow Hospital Recruiting
Lansing, Michigan, United States, 48912
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
Saint Mary's Oncology/Hematology Associates of Marlette Recruiting
Marlette, Michigan, United States, 48453
Contact: Site Public Contact    989-343-2487      
Principal Investigator: Tareq Al Baghdadi         
Newland Medical Associates-Pontiac Recruiting
Pontiac, Michigan, United States, 48341
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
Saint Joseph Mercy Oakland Recruiting
Pontiac, Michigan, United States, 48341
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
Ascension Saint Mary's Hospital Recruiting
Saginaw, Michigan, United States, 48601
Contact: Site Public Contact       protocols@swog.org   
Principal Investigator: Tareq Al Baghdadi         
Oncology Hematology Associates of Saginaw Valley PC Recruiting
Saginaw, Michigan, United States, 48604
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
Saint Mary's Oncology/Hematology Associates of West Branch Recruiting
West Branch, Michigan, United States, 48661
Contact: Site Public Contact    989-343-2487      
Principal Investigator: Tareq Al Baghdadi         
Huron Gastroenterology PC Suspended
Ypsilanti, Michigan, United States, 48106
IHA Hematology Oncology Consultants-Ann Arbor Recruiting
Ypsilanti, Michigan, United States, 48197
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Tareq Al Baghdadi         
United States, Minnesota
Fairview Ridges Hospital Suspended
Burnsville, Minnesota, United States, 55337
Essentia Health Cancer Center Recruiting
Duluth, Minnesota, United States, 55805
Contact: Site Public Contact    218-786-3308    CancerTrials@EssentiaHealth.org   
Principal Investigator: Bret E. Friday         
Essentia Health Saint Mary's Medical Center Suspended
Duluth, Minnesota, United States, 55805
Miller-Dwan Hospital Suspended
Duluth, Minnesota, United States, 55805
Saint Luke's Hospital of Duluth Recruiting
Duluth, Minnesota, United States, 55805
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Homam Alkaied         
Fairview-Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: David M. King         
Coborn Cancer Center at Saint Cloud Hospital Recruiting
Saint Cloud, Minnesota, United States, 56303
Contact: Site Public Contact    877-229-4907    coborncancercenter@centracare.com   
Principal Investigator: Donald J. Jurgens         
Saint Cloud Hospital Suspended
Saint Cloud, Minnesota, United States, 56303
Park Nicollet Clinic - Saint Louis Park Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: David M. King         
Essentia Health Virginia Clinic Recruiting
Virginia, Minnesota, United States, 55792
Contact: Site Public Contact    218-786-3308    CancerTrials@EssentiaHealth.org   
Principal Investigator: Bret E. Friday         
Fairview Lakes Medical Center Recruiting
Wyoming, Minnesota, United States, 55092
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: David M. King         
United States, Missouri
Parkland Health Center-Bonne Terre Recruiting
Bonne Terre, Missouri, United States, 63628
Contact: Site Public Contact    314-996-5569      
Principal Investigator: Bryan A. Faller         
Saint Francis Medical Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Site Public Contact    573-334-2230    sfmc@sfmc.net   
Principal Investigator: Bryan A. Faller         
Southeast Cancer Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Site Public Contact    573-651-5550      
Principal Investigator: Bryan A. Faller         
University of Missouri - Ellis Fischel Recruiting
Columbia, Missouri, United States, 65212
Contact: Site Public Contact    573-882-7440      
Principal Investigator: Puja Nistala         
Kansas City Veterans Affairs Medical Center Suspended
Kansas City, Missouri, United States, 64128
Missouri Baptist Medical Center Recruiting
Saint Louis, Missouri, United States, 63131
Contact: Site Public Contact    314-996-5569      
Principal Investigator: Bryan A. Faller         
Sainte Genevieve County Memorial Hospital Recruiting
Sainte Genevieve, Missouri, United States, 63670
Contact: Site Public Contact    314-996-5569      
Principal Investigator: Bryan A. Faller         
Missouri Baptist Sullivan Hospital Recruiting
Sullivan, Missouri, United States, 63080
Contact: Site Public Contact    314-996-5569      
