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Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer

Trial Status: Active

This phase II trial studies the effect of adding pembrolizumab to gemcitabine in treating patients with non-muscle invasive bladder cancer whose cancer does not respond to Bacillus Calmette-Guerin (BCG) treatment. Drugs used in chemotherapy, such as gemcitabine, work in different ways by stopping the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the patient’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding pembrolizumab to gemcitabine may delay the return of BCG-unresponsive bladder cancer for longer period compared to gemcitabine alone.

Inclusion Criteria

  • High grade Ta, T1 or CIS urothelial carcinoma. Accrual of patients with Ta or T1 disease may be closed to ensure adequate patients enrollment to meet the primary endpoint
  • Persistent disease after completing therapy with at least induction BCG (>= 5 doses) and the first round of maintenance or second induction course (>= 2 doses) * Persistent high risk NMIBC (T1, high grade Ta and/or CIS) must be within 9 months of the last BCG instillation despite having received adequate BCG as defined above
  • High grade T1 after completing therapy with at least induction BCG (>= 5 doses) or after completing therapy with at least induction BCG (>=5 doses) and first round of maintenance or second induction course (>= 2 doses) * Persistent high risk NMIBC (T1, high grade Ta and/or CIS) must be within 9 months of the last BCG instillation despite having received adequate BCG as defined above
  • Mixed variant histology (adenocarcinoma, squamous cell carcinoma) is eligible, but pure variant histology is ineligible
  • Patients who are disease free at 6 months after starting BCG but have high grade recurrence (T1, Ta, CIS) while on maintenance therapy would be eligible * The recurrence must be within 6 months of the last BCG dose
  • Patients must be deemed unfit for radical cystectomy by the treating physician or refuse radical cystectomy
  • All visible tumor must be completely resected 60 days prior to registration (residual pure CIS is permitted) * All patients must have histologically confirmed urothelial cancer of the bladder within 60 days prior to registration. All patients must have had a cystoscopy without papillary tumor and negative urinary cytology within 21 days of registration. (positive cytology is allowed in patients with pure CIS)
  • All patients with T1 tumors must undergo a re-staging transurethral resection of bladder tumor (TURBT) within 60 days of registration. There must be uninvolved muscularis propria present in the re-staging TURBT. The initial TURBT prior to re-staging TURBT may be greater than 60 days prior to registration
  • Patients must have had imaging with computed tomography (CT) or magnetic resonance imaging (MRI) abdomen/pelvis within 90 days of registration demonstrating no evidence of metastasis.
  • Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects * Therefore, for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Hemoglobin >= 9.0 g/dL
  • Creatinine =< 1.5 x upper limit of normal (ULN) * In patients with creatinine > 1.5 x ULN, if measured or calculated creatinine clearance > 30 mL/min, then patient is eligible
  • Total Bilirubin =< 1.5 x ULN * In patients with a total bilirubin > 1.5 x ULN, if direct bilirubin < 1.0 X ULN, then patient is eligible
  • Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) =< 2.5 x ULN
  • International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN * Unless patient is receiving anticoagulant therapy, then PT or partial thromboplastin time (PTT) must be within the therapeutic range of intended use of the anticoagulant(s)
  • Activated partial thromboplastin time (aPTT) =< 1.5 x ULN * Unless patient is receiving anticoagulant therapy, then PT or PTT must be within the therapeutic range of intended use of the anticoagulant(s)
  • Patients with human immunodeficiency virus (HIV) are eligible with the following: * On stable regimen of anti-retroviral therapy (highly active anti-retroviral therapy [HAART]). * No requirement for antibiotic or antifungal for prevention of opportunistic infections. * A CD4 count about 250 cells/mcl and undetectable HIV viral load by PCR
  • Has no known additional malignancy that has had progression or has required active treatment in the last three years. Exceptions include basal or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. A history of prostate cancer that was treated with definitive intent is allowed, provided that the prostate-specific antigen (PSA) is undetectable for at least 1 year while off androgen deprivation therapy
  • No live vaccines or BCG within 30 days prior to registration
  • Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. Include as applicable: Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom).

