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

• Sponsor: National Cancer Institute (NCI) (NIH)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02844816
• Collaborator: Canadian Cancer Trials Group (Other)
• Enrollment: 202
• Locations: 272
• Arm: 1
• Anticipated Duration (Months): 69.7
• Patients Per Site: 0.7
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This phase II trial studies how well atezolizumab works in treating patients with non-muscle invasive bladder cancer that has come back (recurrent) and has not responded to treatment (refractory) 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 OBJECTIVE:

1. 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:

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

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

ADDITIONAL OBJECTIVES:

1. 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).

2. 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 202 participants
• Allocation: N/A
• 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: Feb 7, 2017
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Complete response (CR) rate in the subset of patients with carcinoma in situ (CIS) based on biopsy [At 25 weeks]

   Will be estimated to within +/- 12% (95% confidence interval).

2. Event-free survival (EFS) [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 [18 months]

   Will estimate for the subset of patients with papillary cancer (Ta/T1).

2. Progression-free survival (PFS) [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 [Up to 5 years]

   Estimated using Kaplan-Meier.

4. Bladder cancer specific survival [From date of registration to date of death due to bladder cancer, assessed up to 5 years]

   Estimated using Kaplan-Meier.

5. Overall survival [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 [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 [Up to 5 years]

   Will estimate the level of agreement between local and central pathology review.

2. CR for the CIS subset [Up to 5 years]

   Will estimate the level of agreement between local and central pathology review.

3. PD-L1 and CD8 expression [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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/T1 recurrence (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

• 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

• 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 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

Exclusion Criteria:

• 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

• 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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southern Cancer Center PC-Daphne	Daphne	Alabama	United States	36526
2	Southern Cancer Center PC-Mobile	Mobile	Alabama	United States	36607
3	Southern Cancer Center PC-Providence	Mobile	Alabama	United States	36608
4	Southern Cancer Center PC-Springhill	Mobile	Alabama	United States	36608
5	Mayo Clinic in Arizona	Scottsdale	Arizona	United States	85259
6	University of Arizona Cancer Center-Orange Grove Campus	Tucson	Arizona	United States	85704
7	Banner University Medical Center - Tucson	Tucson	Arizona	United States	85719
8	University of Arizona Cancer Center-North Campus	Tucson	Arizona	United States	85719
9	John L McClellan Memorial Veterans Hospital	Little Rock	Arkansas	United States	72205
10	UC San Diego Moores Cancer Center	La Jolla	California	United States	92093
11	Los Angeles County-USC Medical Center	Los Angeles	California	United States	90033
12	USC / Norris Comprehensive Cancer Center	Los Angeles	California	United States	90033
13	Stanford Cancer Institute Palo Alto	Palo Alto	California	United States	94304
14	Eisenhower Medical Center	Rancho Mirage	California	United States	92270
15	University of California Davis Comprehensive Cancer Center	Sacramento	California	United States	95817
16	UCSF Medical Center-Mission Bay	San Francisco	California	United States	94158
17	University of Colorado Hospital	Aurora	Colorado	United States	80045
18	Kaiser Permanente-Franklin	Denver	Colorado	United States	80205
19	Kaiser Permanente-Rock Creek	Lafayette	Colorado	United States	80026
20	Kaiser Permanente-Lone Tree	Lone Tree	Colorado	United States	80124
21	Greenwich Hospital	Greenwich	Connecticut	United States	06830
22	Yale University	New Haven	Connecticut	United States	06520
23	Veterans Affairs Connecticut Healthcare System-West Haven Campus	West Haven	Connecticut	United States	06516
24	Delaware Clinical and Laboratory Physicians PA	Newark	Delaware	United States	19713
25	Helen F Graham Cancer Center	Newark	Delaware	United States	19713
26	Medical Oncology Hematology Consultants PA	Newark	Delaware	United States	19713
27	Christiana Care Health System-Christiana Hospital	Newark	Delaware	United States	19718
28	Christiana Care Health System-Wilmington Hospital	Wilmington	Delaware	United States	19801
29	MedStar Washington Hospital Center	Washington	District of Columbia	United States	20010
30	George Washington University Medical Center	Washington	District of Columbia	United States	20037
31	Mount Sinai Comprehensive Cancer Center at Aventura	Aventura	Florida	United States	33180
32	University of Florida Health Science Center - Gainesville	Gainesville	Florida	United States	32610
33	Mount Sinai Medical Center	Miami Beach	Florida	United States	33140
34	Indian River Medical Center	Vero Beach	Florida	United States	32960
35	Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia	United States	30322
36	Atlanta VA Medical Center	Decatur	Georgia	United States	30033
37	Lewis Cancer and Research Pavilion at Saint Joseph's/Candler	Savannah	Georgia	United States	31405
38	Pali Momi Medical Center	'Aiea	Hawaii	United States	96701
39	Hawaii Cancer Care Inc - Waterfront Plaza	Honolulu	Hawaii	United States	96813
40	Island Urology	Honolulu	Hawaii	United States	96813
41	Queen's Cancer Cenrer - POB I	Honolulu	Hawaii	United States	96813
42	Queen's Medical Center	Honolulu	Hawaii	United States	96813
43	Straub Clinic and Hospital	Honolulu	Hawaii	United States	96813
44	University of Hawaii Cancer Center	Honolulu	Hawaii	United States	96813
45	Queen's Cancer Center - Kuakini	Honolulu	Hawaii	United States	96817
46	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii	United States	96826
47	Saint Alphonsus Cancer Care Center-Boise	Boise	Idaho	United States	83706
48	Saint Luke's Cancer Institute - Boise	Boise	Idaho	United States	83712
49	Saint Alphonsus Cancer Care Center-Caldwell	Caldwell	Idaho	United States	83605
50	Walter Knox Memorial Hospital	Emmett	Idaho	United States	83617
51	Idaho Urologic Institute-Meridian	Meridian	Idaho	United States	83642
52	Saint Luke's Cancer Institute - Meridian	Meridian	Idaho	United States	83642
53	Saint Alphonsus Medical Center-Nampa	Nampa	Idaho	United States	83686
54	Saint Luke's Cancer Institute - Twin Falls	Twin Falls	Idaho	United States	83301