Principal Investigator: Bryan A. Faller         
Missouri Baptist Outpatient Center-Sunset Hills Recruiting
Sunset Hills, Missouri, United States, 63127
Contact: Site Public Contact    314-996-5569      
Principal Investigator: Bryan A. Faller         
United States, Montana
Benefis Healthcare- Sletten Cancer Institute Recruiting
Great Falls, Montana, United States, 59405
Contact: Site Public Contact    406-969-6060    mccinfo@mtcancer.org   
Principal Investigator: Benjamin T. Marchello         
Saint Patrick Hospital - Community Hospital Recruiting
Missoula, Montana, United States, 59802
Contact: Site Public Contact    406-327-3118    amy.hanneman@providence.org   
Principal Investigator: Gary E. Goodman         
United States, Nebraska
Nebraska Medicine-Village Pointe Recruiting
Omaha, Nebraska, United States, 68118
Contact: Site Public Contact    402-559-5600      
Principal Investigator: Shawna L. Boyle         
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Site Public Contact    402-559-6941    unmcrsa@unmc.edu   
Principal Investigator: Shawna L. Boyle         
United States, Nevada
Cancer and Blood Specialists-Henderson Suspended
Henderson, Nevada, United States, 89052
Ann M Wierman MD LTD Suspended
Las Vegas, Nevada, United States, 89128
Comprehensive Cancer Centers of Nevada - Northwest Suspended
Las Vegas, Nevada, United States, 89128
OptumCare Cancer Care at MountainView Recruiting
Las Vegas, Nevada, United States, 89128
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: John A. Ellerton         
Comprehensive Cancer Centers of Nevada - Town Center Recruiting
Las Vegas, Nevada, United States, 89144
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: John A. Ellerton         
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89148
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: John A. Ellerton         
Comprehensive Cancer Centers of Nevada - Central Valley Recruiting
Las Vegas, Nevada, United States, 89169
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: John A. Ellerton         
Renown Regional Medical Center Suspended
Reno, Nevada, United States, 89502
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Site Public Contact    800-767-9355    askroswell@roswellpark.org   
Principal Investigator: Qiang J. Li         
Mount Sinai West Recruiting
New York, New York, United States, 10019
Contact: Site Public Contact    212-523-4000    CCTO@mssm.edu   
Principal Investigator: Gabriel A. Sara         
NYP/Weill Cornell Medical Center Recruiting
New York, New York, United States, 10065
Contact: Site Public Contact    212-746-1848      
Principal Investigator: Scott T. Tagawa         
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Site Public Contact    585-275-5830      
Principal Investigator: Paul M. Barr         
State University of New York Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Site Public Contact    315-464-5476      
Principal Investigator: Joseph M. Jacob         
United States, North Carolina
Southeastern Medical Oncology Center-Clinton Recruiting
Clinton, North Carolina, United States, 28328
Contact: Site Public Contact    919-587-9077    ecooke@cancersmoc.com   
Principal Investigator: Nagesh H. Jayaram         
Southeastern Medical Oncology Center-Goldsboro Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: Site Public Contact    919-587-9077    ecooke@cancersmoc.com   
Principal Investigator: Nagesh H. Jayaram         
Wayne Memorial Hospital Suspended
Goldsboro, North Carolina, United States, 27534
Southeastern Medical Oncology Center-Jacksonville Recruiting
Jacksonville, North Carolina, United States, 28546
Contact: Site Public Contact    910-353-0824    ecooke@cancersmoc.com   
Principal Investigator: Nagesh H. Jayaram         
Veterans Administration Medical Center Suspended
Salisbury, North Carolina, United States, 28144
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Site Public Contact    336-713-6771      
Principal Investigator: Christopher Y. Thomas         
United States, North Dakota
Sanford Bismarck Medical Center Recruiting
Bismarck, North Dakota, United States, 58501
Contact: Site Public Contact    701-323-5760    OncologyClinicalTrialsFargo@sanfordhealth.org   
Principal Investigator: Preston D. Steen         
