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BRIEF TITLE: Trial of Atezolizumab in BCG-Unresponsive Non-muscle Invasive Bladder Cancer

Phase II Trial of Atezolizumab in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer


  • Org Study ID: NCI-2016-01104
  • Secondary ID: NCI-2016-01104,S1605,S1605,U10CA180888
  • NCT ID: NCT02844816
  • NCT Alias:
  • Sponsor: National Cancer Institute (NCI) - NIH
  • Source: 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.

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.

TERTIARY 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: expression of PD-L1
and CD8 by immunohistochemistry (IHC); expression of immune signatures by ribonucleic acid
(RNA)-sequencing (RNA-seq).

OUTLINE:

Patients receive atezolizumab intravenously (IV) over 60 minutes on day 1. Treatment repeats
every 21 days for up to 17 courses (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.

Overal Status Start Date Phase Study Type
Recruiting February 7, 2017 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Complete response (CR) rate in the subset of patients with carcinoma in situ (CIS) based on biopsy

Primary Outcome 1 - Time Frame: At 25 weeks

Primary Outcome 2 - Measure: Event-free survival (EFS)

Primary Outcome 2 - Time Frame: From date of registration to first documentation of event, assessed up to 18 months

Condition:

  • 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

Eligibility

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, 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)

- Patients must have had 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 patients with only Ta/T1 disease 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 must undergo re-transurethral resection of
bladder tumor (TURBT) within 60 days prior to registration, and must have uninvolved
muscularis propria in the pathologic specimen from either the first or the second
TURBT; tissue from the re-resection must be submitted; the TURBT that identified the
recurrent T1 disease may have taken place more than 60 days prior to registration

- Patients must not have had urothelial carcinoma in the prostate or upper urinary tract
within the previous 24 months, or muscle invasive urothelial carcinoma of the bladder
at any time; patients must have a computed tomography (CT) or magnetic resonance
imaging (MRI) of the abdomen and pelvis to rule out upper tract malignancy and
intra-abdominal metastases 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 or second induction BCG (>= 2 doses)

- Patient has high grade T1 urothelial carcinoma after induction BCG (>= 5 doses)
only or after induction BCG (>= 5 doses) and first round maintenance or second
induction BCG (>= 2 doses)

- Patient is disease-free at 6 months after starting BCG (i.e., complete response)
but then experiences a high-grade recurrence within 6 months after the last BCG
dose

- 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 systemic chemotherapy or 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, or vaccine therapies within 6 weeks prior
to cycle 1, day 1; patients must not have received or be planning to receive any of
the prohibited therapies during protocol treatment; prior intravesical interferon
therapy is allowed

- Patients must not be planning to receive concomitant other biologic therapy, radiation
therapy, intravesical chemotherapy, surgery, or other 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 cycle 1, day 1; 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 of a live, attenuated vaccine within 4 weeks before
cycle 1, day 1 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)

- Alkaline phosphatase =< 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
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Peter Black

Role: Principal Investigator

Affiliation: Southwest Oncology Group

Locations

Facility Status Contact
Southern Cancer Center PC-Daphne
Daphne, Alabama 36526
United States
Recruiting Site Public Contact
251-607-5281
sue.deoliveira@southerncancercenter.com
Southern Cancer Center PC-Mobile
Mobile, Alabama 36607
United States
Recruiting Site Public Contact
251-607-5281
sue.deoliveira@southerncancercenter.com
Southern Cancer Center PC-Providence
Mobile, Alabama 36608
United States
Recruiting Site Public Contact
251-607-5281
sue.deoliveira@southerncancercenter.com
Southern Cancer Center PC-Springhill
Mobile, Alabama 36608
United States
Recruiting Site Public Contact
251-607-5281
sue.deoliveira@southerncancercenter.com
Mayo Clinic in Arizona
Scottsdale, Arizona 85259
United States
Recruiting Site Public Contact
855-776-0015
Veteran's Administration Medical Center
Little Rock, Arkansas 72205
United States
Recruiting Site Public Contact