55	Rush - Copley Medical Center	Aurora	Illinois	United States	60504
56	Illinois CancerCare-Bloomington	Bloomington	Illinois	United States	61704
57	Illinois CancerCare-Canton	Canton	Illinois	United States	61520
58	Illinois CancerCare-Carthage	Carthage	Illinois	United States	62321
59	Centralia Oncology Clinic	Centralia	Illinois	United States	62801
60	Northwestern University	Chicago	Illinois	United States	60611
61	Carle on Vermilion	Danville	Illinois	United States	61832
62	Cancer Care Specialists of Illinois - Decatur	Decatur	Illinois	United States	62526
63	Decatur Memorial Hospital	Decatur	Illinois	United States	62526
64	Carle Physician Group-Effingham	Effingham	Illinois	United States	62401
65	Crossroads Cancer Center	Effingham	Illinois	United States	62401
66	Elmhurst Memorial Hospital	Elmhurst	Illinois	United States	60126
67	Illinois CancerCare-Eureka	Eureka	Illinois	United States	61530
68	Illinois CancerCare-Galesburg	Galesburg	Illinois	United States	61401
69	Edward Hines Jr VA Hospital	Hines	Illinois	United States	60141
70	Illinois CancerCare-Kewanee Clinic	Kewanee	Illinois	United States	61443
71	Illinois CancerCare-Macomb	Macomb	Illinois	United States	61455
72	Carle Physician Group-Mattoon/Charleston	Mattoon	Illinois	United States	61938
73	Loyola University Medical Center	Maywood	Illinois	United States	60153
74	Good Samaritan Regional Health Center	Mount Vernon	Illinois	United States	62864
75	Edward Hospital/Cancer Center	Naperville	Illinois	United States	60540
76	Illinois CancerCare-Ottawa Clinic	Ottawa	Illinois	United States	61350
77	Illinois CancerCare-Pekin	Pekin	Illinois	United States	61554
78	Illinois CancerCare-Peoria	Peoria	Illinois	United States	61615
79	Methodist Medical Center of Illinois	Peoria	Illinois	United States	61636
80	OSF Saint Francis Medical Center	Peoria	Illinois	United States	61637
81	Illinois CancerCare-Peru	Peru	Illinois	United States	61354
82	Edward Hospital/Cancer Center?Plainfield	Plainfield	Illinois	United States	60585
83	Illinois CancerCare-Princeton	Princeton	Illinois	United States	61356
84	Southern Illinois University School of Medicine	Springfield	Illinois	United States	62702
85	Springfield Clinic	Springfield	Illinois	United States	62702
86	Memorial Medical Center	Springfield	Illinois	United States	62781
87	Carle Cancer Center	Urbana	Illinois	United States	61801
88	The Carle Foundation Hospital	Urbana	Illinois	United States	61801
89	Rush-Copley Healthcare Center	Yorkville	Illinois	United States	60560
90	Indiana University/Melvin and Bren Simon Cancer Center	Indianapolis	Indiana	United States	46202
91	Community Cancer Center East	Indianapolis	Indiana	United States	46219
92	Community Cancer Center South	Indianapolis	Indiana	United States	46227
93	Community Cancer Center North	Indianapolis	Indiana	United States	46256
94	Community Howard Regional Health	Kokomo	Indiana	United States	46904
95	Reid Health	Richmond	Indiana	United States	47374
96	Cancer Center of Kansas - Chanute	Chanute	Kansas	United States	66720
97	Cancer Center of Kansas - Dodge City	Dodge City	Kansas	United States	67801
98	Cancer Center of Kansas - El Dorado	El Dorado	Kansas	United States	67042
99	Cancer Center of Kansas - Fort Scott	Fort Scott	Kansas	United States	66701
100	HaysMed University of Kansas Health System	Hays	Kansas	United States	67601
101	Cancer Center of Kansas-Independence	Independence	Kansas	United States	67301
102	University of Kansas Cancer Center	Kansas City	Kansas	United States	66160
103	Cancer Center of Kansas-Kingman	Kingman	Kansas	United States	67068
104	Lawrence Memorial Hospital	Lawrence	Kansas	United States	66044
105	Cancer Center of Kansas-Liberal	Liberal	Kansas	United States	67905
106	Cancer Center of Kansas-Manhattan	Manhattan	Kansas	United States	66502
107	Cancer Center of Kansas - McPherson	McPherson	Kansas	United States	67460
108	Cancer Center of Kansas - Newton	Newton	Kansas	United States	67114
109	Olathe Health Cancer Center	Olathe	Kansas	United States	66061
110	Cancer Center of Kansas - Parsons	Parsons	Kansas	United States	67357
111	Ascension Via Christi - Pittsburg	Pittsburg	Kansas	United States	66762
112	Cancer Center of Kansas - Pratt	Pratt	Kansas	United States	67124
113	Cancer Center of Kansas - Salina	Salina	Kansas	United States	67401
114	Salina Regional Health Center	Salina	Kansas	United States	67401
115	University of Kansas Health System Saint Francis Campus	Topeka	Kansas	United States	66606