Sanford Broadway Medical Center Recruiting
Fargo, North Dakota, United States, 58122
Contact: Site Public Contact    701-323-5760    OncologyClinicalTrialsFargo@sanfordhealth.org   
Principal Investigator: Preston D. Steen         
Sanford Roger Maris Cancer Center Recruiting
Fargo, North Dakota, United States, 58122
Contact: Site Public Contact    701-234-6161    OncologyClinicalTrialsFargo@sanfordhealth.org   
Principal Investigator: Preston D. Steen         
United States, Ohio
Dayton Physician LLC-Miami Valley Hospital North Recruiting
Dayton, Ohio, United States, 45415
Contact: Site Public Contact    937-775-1350    som_dcop@wright.edu   
Principal Investigator: Howard M. Gross         
Miami Valley Hospital North Recruiting
Dayton, Ohio, United States, 45415
Contact: Site Public Contact    937-832-1093    som_dcop@wright.edu   
Principal Investigator: Howard M. Gross         
Kettering Medical Center Recruiting
Kettering, Ohio, United States, 45429
Contact: Site Public Contact    937-775-1350    som_dcop@wright.edu   
Principal Investigator: Howard M. Gross         
Saint Rita's Medical Center Suspended
Lima, Ohio, United States, 45801
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Site Public Contact    405-271-8777    ou-clinical-trials@ouhsc.edu   
Principal Investigator: Kelly L. Stratton         
Mercy Hospital Oklahoma City Suspended
Oklahoma City, Oklahoma, United States, 73120
Oklahoma Cancer Specialists and Research Institute-Tulsa Recruiting
Tulsa, Oklahoma, United States, 74146
Contact: Site Public Contact    918-505-3200      
Principal Investigator: Kelly L. Stratton         
United States, Oregon
Saint Alphonsus Medical Center-Baker City Suspended
Baker City, Oregon, United States, 97814
Legacy Mount Hood Medical Center Suspended
Gresham, Oregon, United States, 97030
Saint Alphonsus Medical Center-Ontario Recruiting
Ontario, Oregon, United States, 97914
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Benjamin T. Marchello         
Legacy Good Samaritan Hospital and Medical Center Recruiting
Portland, Oregon, United States, 97210
Contact: Site Public Contact    800-220-4937    cancer@lhs.org   
Principal Investigator: Jacqueline Vuky         
Legacy Meridian Park Hospital Recruiting
Tualatin, Oregon, United States, 97062
Contact: Site Public Contact    503-413-1742      
Principal Investigator: Jacqueline Vuky         
United States, Pennsylvania
Christiana Care Health System-Concord Health Center Suspended
Chadds Ford, Pennsylvania, United States, 19317
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Site Public Contact    877-284-2000      
Principal Investigator: Ralph J. Miller         
United States, South Carolina
Greenville Health System Cancer Institute-Laurens Suspended
Clinton, South Carolina, United States, 29325
Greenville Health System Cancer Institute-Easley Recruiting
Easley, South Carolina, United States, 29640
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey K. Giguere         
Greenville Health System Cancer Institute-Butternut Recruiting
Greenville, South Carolina, United States, 29605
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey K. Giguere         
Greenville Health System Cancer Institute-Faris Recruiting
Greenville, South Carolina, United States, 29605
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey K. Giguere         
Greenville Memorial Hospital Suspended
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Eastside Recruiting
Greenville, South Carolina, United States, 29615
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey K. Giguere         
Greenville Health System Cancer Institute-Greer Recruiting
Greer, South Carolina, United States, 29650
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey K. Giguere         
Greenville Health System Cancer Institute-Seneca Recruiting
Seneca, South Carolina, United States, 29672
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey K. Giguere         
Greenville Health System Cancer Institute-Spartanburg Recruiting
Spartanburg, South Carolina, United States, 29307
Contact: Site Public Contact    864-241-6251    kwilliams8@ghs.org   
Principal Investigator: Jeffrey K. Giguere         
United States, South Dakota
Sanford Cancer Center Oncology Clinic Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Site Public Contact    605-312-3320    OncologyClinicTrialsSF@sanfordhealth.org   