Exclusion Criteria

  • Patients cannot have had a history of urothelial carcinoma in the ureters or prostatic urethra 24 months prior to registration
  • Patients must not have received any prior or concurrent systemic chemotherapy or immunotherapy (prior intravesical chemotherapy and interferon is permitted). Single dose chemotherapy post TURBT is permitted
  • Patients must not have received any prior bladder radiation
  • Patients must not have had an active autoimmune disease requiring systemic treatment within 24 months prior to registration. Autoimmune diseases include, but not limited to, lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, 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 organ or bone marrow transplant
  • Patients must not have active tuberculosis
  • Patients must not have been treated with antibiotics for an active infection within 14 days prior to registration. Prophylactic antibiotics are permitted
  • Patients must not have a history of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or active pneumonitis
  • Patients must not have active hepatitis B or C (resolved disease with positive anti-hepatitis B core [HBc] antibody or negative polymerase chain reaction [PCR] for hepatitis C [HCV] RNA permitted)
  • Glucocorticoids for any purpose other than to modulate symptoms from an adverse event of suspected immunologic etiology. Physiologic doses of corticosteroids are allowed
  • Physicians should consider whether any of the following may render the patient inappropriate for this protocol: * Psychiatric illness which would prevent the patient from giving informed consent. * Medical condition such as uncontrolled infection, uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.

Alaska

Anchorage
Alaska Breast Care and Surgery LLC
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Alaska Oncology and Hematology LLC
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Alaska Women's Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Anchorage Associates in Radiation Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Anchorage Oncology Centre
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Anchorage Radiation Therapy Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Katmai Oncology Group
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Providence Alaska Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Fairbanks
Fairbanks Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-458-3043

Arizona

Phoenix
Mayo Clinic Hospital in Arizona
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015
Scottsdale
Mayo Clinic in Arizona
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015

Arkansas

Ft. Smith
Mercy Hospital Fort Smith
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-378-9373

California

Burbank
Providence Saint Joseph Medical Center / Disney Family Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 818-847-4793
Sacramento
University of California Davis Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 916-734-3089

Colorado

Aurora
Rocky Mountain Cancer Centers-Aurora
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
The Medical Center of Aurora
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Boulder
Boulder Community Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 303-777-2663
Rocky Mountain Cancer Centers-Boulder
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Centennial
Rocky Mountain Cancer Centers - Centennial
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Denver
Cancer Center of Colorado at Sloan's Lake
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Colorado Blood Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
National Jewish Health-Main Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-225-5654
Presbyterian - Saint Lukes Medical Center - Health One
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Rocky Mountain Cancer Centers-Midtown
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Rocky Mountain Cancer Centers-Rose
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Rose Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 303-777-2663
SCL Health Saint Joseph Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
The Women's Imaging Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Western Surgical Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Englewood
Mountain Blue Cancer Care Center - Swedish
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Swedish Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Golden
National Jewish Health-Western Hematology Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Grand Junction
Saint Mary's Hospital and Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Greeley
North Colorado Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Lafayette
Good Samaritan Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-673-1622
Littleton
Rocky Mountain Cancer Centers-Littleton
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Lone Tree
Rocky Mountain Cancer Centers-Sky Ridge
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Sky Ridge Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Loveland
McKee Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Thornton
National Jewish Health-Northern Hematology Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Wheat Ridge
SCL Health Lutheran Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663

Florida

Fort Lauderdale
Holy Cross Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 954-267-7750

Guam

Tamuning
FHP Health Center-Guam
Status: ACTIVE
Contact: Site Public Contact
Phone: 671-646-5825

Hawaii

Aiea
Hawaii Cancer Care - Savio
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-539-2273
Pali Momi Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-486-6000
Queen's Cancer Center - Pearlridge
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-487-7447
The Cancer Center of Hawaii-Pali Momi
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-678-9000
Honolulu
Hawaii Cancer Care Inc-Liliha
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-536-4888
Hawaii Cancer Care Inc-POB II
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-524-6115
Island Urology
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-536-2306
Kapiolani Medical Center for Women and Children
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-983-6090
Kuakini Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-547-9816
Queen's Cancer Cenrer - POB I
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-532-0315
Queen's Cancer Center - Kuakini
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-531-8521
Queen's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-545-8548
Straub Clinic and Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-522-4333
The Cancer Center of Hawaii-Liliha
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-547-6881
University of Hawaii Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-586-2979
Lihue
Wilcox Memorial Hospital and Kauai Medical Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-535-7960