116	Cancer Center of Kansas - Wellington	Wellington	Kansas	United States	67152
117	University of Kansas Hospital-Westwood Cancer Center	Westwood	Kansas	United States	66205
118	Cancer Center of Kansas-Wichita Medical Arts Tower	Wichita	Kansas	United States	67208
119	Ascension Via Christi Hospitals Wichita	Wichita	Kansas	United States	67214
120	Cancer Center of Kansas - Wichita	Wichita	Kansas	United States	67214
121	Cancer Center of Kansas - Winfield	Winfield	Kansas	United States	67156
122	University of Kentucky/Markey Cancer Center	Lexington	Kentucky	United States	40536
123	East Jefferson General Hospital	Metairie	Louisiana	United States	70006
124	LSU Healthcare Network / Metairie Multi-Specialty Clinic	Metairie	Louisiana	United States	70006
125	Louisiana State University Health Science Center	New Orleans	Louisiana	United States	70112
126	LSU Health Sciences Center at Shreveport	Shreveport	Louisiana	United States	71103
127	Johns Hopkins University/Sidney Kimmel Cancer Center	Baltimore	Maryland	United States	21287
128	Boston Medical Center	Boston	Massachusetts	United States	02118
129	Lowell General Hospital	Lowell	Massachusetts	United States	01854
130	Saint Joseph Mercy Hospital	Ann Arbor	Michigan	United States	48106
131	Saint Joseph Mercy Brighton	Brighton	Michigan	United States	48114
132	Trinity Health IHA Medical Group Hematology Oncology - Brighton	Brighton	Michigan	United States	48114
133	Saint Joseph Mercy Canton	Canton	Michigan	United States	48188
134	Trinity Health IHA Medical Group Hematology Oncology - Canton	Canton	Michigan	United States	48188
135	Caro Cancer Center	Caro	Michigan	United States	48723
136	Saint Joseph Mercy Chelsea	Chelsea	Michigan	United States	48118
137	Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital	Chelsea	Michigan	United States	48118
138	Hematology Oncology Consultants-Clarkston	Clarkston	Michigan	United States	48346
139	Newland Medical Associates-Clarkston	Clarkston	Michigan	United States	48346
140	Michigan State University Clinical Center	East Lansing	Michigan	United States	48824-7016
141	Genesee Cancer and Blood Disease Treatment Center	Flint	Michigan	United States	48503
142	Genesee Hematology Oncology PC	Flint	Michigan	United States	48503
143	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
144	Sparrow Hospital	Lansing	Michigan	United States	48912
145	Saint Mary's Oncology/Hematology Associates of Marlette	Marlette	Michigan	United States	48453
146	Newland Medical Associates-Pontiac	Pontiac	Michigan	United States	48341
147	Saint Joseph Mercy Oakland	Pontiac	Michigan	United States	48341
148	Ascension Saint Mary's Hospital	Saginaw	Michigan	United States	48601
149	Oncology Hematology Associates of Saginaw Valley PC	Saginaw	Michigan	United States	48604
150	Saint Mary's Oncology/Hematology Associates of West Branch	West Branch	Michigan	United States	48661
151	Huron Gastroenterology PC	Ypsilanti	Michigan	United States	48106
152	Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus	Ypsilanti	Michigan	United States	48197
153	Fairview Ridges Hospital	Burnsville	Minnesota	United States	55337
154	Essentia Health - Deer River Clinic	Deer River	Minnesota	United States	56636
155	Essentia Health Cancer Center	Duluth	Minnesota	United States	55805
156	Essentia Health Saint Mary's Medical Center	Duluth	Minnesota	United States	55805
157	Miller-Dwan Hospital	Duluth	Minnesota	United States	55805
158	Saint Luke's Hospital of Duluth	Duluth	Minnesota	United States	55805
159	Fairview Southdale Hospital	Edina	Minnesota	United States	55435
160	Essentia Health Hibbing Clinic	Hibbing	Minnesota	United States	55746
161	Coborn Cancer Center at Saint Cloud Hospital	Saint Cloud	Minnesota	United States	56303
162	Saint Cloud Hospital	Saint Cloud	Minnesota	United States	56303
163	Park Nicollet Clinic - Saint Louis Park	Saint Louis Park	Minnesota	United States	55416
164	Essentia Health Virginia Clinic	Virginia	Minnesota	United States	55792
165	Fairview Lakes Medical Center	Wyoming	Minnesota	United States	55092
166	Parkland Health Center-Bonne Terre	Bonne Terre	Missouri	United States	63628
167	Saint Francis Medical Center	Cape Girardeau	Missouri	United States	63703
168	Southeast Cancer Center	Cape Girardeau	Missouri	United States	63703
169	University of Missouri - Ellis Fischel	Columbia	Missouri	United States	65212
170	Kansas City Veterans Affairs Medical Center	Kansas City	Missouri	United States	64128