Principal Investigator: Preston D. Steen         
Sanford USD Medical Center - Sioux Falls Recruiting
Sioux Falls, South Dakota, United States, 57117-5134
Contact: Site Public Contact    605-312-3320    OncologyClinicalTrialsSF@SanfordHealth.org   
Principal Investigator: Preston D. Steen         
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555-0565
Contact: Site Public Contact    409-772-1950    clinical.research@utmb.edu   
Principal Investigator: Stephen B. Williams         
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Site Public Contact    713-798-1354    burton@bcm.edu   
Principal Investigator: Seth P. Lerner         
UTMB Cancer Center at Victory Lakes Suspended
League City, Texas, United States, 77573
Audie L Murphy VA Hospital Recruiting
San Antonio, Texas, United States, 78229
Contact: Site Public Contact    877-469-5300      
Principal Investigator: Paromita Datta         
University Hospital Active, not recruiting
San Antonio, Texas, United States, 78229
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Site Public Contact    210-450-3800    phoresearchoffice@uthscsa.edu   
Principal Investigator: Chethan Ramamurthy         
United States, Utah
Farmington Health Center Recruiting
Farmington, Utah, United States, 84025
Contact: Site Public Contact    888-424-2100    cancerinfo@hci.utah.edu   
Principal Investigator: William T. Lowrance         
Huntsman Cancer Institute/University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Site Public Contact    888-424-2100    cancerinfo@hci.utah.edu   
Principal Investigator: William T. Lowrance         
South Jordan Health Center Suspended
South Jordan, Utah, United States, 84009
United States, Virginia
Centra Lynchburg Hematology-Oncology Clinic Inc Recruiting
Lynchburg, Virginia, United States, 24501
Contact: Site Public Contact    434-200-5925    Kevin.Patel@centrahealth.com   
Principal Investigator: Asit K. Paul         
Virginia Commonwealth University/Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Site Public Contact       mwellons@vcu.edu   
Principal Investigator: Asit K. Paul         
United States, Washington
Swedish Medical Center-First Hill Recruiting
Seattle, Washington, United States, 98122-4307
Contact: Site Public Contact    206-215-3086    PCRC-NCORP@Swedish.org   
Principal Investigator: Gary E. Goodman         
Legacy Salmon Creek Hospital Recruiting
Vancouver, Washington, United States, 98686
Contact: Site Public Contact    503-413-2150      
Principal Investigator: Jacqueline Vuky         
United States, West Virginia
West Virginia University Charleston Division Recruiting
Charleston, West Virginia, United States, 25304
Contact: Site Public Contact    304-388-9944      
Principal Investigator: Steven J. Jubelirer         
United States, Wisconsin
Duluth Clinic Ashland Recruiting
Ashland, Wisconsin, United States, 54806
Contact: Site Public Contact    218-786-3308    CancerTrials@EssentiaHealth.org   
Principal Investigator: Bret E. Friday         
Aurora Cancer Care-Southern Lakes VLCC Recruiting
Burlington, Wisconsin, United States, 53105
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Antony Ruggeri         
Marshfield Clinic-Chippewa Center Recruiting
Chippewa Falls, Wisconsin, United States, 54729
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Seth O. Fagbemi         
Marshfield Medical Center-EC Cancer Center Recruiting
Eau Claire, Wisconsin, United States, 54701
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Seth O. Fagbemi         
Aurora Health Center-Fond du Lac Recruiting
Fond Du Lac, Wisconsin, United States, 54937
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Antony Ruggeri         
Aurora Health Care Germantown Health Center Recruiting
Germantown, Wisconsin, United States, 53022
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Antony Ruggeri         
Aurora Cancer Care-Grafton Recruiting
Grafton, Wisconsin, United States, 53024
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Antony Ruggeri         
Aurora BayCare Medical Center Recruiting
Green Bay, Wisconsin, United States, 54311
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Antony Ruggeri         
Aurora Cancer Care-Kenosha South Recruiting