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Luke's Mountain States Tumor Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Coeur D'Alene
Kootenai Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Emmett
Walter Knox Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Fruitland
Saint Luke's Cancer Institute - Fruitland
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774
Meridian
Idaho Urologic Institute-Meridian
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Luke's Cancer Institute - Meridian
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774
Nampa
Saint Alphonsus Medical Center-Nampa
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Luke's Cancer Institute - Nampa
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774
Post Falls
Kootenai Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Sandpoint
Kootenai Cancer Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Twin Falls
Saint Luke's Cancer Institute - Twin Falls
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774

Illinois

Bloomington
Illinois CancerCare-Bloomington
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Canton
Illinois CancerCare-Canton
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Carbondale
Memorial Hospital of Carbondale
Status: ACTIVE
Contact: Site Public Contact
Phone: 618-457-5200
Carterville
SIH Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 618-985-3333
Carthage
Illinois CancerCare-Carthage
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Centralia
Centralia Oncology Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Chicago
Rush University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 312-942-5498
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Decatur Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Dixon
Illinois CancerCare-Dixon
Status: ACTIVE
Contact: Site Public Contact
Phone: 815-285-7800
Effingham
Crossroads Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Eureka
Illinois CancerCare-Eureka
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Galesburg
Illinois CancerCare-Galesburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Western Illinois Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-344-2831
Kewanee
Illinois CancerCare-Kewanee Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Macomb
Illinois CancerCare-Macomb
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Maywood
Loyola University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 708-226-4357
Melrose Park
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Status: ACTIVE
Contact: Site Public Contact
Phone: 708-450-4554
Mount Vernon
Good Samaritan Regional Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 618-242-4600
O'Fallon
Cancer Care Center of O'Fallon
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Pekin
Illinois CancerCare-Pekin
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Peoria
Illinois CancerCare-Peoria
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Methodist Medical Center of Illinois
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Peru
Illinois CancerCare-Peru
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Valley Radiation Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 815-664-4141
Princeton
Illinois CancerCare-Princeton
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Springfield
Memorial Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-788-3528
Southern Illinois University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-545-7929
Springfield Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-444-7541
Swansea
Southwest Illinois Health Services LLP
Status: ACTIVE
Contact: Site Public Contact
Phone: 618-236-1000

Indiana

Richmond
Reid Health
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
South Bend
Memorial Hospital of South Bend
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-284-7370

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 859-257-3379

Louisiana

Metairie
East Jefferson General Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 504-210-3539
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 504-210-3539
New Orleans
Louisiana State University Health Science Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 504-210-3539

Maryland

Glen Burnie
UM Baltimore Washington Medical Center / Tate Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 410-553-8100

Massachusetts

Springfield
Mercy Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 413-748-9234

Michigan

Adrian
Hickman Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 517-265-0116
Ann Arbor
Saint Joseph Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Battle Creek
Bronson Battle Creek
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Brighton
IHA Hematology Oncology Consultants-Brighton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Joseph Mercy Brighton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Canton
IHA Hematology Oncology Consultants-Canton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Joseph Mercy Canton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Caro
Caro Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Chelsea
IHA Hematology Oncology Consultants-Chelsea
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Joseph Mercy Chelsea
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Clarkston
Hematology Oncology Consultants-Clarkston
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Newland Medical Associates-Clarkston
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Detroit
Ascension Saint John Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
East China
Great Lakes Cancer Management Specialists-Doctors Park
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Flint
Genesee Cancer and Blood Disease Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Genesee Hematology Oncology PC
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Genesys Hurley Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Hurley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Mercy Health Saint Mary's
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Spectrum Health at Butterworth Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Grosse Pointe Woods
Academic Hematology Oncology Specialists
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Michigan Breast Specialists-Grosse Pointe Woods
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Kalamazoo
Borgess Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Bronson Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
West Michigan Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Lansing
Sparrow Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Livonia
Hope Cancer Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Mary Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Macomb Township
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Michigan Breast Specialists-Macomb Township
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Marlette
Saint Mary's Oncology / Hematology Associates of Marlette
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Monroe
Toledo Clinic Cancer Centers-Monroe
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-444-3561
Muskegon
Mercy Health Mercy Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Niles
Lakeland Hospital Niles
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Norton Shores
Cancer and Hematology Centers of Western Michigan - Norton Shores
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Pontiac
21st Century Oncology-Pontiac
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Hope Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Newland Medical Associates-Pontiac
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Joseph Mercy Oakland
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Reed City
Spectrum Health Reed City Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Rochester Hills
Great Lakes Cancer Management Specialists-Rochester Hills
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saginaw
Ascension Saint Mary's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Oncology Hematology Associates of Saginaw Valley PC
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Joseph
Lakeland Medical Center Saint Joseph
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Marie Yeager Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Sterling Heights
Bhadresh Nayak MD PC-Sterling Heights
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Tawas City
Ascension Saint Joseph Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Traverse City
Munson Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Warren
Advanced Breast Care Center PLLC
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Great Lakes Cancer Management Specialists-Macomb Professional Building
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Macomb Hematology Oncology PC
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Michigan Breast Specialists-Warren
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint John Macomb-Oakland Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
West Branch
Saint Mary's Oncology / Hematology Associates of West Branch
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Wyoming
Metro Health Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Ypsilanti
Huron Gastroenterology PC
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
IHA Hematology Oncology Consultants-Ann Arbor
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671