171	Missouri Baptist Medical Center	Saint Louis	Missouri	United States	63131
172	Sainte Genevieve County Memorial Hospital	Sainte Genevieve	Missouri	United States	63670
173	Missouri Baptist Sullivan Hospital	Sullivan	Missouri	United States	63080
174	Missouri Baptist Outpatient Center-Sunset Hills	Sunset Hills	Missouri	United States	63127
175	Benefis Healthcare- Sletten Cancer Institute	Great Falls	Montana	United States	59405
176	Saint Patrick Hospital - Community Hospital	Missoula	Montana	United States	59802
177	Nebraska Medicine-Village Pointe	Omaha	Nebraska	United States	68118
178	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198
179	Cancer and Blood Specialists-Henderson	Henderson	Nevada	United States	89052
180	Ann M Wierman MD LTD	Las Vegas	Nevada	United States	89128
181	Comprehensive Cancer Centers of Nevada - Northwest	Las Vegas	Nevada	United States	89128
182	OptumCare Cancer Care at MountainView	Las Vegas	Nevada	United States	89128
183	Comprehensive Cancer Centers of Nevada - Town Center	Las Vegas	Nevada	United States	89144
184	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada	United States	89148
185	Comprehensive Cancer Centers of Nevada - Central Valley	Las Vegas	Nevada	United States	89169
186	Renown Regional Medical Center	Reno	Nevada	United States	89502
187	Robert Wood Johnson University Hospital Somerset	Somerville	New Jersey	United States	08876
188	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
189	Mount Sinai West	New York	New York	United States	10019
190	NYP/Weill Cornell Medical Center	New York	New York	United States	10065
191	University of Rochester	Rochester	New York	United States	14642
192	State University of New York Upstate Medical University	Syracuse	New York	United States	13210
193	Southeastern Medical Oncology Center-Clinton	Clinton	North Carolina	United States	28328
194	Southeastern Medical Oncology Center-Goldsboro	Goldsboro	North Carolina	United States	27534
195	Wayne Memorial Hospital	Goldsboro	North Carolina	United States	27534
196	Southeastern Medical Oncology Center-Jacksonville	Jacksonville	North Carolina	United States	28546
197	WG Hefner VA Medical Center	Salisbury	North Carolina	United States	28144
198	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157
199	Sanford Bismarck Medical Center	Bismarck	North Dakota	United States	58501
200	Sanford Broadway Medical Center	Fargo	North Dakota	United States	58122
201	Sanford Roger Maris Cancer Center	Fargo	North Dakota	United States	58122
202	Dayton Physician LLC-Miami Valley Hospital North	Dayton	Ohio	United States	45415
203	Miami Valley Hospital North	Dayton	Ohio	United States	45415
204	Kettering Medical Center	Kettering	Ohio	United States	45429
205	Saint Rita's Medical Center	Lima	Ohio	United States	45801
206	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
207	Mercy Hospital Oklahoma City	Oklahoma City	Oklahoma	United States	73120
208	Oklahoma Cancer Specialists and Research Institute-Tulsa	Tulsa	Oklahoma	United States	74146
209	Saint Alphonsus Medical Center-Baker City	Baker City	Oregon	United States	97814
210	Legacy Mount Hood Medical Center	Gresham	Oregon	United States	97030
211	Saint Alphonsus Medical Center-Ontario	Ontario	Oregon	United States	97914
212	Legacy Good Samaritan Hospital and Medical Center	Portland	Oregon	United States	97210
213	Legacy Meridian Park Hospital	Tualatin	Oregon	United States	97062
214	Christiana Care Health System-Concord Health Center	Chadds Ford	Pennsylvania	United States	19317
215	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
216	Prisma Health Cancer Institute - Spartanburg	Boiling Springs	South Carolina	United States	29316
217	Prisma Health Cancer Institute - Laurens	Clinton	South Carolina	United States	29325
218	Prisma Health Cancer Institute - Easley	Easley	South Carolina	United States	29640
219	Prisma Health Cancer Institute - Butternut	Greenville	South Carolina	United States	29605
220	Prisma Health Cancer Institute - Faris	Greenville	South Carolina	United States	29605
221	Prisma Health Greenville Memorial Hospital	Greenville	South Carolina	United States	29605
222	Prisma Health Cancer Institute - Eastside	Greenville	South Carolina	United States	29615
223	Prisma Health Cancer Institute - Greer	Greer	South Carolina	United States	29650
224	Prisma Health Cancer Institute - Seneca	Seneca	South Carolina	United States	29672