protocols@swog.org
UC San Diego Moores Cancer Center
La Jolla, California 92093
United States
Recruiting Site Public Contact
858-822-5354
cancercto@ucsd.edu
Los Angeles County-USC Medical Center
Los Angeles, California 90033
United States
Recruiting Site Public Contact
323-865-0451
USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Recruiting Site Public Contact
323-865-0451
Stanford Cancer Institute Palo Alto
Palo Alto, California 94304
United States
Recruiting Site Public Contact
650-498-7061
ccto-office@stanford.edu
Eisenhower Medical Center
Rancho Mirage, California 92270
United States
Recruiting Site Public Contact
760-834-3798
University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
Recruiting Site Public Contact
916-734-3089
UCSF Medical Center-Mission Bay
San Francisco, California 94158
United States
Recruiting Site Public Contact
877-827-3222
University of Colorado Hospital
Aurora, Colorado 80045
United States
Recruiting Site Public Contact
720-848-0650
Kaiser Permanente-Franklin
Denver, Colorado 80205
United States
Recruiting Site Public Contact
303-764-5056
josh.b.gordon@nsmtp.kp.org
Kaiser Permanente-Rock Creek
Lafayette, Colorado 80026
United States
Recruiting Site Public Contact
303-764-5056
josh.b.gordon@nsmtp.kp.org
Kaiser Permanente-Lone Tree
Lone Tree, Colorado 80124
United States
Recruiting Site Public Contact
303-764-5056
josh.b.gordon@nsmtp.kp.org
Greenwich Hospital
Greenwich, Connecticut 06830
United States
Recruiting Site Public Contact
203-863-3698
Yale University
New Haven, Connecticut 06520
United States
Recruiting Site Public Contact
203-785-5702
canceranswers@yale.edu
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware 19713
United States
Suspended
Helen F Graham Cancer Center
Newark, Delaware 19713
United States
Recruiting Site Public Contact
302-623-4450
KDempsey@christianacare.org
Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
United States
Recruiting Site Public Contact
302-623-4450
KDempsey@christianacare.org
Regional Hematology and Oncology PA
Newark, Delaware 19713
United States
Suspended
Christiana Care Health System-Christiana Hospital
Newark, Delaware 19718
United States
Suspended
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware 19801
United States
Suspended
George Washington University Medical Center
Washington, District of Columbia 20037
United States
Suspended
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida 33180
United States
Suspended
University of Florida Health Science Center - Gainesville
Gainesville, Florida 32610
United States
Recruiting Site Public Contact

protocols@swog.org
Mount Sinai Medical Center
Miami Beach, Florida 33140
United States
Recruiting Site Public Contact
305-674-2625
info@msccop.com
Indian River Medical Center
Vero Beach, Florida 32960
United States
Recruiting Site Public Contact
772-563-4673
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
United States
Recruiting Site Public Contact
404-778-1868
Atlanta VA Medical Center
Decatur, Georgia 30033
United States
Suspended
Pali Momi Medical Center
'Aiea, Hawaii 96701
United States
Recruiting Site Public Contact
808-486-6000
Hawaii Cancer Care Inc-POB II
Honolulu, Hawaii 96813
United States
Recruiting Site Public Contact
808-524-6115
Hawaii Oncology Inc-POB I
Honolulu, Hawaii 96813
United States
Suspended
Island Urology
Honolulu, Hawaii 96813
United States
Suspended
Queen's Medical Center
Honolulu, Hawaii 96813
United States
Recruiting Site Public Contact