Minnesota

Burnsville
Fairview Ridges Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Minnesota Oncology - Burnsville
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Cambridge
Cambridge Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Coon Rapids
Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Edina
Fairview Southdale Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Fridley
Unity Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Maple Grove
Fairview Clinics and Surgery Center Maple Grove
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Saint John's Hospital - Healtheast
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Minneapolis
Abbott-Northwestern Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Health Partners Inc
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Hennepin County Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Monticello
Monticello Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
New Ulm
New Ulm Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Princeton
Fairview Northland Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Robbinsdale
North Memorial Medical Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Saint Paul
Regions Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
United Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Shakopee
Saint Francis Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Stillwater
Lakeview Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Waconia
Ridgeview Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Willmar
Rice Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Woodbury
Minnesota Oncology Hematology PA-Woodbury
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Wyoming
Fairview Lakes Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517

Missouri

Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-251-7058
Branson
Cox Cancer Center Branson
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 417-269-4520
Cape Girardeau
Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Southeast Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-651-5550
Columbia
University of Missouri - Ellis Fischel
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-882-7440
Farmington
Parkland Health Center - Farmington
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Jefferson City
Capital Region Southwest Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-632-4814
Joplin
Freeman Health System
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-347-4030
Mercy Hospital Joplin
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-556-3074
Rolla
Delbert Day Cancer Institute at PCRMC
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-458-8776
Mercy Clinic-Rolla-Cancer and Hematology
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-458-6379
Saint Joseph
Heartland Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 816-271-7937
Saint Louis
Mercy Hospital Saint Louis
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-251-7066
Mercy Hospital South
Status: ACTIVE
Contact: Site Public Contact
Missouri Baptist Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Saint Louis Cancer and Breast Institute-South City
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-353-1870
Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Springfield
CoxHealth South Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520
Mercy Hospital Springfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520
Sullivan
Missouri Baptist Sullivan Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Washington
Mercy Hospital Washington
Status: ACTIVE
Contact: Site Public Contact
Phone: 636-390-1600

Montana

Anaconda
Community Hospital of Anaconda
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Billings
Billings Clinic Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-996-2663
Saint Vincent Frontier Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-648-6274
Saint Vincent Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Bozeman
Bozeman Deaconess Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Butte
Saint James Community Hospital and Cancer Treatment Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-723-2621
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Great Falls Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Kalispell
Kalispell Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Missoula
Community Medical Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Saint Patrick Hospital - Community Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-327-3118

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-639-6918

New Jersey

Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
Middletown
Memorial Sloan Kettering Monmouth
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
Montvale
Memorial Sloan Kettering Bergen
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
Paramus
The Valley Hospital-Luckow Pavilion
Status: ACTIVE
Contact: Site Public Contact
Phone: 201-634-5792
Ridgewood
Neurosurgeons of New Jersey-Ridgewood
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-9171
Valley Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 201-634-5792
Westwood
Valley Health System-Hematology / Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-9171

New York

Commack
Memorial Sloan Kettering Commack
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
Flushing
The New York Hospital Medical Center of Queens
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-823-5923
New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
NYP / Weill Cornell Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-746-1848
Uniondale
Memorial Sloan Kettering Nassau
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
West Harrison
Memorial Sloan Kettering Westchester
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-668-0683
Hillsborough
University of North Carolina-Hillsborough Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-668-0683