225	Sanford Cancer Center Oncology Clinic	Sioux Falls	South Dakota	United States	57104
226	Sanford USD Medical Center - Sioux Falls	Sioux Falls	South Dakota	United States	57117-5134
227	University of Texas Medical Branch	Galveston	Texas	United States	77555-0565
228	Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center	Houston	Texas	United States	77030
229	UTMB Cancer Center at Victory Lakes	League City	Texas	United States	77573
230	Audie L Murphy VA Hospital	San Antonio	Texas	United States	78229
231	University Hospital	San Antonio	Texas	United States	78229
232	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229
233	Farmington Health Center	Farmington	Utah	United States	84025
234	Huntsman Cancer Institute/University of Utah	Salt Lake City	Utah	United States	84112
235	South Jordan Health Center	South Jordan	Utah	United States	84009
236	Centra Lynchburg Hematology-Oncology Clinic Inc	Lynchburg	Virginia	United States	24501
237	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia	United States	23298
238	Swedish Medical Center-First Hill	Seattle	Washington	United States	98122-4307
239	Legacy Salmon Creek Hospital	Vancouver	Washington	United States	98686
240	West Virginia University Charleston Division	Charleston	West Virginia	United States	25304
241	Duluth Clinic Ashland	Ashland	Wisconsin	United States	54806
242	Aurora Cancer Care-Southern Lakes VLCC	Burlington	Wisconsin	United States	53105
243	Marshfield Clinic-Chippewa Center	Chippewa Falls	Wisconsin	United States	54729
244	Marshfield Medical Center-EC Cancer Center	Eau Claire	Wisconsin	United States	54701
245	Aurora Health Center-Fond du Lac	Fond Du Lac	Wisconsin	United States	54937
246	Aurora Health Care Germantown Health Center	Germantown	Wisconsin	United States	53022
247	Aurora Cancer Care-Grafton	Grafton	Wisconsin	United States	53024
248	Aurora BayCare Medical Center	Green Bay	Wisconsin	United States	54311
249	Aurora Cancer Care-Kenosha South	Kenosha	Wisconsin	United States	53142
250	Marshfield Clinic - Ladysmith Center	Ladysmith	Wisconsin	United States	54848
251	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin	United States	53792
252	Aurora Bay Area Medical Group-Marinette	Marinette	Wisconsin	United States	54143
253	Marshfield Medical Center-Marshfield	Marshfield	Wisconsin	United States	54449
254	Aurora Cancer Care-Milwaukee	Milwaukee	Wisconsin	United States	53209
255	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin	United States	53215
256	Aurora Sinai Medical Center	Milwaukee	Wisconsin	United States	53233
257	Marshfield Clinic-Minocqua Center	Minocqua	Wisconsin	United States	54548
258	Vince Lombardi Cancer Clinic - Oshkosh	Oshkosh	Wisconsin	United States	54904
259	Aurora Cancer Care-Racine	Racine	Wisconsin	United States	53406
260	Marshfield Medical Center-Rice Lake	Rice Lake	Wisconsin	United States	54868
261	Vince Lombardi Cancer Clinic-Sheboygan	Sheboygan	Wisconsin	United States	53081
262	Marshfield Medical Center-River Region at Stevens Point	Stevens Point	Wisconsin	United States	54482
263	Aurora Medical Center in Summit	Summit	Wisconsin	United States	53066
264	Vince Lombardi Cancer Clinic-Two Rivers	Two Rivers	Wisconsin	United States	54241
265	Marshfield Clinic-Wausau Center	Wausau	Wisconsin	United States	54401
266	Aurora Cancer Care-Milwaukee West	Wauwatosa	Wisconsin	United States	53226
267	Aurora West Allis Medical Center	West Allis	Wisconsin	United States	53227
268	Marshfield Medical Center - Weston	Weston	Wisconsin	United States	54476
269	Marshfield Clinic - Wisconsin Rapids Center	Wisconsin Rapids	Wisconsin	United States	54494
270	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
271	The Research Institute of the McGill University Health Centre (MUHC)	Montreal	Quebec	Canada	H3H 2R9
272	Allan Blair Cancer Centre	Regina	Saskatchewan	Canada	S4T 7T1

Sponsors and Collaborators

• National Cancer Institute (NCI)
• Canadian Cancer Trials Group

Investigators

• Principal Investigator: Peter C Black, Southwest Oncology Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Cancer Institute (NCI)
• ClinicalTrials.gov Identifier: NCT02844816
• Other Study ID Numbers: NCI-2016-01104; NCI-2016-01104; S1605; S1605; U10CA180888
• First Posted: Jul 26, 2016
• Last Update Posted: Jul 21, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Atezolizumab; Antibodies, Monoclonal

Study Results

No Results Posted as of Jul 21, 2022