protocols@swog.org
Straub Clinic and Hospital
Honolulu, Hawaii 96813
United States
Recruiting Site Public Contact
808-522-4333
University of Hawaii Cancer Center
Honolulu, Hawaii 96813
United States
Suspended
Hawaii Oncology Inc-Kuakini
Honolulu, Hawaii 96817
United States
Recruiting Site Public Contact
808-531-8521
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii 96826
United States
Suspended
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706
United States
Suspended
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605
United States
Suspended
Walter Knox Memorial Hospital
Emmett, Idaho 83617
United States
Suspended
Idaho Urologic Institute-Meridian
Meridian, Idaho 83642
United States
Suspended
Saint Alphonsus Medical Center-Nampa
Nampa, Idaho 83686
United States
Suspended
Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
United States
Recruiting Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Illinois CancerCare-Canton
Canton, Illinois 61520
United States
Recruiting Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Illinois CancerCare-Carthage
Carthage, Illinois 62321
United States
Recruiting Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Centralia Oncology Clinic
Centralia, Illinois 62801
United States
Suspended
Northwestern University
Chicago, Illinois 60611
United States
Recruiting Site Public Contact
312-695-1301
cancer@northwestern.edu
Carle on Vermilion
Danville, Illinois 61832
United States
Recruiting Site Public Contact
800-446-5532
Research@carle.com
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
United States
Recruiting Site Public Contact
217-876-4740
rhamrick@dmhhs.org
Decatur Memorial Hospital
Decatur, Illinois 62526
United States
Suspended
Carle Physician Group-Effingham
Effingham, Illinois 62401
United States
Recruiting Site Public Contact
800-446-5532
Research@carle.com
Crossroads Cancer Center
Effingham, Illinois 62401
United States
Recruiting Site Public Contact
217-876-4740
rhamrick@dmhhs.org
Elmhurst Memorial Hospital
Elmhurst, Illinois 60126
United States
Active, not recruiting
Illinois CancerCare-Eureka
Eureka, Illinois 61530
United States
Recruiting Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
United States
Recruiting Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Hines Veterans Administration Hospital
Hines, Illinois 60141
United States
Suspended
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
United States
Recruiting Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Illinois CancerCare-Macomb
Macomb, Illinois 61455
United States
Recruiting Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
United States
Recruiting Site Public Contact
800-446-5532
Research@carle.com
Loyola University Medical Center
Maywood, Illinois 60153
United States
Recruiting Site Public Contact
708-226-4357
Edward Hospital/Cancer Center
Naperville, Illinois 60540
United States
Active, not recruiting
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
United States
Recruiting Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Illinois CancerCare-Pekin
Pekin, Illinois 61554
United States
Recruiting Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Illinois CancerCare-Peoria
Peoria, Illinois 61615
United States
Recruiting Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Methodist Medical Center of Illinois
Peoria, Illinois 61636
United States
Suspended
OSF Saint Francis Medical Center
Peoria, Illinois 61637
United States
Suspended
Illinois CancerCare-Peru
Peru, Illinois 61354
United States
Recruiting Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Edward Hospital/Cancer Center?Plainfield
Plainfield, Illinois 60585
United States
Active, not recruiting
Illinois CancerCare-Princeton
Princeton, Illinois 61356
United States
Recruiting Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com
Southern Illinois University School of Medicine
Springfield, Illinois 62702
United States
Recruiting Site Public Contact
217-545-7929
Springfield Clinic
Springfield, Illinois 62702
United States
Recruiting Site Public Contact
800-444-7541
Memorial Medical Center
Springfield, Illinois 62781
United States
Suspended
Carle Cancer Center
Urbana, Illinois 61801
United States
Recruiting Site Public Contact
800-446-5532
Research@carle.com
The Carle Foundation Hospital
Urbana, Illinois 61801
United States
Recruiting Site Public Contact
800-446-5532
Research@carle.com
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
United States
Recruiting Site Public Contact
317-278-5632
iutrials@iu.edu
Community Cancer Center East
Indianapolis, Indiana 46219
United States
Recruiting Site Public Contact
317-497-2823
lcheri@ecommunity.com
Community Cancer Center South
Indianapolis, Indiana 46227
United States
Recruiting Site Public Contact
317-497-2823
lcheri@ecommunity.com
Community Cancer Center North
Indianapolis, Indiana 46256
United States
Recruiting Site Public Contact
317-497-2823
lcheri@ecommunity.com
Community Howard Regional Health
Kokomo, Indiana 46904
United States
Recruiting Site Public Contact
765-453-8571
oncology@communityhoward.org
Reid Health
Richmond, Indiana 47374
United States