Ohio

Beavercreek
Indu and Raj Soin Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Boardman
Saint Elizabeth Boardman Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Centerville
Dayton Physicians LLC-Miami Valley South
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Miami Valley Hospital South
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Cincinnati
Oncology Hematology Care Inc-Kenwood
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Dayton
Dayton Physician LLC-Miami Valley Hospital North
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Miami Valley Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Findlay
Armes Family Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Blanchard Valley Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Orion Cancer Care
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 937-528-2900
Franklin
Atrium Medical Center-Middletown Regional Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Dayton Physicians LLC-Atrium
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Greenville
Dayton Physicians LLC-Wayne
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Wayne Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Kettering
First Dayton Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-416-9270
Greater Dayton Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Kettering Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Perrysburg
Mercy Health Perrysburg Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 419-479-5605
Springfield
Springfield Regional Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 937-528-2900
Springfield Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 937-528-2900
Toledo
Mercy Saint Anne Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 419-407-1160
Toledo Clinic Cancer Centers-Toledo
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-444-3561
Troy
Dayton Physicians LLC-Upper Valley
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Upper Valley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Warren
Saint Joseph Warren Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Youngstown
Saint Elizabeth Youngstown Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900

Oklahoma

Oklahoma City
Mercy Hospital Oklahoma City
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-752-3402
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-271-8777

Oregon

Baker City
Saint Alphonsus Medical Center-Baker City
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Bend
Saint Charles Health System
Status: ACTIVE
Contact: Site Public Contact
Phone: 541-706-2909
Clackamas
Clackamas Radiation Oncology Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Providence Cancer Institute Clackamas Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Coos Bay
Bay Area Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 541-269-8392
Newberg
Providence Newberg Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Ontario
Saint Alphonsus Medical Center-Ontario
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Portland
Providence Portland Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Providence Saint Vincent Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Redmond
Saint Charles Health System-Redmond
Status: ACTIVE
Contact: Site Public Contact
Phone: 541-706-2909

Pennsylvania

Allentown
Lehigh Valley Hospital-Cedar Crest
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Bethlehem
Lehigh Valley Hospital - Muhlenberg
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
East Stroudsburg
Pocono Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-422-1700
Hazleton
Lehigh Valley Hospital-Hazleton
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-501-1242

Puerto Rico

Bayamon
Cancer Center-Metro Medical Center Bayamon
Status: ACTIVE
Contact: Site Public Contact
Phone: 787-395-7085
Caguas
HIMA San Pablo Oncologic Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 787-653-3434
Manati
Doctors Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 787-621-4397
Ponce
Instituto Oncologia Moderna Ponce
Status: ACTIVE
Contact: Site Public Contact
Phone: 787-848-0606
San Juan
Centro Comprensivo de Cancer de UPR
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-823-5923
San Juan City Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 787-763-1296
San Juan Community Oncology Group
Status: ACTIVE
Contact: Site Public Contact
Phone: 787-274-3387

South Carolina

Charleston
Ralph H Johnson VA Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 843-789-7020

Texas

Galveston
University of Texas Medical Branch
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 409-772-1950
League City
UTMB Cancer Center at Victory Lakes
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-917-8906
San Antonio
Audie L Murphy VA Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-469-5300
University of Texas Health Science Center at San Antonio
Status: ACTIVE
Contact: Site Public Contact
Phone: 210-450-3800

Utah

American Fork
American Fork Hospital / Huntsman Intermountain Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 801-855-4100
Cedar City
Sandra L Maxwell Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 435-868-5680
Logan
Logan Regional Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 435-716-6400
Murray
Intermountain Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 801-507-3950
Ogden
McKay-Dee Hospital Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 801-387-7426
Provo
Utah Valley Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 801-357-7965
Riverton
Riverton Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 801-507-3950
Saint George
Dixie Medical Center Regional Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 435-688-4167
Salt Lake City
LDS Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 801-408-1347
Utah Cancer Specialists-Salt Lake City
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 801-933-6070