Kenosha, Wisconsin, United States, 53142
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Antony Ruggeri         
Marshfield Clinic - Ladysmith Center Recruiting
Ladysmith, Wisconsin, United States, 54848
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Seth O. Fagbemi         
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Site Public Contact    800-622-8922      
Principal Investigator: Hamid Emamekhoo         
Aurora Bay Area Medical Group-Marinette Suspended
Marinette, Wisconsin, United States, 54143
Marshfield Medical Center-Marshfield Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Seth O. Fagbemi         
Aurora Cancer Care-Milwaukee Recruiting
Milwaukee, Wisconsin, United States, 53209
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Antony Ruggeri         
Aurora Saint Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Antony Ruggeri         
Aurora Sinai Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53233
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Antony Ruggeri         
Marshfield Clinic-Minocqua Center Recruiting
Minocqua, Wisconsin, United States, 54548
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Seth O. Fagbemi         
Vince Lombardi Cancer Clinic - Oshkosh Recruiting
Oshkosh, Wisconsin, United States, 54904
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Antony Ruggeri         
Aurora Cancer Care-Racine Recruiting
Racine, Wisconsin, United States, 53406
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Antony Ruggeri         
Marshfield Medical Center-Rice Lake Recruiting
Rice Lake, Wisconsin, United States, 54868
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Seth O. Fagbemi         
Vince Lombardi Cancer Clinic-Sheboygan Recruiting
Sheboygan, Wisconsin, United States, 53081
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Antony Ruggeri         
Marshfield Clinic Stevens Point Center Recruiting
Stevens Point, Wisconsin, United States, 54482
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Seth O. Fagbemi         
Aurora Medical Center in Summit Recruiting
Summit, Wisconsin, United States, 53066
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Antony Ruggeri         
Vince Lombardi Cancer Clinic-Two Rivers Recruiting
Two Rivers, Wisconsin, United States, 54241
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Antony Ruggeri         
Marshfield Clinic-Wausau Center Recruiting
Wausau, Wisconsin, United States, 54401
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Seth O. Fagbemi         
Aurora Cancer Care-Milwaukee West Recruiting
Wauwatosa, Wisconsin, United States, 53226
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Antony Ruggeri         
Aurora West Allis Medical Center Recruiting
West Allis, Wisconsin, United States, 53227
Contact: Site Public Contact    414-302-2304    ncorp@aurora.org   
Principal Investigator: Antony Ruggeri         
Marshfield Clinic - Weston Center Recruiting
Weston, Wisconsin, United States, 54476
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Seth O. Fagbemi         
Marshfield Clinic - Wisconsin Rapids Center Recruiting
Wisconsin Rapids, Wisconsin, United States, 54494
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Seth O. Fagbemi         
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Site Public Contact    780-432-8500      
Principal Investigator: Scott A. North         
Canada, Quebec
The Research Institute of the McGill University Health Centre (MUHC) Recruiting
Montreal, Quebec, Canada, H3H 2R9
Contact: Site Public Contact    514-934-1934 ext 48354    evelyn.ortega@muhc.mcgill.ca   
Principal Investigator: Wassim Kassouf         
Canada, Saskatchewan
Allan Blair Cancer Centre Recruiting
Regina, Saskatchewan, Canada, S4T 7T1
Contact: Site Public Contact    306-766-2213      
Principal Investigator: Muhammad Salim         
Sponsors and Collaborators
National Cancer Institute (NCI)
Canadian Cancer Trials Group
Investigators
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Principal Investigator: Peter C Black Southwest Oncology Group

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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: May 17, 2019
Last Verified: January 2019

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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