Recruiting Site Public Contact
937-775-1350
som_dcop@wright.edu
Cancer Center of Kansas - Chanute
Chanute, Kansas 66720
United States
Suspended
Cancer Center of Kansas - Dodge City
Dodge City, Kansas 67801
United States
Suspended
Cancer Center of Kansas - El Dorado
El Dorado, Kansas 67042
United States
Suspended
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas 66701
United States
Suspended
Hays Medical Center
Hays, Kansas 67601
United States
Recruiting Site Public Contact
785-623-5774
Cancer Center of Kansas-Independence
Independence, Kansas 67301
United States
Suspended
University of Kansas Cancer Center
Kansas City, Kansas 66160
United States
Recruiting Site Public Contact
913-945-7552
ctnursenav@kumc.edu
Cancer Center of Kansas-Kingman
Kingman, Kansas 67068
United States
Suspended
Lawrence Memorial Hospital
Lawrence, Kansas 66044
United States
Recruiting Site Public Contact
316-268-5374
Keisha.humphries@ascension.org
Cancer Center of Kansas-Liberal
Liberal, Kansas 67905
United States
Suspended
Cancer Center of Kansas-Manhattan
Manhattan, Kansas 66502
United States
Suspended
Cancer Center of Kansas - McPherson
McPherson, Kansas 67460
United States
Suspended
Cancer Center of Kansas - Newton
Newton, Kansas 67114
United States
Suspended
Cancer Center of Kansas - Parsons
Parsons, Kansas 67357
United States
Suspended
Cancer Center of Kansas - Pratt
Pratt, Kansas 67124
United States
Suspended
Cancer Center of Kansas - Salina
Salina, Kansas 67401
United States
Suspended
Salina Regional Health Center
Salina, Kansas 67401
United States
Recruiting Site Public Contact
785-452-7038
kkavoura@srhc.com
Saint Francis Hospital and Medical Center - Topeka
Topeka, Kansas 66606
United States
Recruiting Site Public Contact
785-295-8000
Cancer Center of Kansas - Wellington
Wellington, Kansas 67152
United States
Suspended
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
United States
Recruiting Site Public Contact
913-945-7552
ctnursenav@kumc.edu
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas 67208
United States
Recruiting Site Public Contact
316-268-5374
Keisha.humphries@ascension.org
Cancer Center of Kansas - Wichita
Wichita, Kansas 67214
United States
Recruiting Site Public Contact
316-268-5374
Keisha.humphries@ascension.org
Via Christi Regional Medical Center
Wichita, Kansas 67214
United States
Suspended
Cancer Center of Kansas - Winfield
Winfield, Kansas 67156
United States
Suspended
University of Kentucky/Markey Cancer Center
Lexington, Kentucky 40536
United States
Recruiting Site Public Contact
859-257-3379
East Jefferson General Hospital
Metairie, Louisiana 70006
United States
Recruiting Site Public Contact
504-210-3539
trials@jeffradonc.com
Louisiana State University Health Science Center
New Orleans, Louisiana 70112
United States
Suspended
Louisiana State University Health Sciences Center Shreveport
Shreveport, Louisiana 71103
United States
Recruiting Site Public Contact
318-813-1412
JRowel@lsuhsc.edu
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland 21287
United States
Suspended
Boston Medical Center
Boston, Massachusetts 02118
United States
Suspended
Lowell General Hospital
Lowell, Massachusetts 01854
United States
Recruiting Site Public Contact
978-788-7084
ghincks@lowellgeneral.org
Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
IHA Hematology Oncology Consultants-Brighton
Brighton, Michigan 48114
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Saint Joseph Mercy Brighton
Brighton, Michigan 48114
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
IHA Hematology Oncology Consultants-Canton
Canton, Michigan 48188
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Saint Joseph Mercy Canton
Canton, Michigan 48188
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Caro Cancer Center
Caro, Michigan 48723
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
IHA Hematology Oncology Consultants-Chelsea
Chelsea, Michigan 48118
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Saint Joseph Mercy Chelsea
Chelsea, Michigan 48118
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan 48346
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Newland Medical Associates-Clarkston
Clarkston, Michigan 48346
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Michigan State University Clinical Center
East Lansing, Michigan 48824-7016
United States
Recruiting Site Public Contact
517-975-9547
Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan 48503
United States
Suspended
Genesee Hematology Oncology PC
Flint, Michigan 48503
United States
Suspended
Genesys Hurley Cancer Institute
Flint, Michigan 48503
United States
Suspended
Sparrow Hospital
Lansing, Michigan 48912
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan 48453
United States
Recruiting Site Public Contact
989-343-2487
Newland Medical Associates-Pontiac
Pontiac, Michigan 48341
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Saint Joseph Mercy Oakland
Pontiac, Michigan 48341
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Saint Mary's of Michigan
Saginaw, Michigan 48601
United States
Recruiting Site Public Contact

protocols@swog.org
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan 48604
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan 48661
United States
Recruiting Site Public Contact
989-343-2487
Huron Gastroenterology PC
Ypsilanti, Michigan 48106
United States
Suspended
IHA Hematology Oncology Consultants-Ann Arbor
Ypsilanti, Michigan 48197
United States
Recruiting Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Fairview Ridges Hospital
Burnsville, Minnesota 55337
United States
Suspended
Essentia Health Cancer Center
Duluth, Minnesota 55805
United States
Recruiting Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota 55805
United States
Suspended
Miller-Dwan Hospital
Duluth, Minnesota 55805
United States
Suspended
Saint Luke's Hospital of Duluth
Duluth, Minnesota 55805
United States
Recruiting Site Public Contact
888-823-5923
ctsucontact@westat.com
Fairview-Southdale Hospital
Edina, Minnesota 55435
United States
Recruiting Site Public Contact
952-993-1517
mmcorc@healthpartners.com
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota 56303
United States
Recruiting Site Public Contact
877-229-4907
coborncancercenter@centracare.com
Saint Cloud Hospital
Saint Cloud, Minnesota 56303
United States
Suspended
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
United States
Suspended
Fairview Lakes Medical Center
Wyoming, Minnesota 55092
United States
Recruiting Site Public Contact
952-993-1517
mmcorc@healthpartners.com
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri 63628
United States
Recruiting Site Public Contact
314-996-5569
Saint Francis Medical Center
Cape Girardeau, Missouri 63703
United States
Recruiting Site Public Contact
573-334-2230
sfmc@sfmc.net
Southeast Cancer Center
Cape Girardeau, Missouri 63703
United States
Recruiting Site Public Contact
573-651-5550
University of Missouri - Ellis Fischel
Columbia, Missouri 65212
United States
Recruiting Site Public Contact
573-882-7440
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri 64128
United States
Suspended
Missouri Baptist Medical Center
Saint Louis, Missouri 63131
United States
Recruiting Site Public Contact
314-996-5569
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
United States
Recruiting Site Public Contact
314-996-5569
Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
United States
Recruiting Site Public Contact
314-996-5569
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri 63127
United States
Recruiting Site Public Contact
314-996-5569
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana 59405
United States
Recruiting Site Public Contact
406-969-6060
mccinfo@mtcancer.org
Cancer and Blood Specialists-Henderson
Henderson, Nevada 89052
United States
Suspended
Ann M Wierman MD LTD
Las Vegas, Nevada 89128
United States
Suspended
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada 89128
United States
Suspended
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89148
United States
Suspended
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada 89169
United States
Recruiting Site Public Contact
702-384-0013
research@sncrf.org
Renown Regional Medical Center
Reno, Nevada 89502
United States
Suspended
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Recruiting Site Public Contact
800-767-9355
askroswell@roswellpark.org
Mount Sinai West
New York, New York 10019
United States
Recruiting Site Public Contact
212-824-7309
CCTO@mssm.edu
Weill Medical College of Cornell University
New York, New York 10065
United States
Recruiting Site Public Contact
212-746-1848
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina 28328
United States
Recruiting Site Public Contact
919-587-9077
ecooke@cancersmoc.com
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina 27534
United States
Recruiting Site Public Contact
919-587-9077
ecooke@cancersmoc.com
Wayne Memorial Hospital
Goldsboro, North Carolina 27534
United States
Suspended
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina 28546
United States
Recruiting Site Public Contact
910-353-0824
ecooke@cancersmoc.com
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
United States
Recruiting Site Public Contact
336-713-6771
Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
United States
Recruiting Site Public Contact
701-323-5760
tamara.fischer@sanfordhealth.org
Roger Maris Cancer Center
Fargo, North Dakota 58122
United States
Recruiting Site Public Contact
701-234-6161
Sanford Broadway Medical Center
Fargo, North Dakota 58122
United States
Recruiting Site Public Contact
800-437-4010
Dayton Physicians LLC-Samaritan North
Dayton, Ohio 45415
United States
Recruiting Site Public Contact
937-775-1350
som_dcop@wright.edu
Miami Valley Hospital North
Dayton, Ohio 45415
United States
Recruiting Site Public Contact
937-775-1350
som_dcop@wright.edu
Saint Rita's Medical Center
Lima, Ohio 45801
United States
Recruiting Site Public Contact
888-823-5923
ctsucontact@westat.com
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Recruiting Site Public Contact
405-271-8777
ou-clinical-trials@ouhsc.edu
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma 73120
United States
Suspended
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma 74146
United States
Recruiting Site Public Contact
918-505-3200
Saint Alphonsus Medical Center-Baker City
Baker City, Oregon 97814
United States
Suspended
Legacy Mount Hood Medical Center
Gresham, Oregon 97030
United States
Suspended
Saint Alphonsus Medical Center-Ontario
Ontario, Oregon 97914
United States
Suspended
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon 97210
United States
Recruiting Site Public Contact
800-220-4937
cancer@lhs.org
Legacy Meridian Park Hospital
Tualatin, Oregon 97062
United States
Suspended
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania 19317
United States
Suspended
Greenville Health System Cancer Institute-Laurens
Clinton, South Carolina 29325
United States
Suspended
Greenville Health System Cancer Institute-Easley
Easley, South Carolina 29640
United States
Recruiting Site Public Contact
864-241-6251
kwilliams8@ghs.org
Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina 29605
United States
Recruiting Site Public Contact
864-241-6251
kwilliams8@ghs.org
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina 29605
United States
Recruiting Site Public Contact
864-241-6251
kwilliams8@ghs.org
Greenville Memorial Hospital
Greenville, South Carolina 29605
United States
Suspended
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina 29615
United States
Recruiting Site Public Contact
864-241-6251
kwilliams8@ghs.org
Greenville Health System Cancer Institute-Greer
Greer, South Carolina 29650
United States
Recruiting Site Public Contact
864-241-6251
kwilliams8@ghs.org
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina 29672
United States
Recruiting Site Public Contact
864-241-6251
kwilliams8@ghs.org
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina 29307
United States
Recruiting Site Public Contact
864-241-6251
kwilliams8@ghs.org
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
United States
Recruiting Site Public Contact
605-312-3320
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
United States
Recruiting Site Public Contact
605-312-3320
OncologyClinicalTrialsSF@SanfordHealth.org
University of Texas Medical Branch
Galveston, Texas 77555-0565
United States
Recruiting Site Public Contact
409-772-1950
clinical.research@utmb.edu
UTMB Cancer Center at Victory Lakes
League City, Texas 77573
United States
Suspended
Audie L Murphy Veterans Affairs Hospital
San Antonio, Texas 78209
United States
Recruiting Site Public Contact
877-469-5300
University Hospital
San Antonio, Texas 78229
United States
Active, not recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United States
Recruiting Site Public Contact
210-450-3800
phoresearchoffice@uthscsa.edu
Farmington Health Center
Farmington, Utah 84025
United States
Suspended
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
United States
Recruiting Site Public Contact
888-424-2100
cancerinfo@hci.utah.edu
South Jordan Health Center
South Jordan, Utah 84009
United States
Suspended
Centra Lynchburg Hematology-Oncology Clinic Inc
Lynchburg, Virginia 24501
United States
Recruiting Site Public Contact
434-200-5925
Kevin.Patel@centrahealth.com
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia 23298
United States
Recruiting Site Public Contact

mwellons@vcu.edu
Legacy Salmon Creek Hospital
Vancouver, Washington 98686
United States
Recruiting Site Public Contact
503-413-2150
West Virginia University Charleston Division
Charleston, West Virginia 25304
United States
Recruiting Site Public Contact
304-388-9944
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin 53105
United States
Recruiting Site Public Contact
414-302-2304
ncorp@aurora.org
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin 54729
United States
Recruiting Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org
Marshfield Clinic Cancer Center - Eau Claire
Eau Claire, Wisconsin 54701
United States
Recruiting Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org
Aurora Health Center-Fond du Lac
Fond Du Lac, Wisconsin 54937
United States
Recruiting Site Public Contact
414-302-2304
ncorp@aurora.org
Aurora Health Care Germantown Health Center
Germantown, Wisconsin 53022
United States
Recruiting Site Public Contact
414-302-2304
ncorp@aurora.org
Aurora Cancer Care-Grafton
Grafton, Wisconsin 53024
United States
Recruiting Site Public Contact
414-302-2304
ncorp@aurora.org
Aurora BayCare Medical Center
Green Bay, Wisconsin 54311
United States
Recruiting Site Public Contact
414-302-2304
ncorp@aurora.org
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin 53142
United States
Recruiting Site Public Contact
414-302-2304
ncorp@aurora.org
Marshfield Clinic - Ladysmith Center
Ladysmith, Wisconsin 54848
United States
Recruiting Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org
University of Wisconsin Hospital and Clinics
Madison, Wisconsin 53792
United States
Recruiting Site Public Contact
800-622-8922
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin 54143
United States
Recruiting Site Public Contact
414-302-2304
ncorp@aurora.org
Vince Lombardi Cancer Clinic-Marinette
Marinette, Wisconsin 54143
United States
Recruiting Antony Ruggeri
800-252-2990
Marshfield Clinic
Marshfield, Wisconsin 54449
United States
Recruiting Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin 53209
United States
Recruiting Site Public Contact
414-302-2304
ncorp@aurora.org
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin 53215
United States
Recruiting Site Public Contact
888-823-5923
ctsucontact@westat.com
Aurora Sinai Medical Center
Milwaukee, Wisconsin 53233
United States
Recruiting Site Public Contact
414-302-2304
ncorp@aurora.org
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin 54548
United States
Recruiting Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin 54904
United States
Recruiting Site Public Contact
414-302-2304
ncorp@aurora.org
Aurora Cancer Care-Racine
Racine, Wisconsin 53406
United States
Recruiting Site Public Contact
414-302-2304
ncorp@aurora.org
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin 54868
United States
Recruiting Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin 53081
United States
Recruiting Site Public Contact
414-302-2304
ncorp@aurora.org
Marshfield Clinic Stevens Point Center
Stevens Point, Wisconsin 54482
United States
Recruiting Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org
Aurora Medical Center in Summit
Summit, Wisconsin 53066
United States
Recruiting Site Public Contact
414-302-2304
ncorp@aurora.org
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin 54241
United States
Recruiting Site Public Contact
414-302-2304
ncorp@aurora.org
Marshfield Clinic-Wausau Center
Wausau, Wisconsin 54401
United States
Recruiting Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin 53226
United States
Recruiting Site Public Contact
414-302-2304
ncorp@aurora.org
Aurora West Allis Medical Center
West Allis, Wisconsin 53227
United States
Recruiting Site Public Contact
414-302-2304
ncorp@aurora.org
Marshfield Clinic - Weston Center
Weston, Wisconsin 54476
United States
Recruiting Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin 54494
United States
Recruiting Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
Canada
Suspended
The Research Institute of the McGill University Health Centre (MUHC)
Montreal, Quebec H3H 2R9
Canada
Recruiting Site Public Contact
514-934-1934
evelyn.ortega@muhc.mcgill.ca
Allan Blair Cancer Centre
Regina, Saskatchewan S4T 7T1
Canada
Recruiting Site Public Contact
306-766-2213