Washington

Aberdeen
Providence Regional Cancer System-Aberdeen
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958
Auburn
MultiCare Auburn Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-887-9333
Bellingham
PeaceHealth Saint Joseph Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-788-8238
Centralia
Providence Regional Cancer System-Centralia
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958
Edmonds
Swedish Cancer Institute-Edmonds
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Everett
Providence Regional Cancer Partnership
Status: ACTIVE
Contact: Site Public Contact
Phone: 425-261-3529
Gig Harbor
MultiCare Gig Harbor Medical Park
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-403-2394
Issaquah
Swedish Cancer Institute-Issaquah
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Kennewick
Kadlec Clinic Hematology and Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 509-783-4637
Lacey
Providence Regional Cancer System-Lacey
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958
Longview
PeaceHealth Saint John Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-514-2016
Port Townsend
Jefferson Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-344-3091
Puyallup
MultiCare Good Samaritan Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-351-7955
Seattle
Pacific Gynecology Specialists
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Swedish Medical Center-Ballard Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Swedish Medical Center-Cherry Hill
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Swedish Medical Center-First Hill
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Sedro-Woolley
PeaceHealth United General Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-788-8238
Shelton
Providence Regional Cancer System-Shelton
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958
Spokane
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-403-7249
MultiCare Deaconess Cancer and Blood Specialty Center - North
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-402-7249
Spokane Valley
MultiCare Deaconess Cancer and Blood Specialty Center - Valley
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-403-7249
Tacoma
MultiCare Tacoma General Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-403-3229
Vancouver
PeaceHealth Southwest Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-514-3940
Walla Walla
Providence Saint Mary Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 509-897-5993
Yelm
Providence Regional Cancer System-Yelm
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958

Wisconsin

Eau Claire
Marshfield Medical Center-EC Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Marshfield
Marshfield Medical Center-Marshfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Milwaukee
Medical College of Wisconsin
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-805-3666
Minocqua
Marshfield Clinic-Minocqua Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Mukwonago
ProHealth D N Greenwald Center
Status: ACTIVE
Contact: Site Public Contact
New Richmond
Cancer Center of Western Wisconsin
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Oconomowoc
ProHealth Oconomowoc Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 262-928-7878
Rice Lake
Marshfield Medical Center-Rice Lake
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Stevens Point
Marshfield Clinic Stevens Point Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Waukesha
ProHealth Waukesha Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 262-928-7632
UW Cancer Center at ProHealth Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 262-928-5539
Weston
Marshfield Clinic - Weston Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581

Wyoming

Cheyenne
Cheyenne Regional Medical Center-West
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Cody
Billings Clinic-Cody
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-996-2663
Sheridan
Welch Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060

PRIMARY OBJECTIVES:

I. Estimate the 6-month complete response rate of treatment with intravesical gemcitabine hydrochloride (gemcitabine) in combination with MK-3475 (pembrolizumab) in patients with Bacillus Calmette-Guerin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) that have a carcinoma in situ (CIS) component.

II. Estimate the 18 month event-free survival (EFS) rate for all patients with BCG-unresponsive NMIBC receiving intravesical gemcitabine in combination with pembrolizumab.

SECONDARY OBJECTIVES:

I. To characterize the safety profile of the combination of intravesical gemcitabine with pembrolizumab with BCG-unresponsive NMIBC (CIS or high grade Ta and T1 with or without a CIS component).

II. To estimate progression-free survival (PFS) of patients with BCG-unresponsive NMIBC treated with intravesical gemcitabine in combination with pembrolizumab.

III. To estimate overall survival (OS) of patients with BCG-unresponsive NMIBC treated with intravesical gemcitabine in combination with pembrolizumab.

IV. To estimate cystectomy-free survival of patients with BCG-unresponsive NMIBC treated with intravesical gemcitabine in combination with pembrolizumab.

V. To estimate recurrence-free survival (RFS) for patients with a CIS component only and those without a CIS component.

EXPLORATORY OBJECTIVES:

I. To assess correlation between tumor mutation burden (TMB) and EFS and 6-month complete response (CR) rate.

II. To assess correlation between specific genomic alterations (single nucleotide variant [SNV] and copy number gains/loss) and EFS and 6-month complete response rate.

III. To assess correlation between APOBEC mutational signature and EFS and 6-month complete response rate.

IV. To assess correlation between immune gene signatures (IGS) and EFS and 6-month complete response rate.

V. To assess correlation between PD-L1 ribonucleic acid (RNA) levels and EFS and 6-month complete response rate.

VI. To assess correlation between RNA molecular subtype and EFS and 6-month complete response rate.

VII. To assess correlation between intratumoral T-cell receptor (TCR) clonality and EFS and 6-month complete response rate.

VIII. To assess correlation between changes in peripheral blood TCR clonality and EFS and 6-month complete response rate.

IX. To assess EFS in patients with urine cell free deoxyribonucleic acid (DNA) (cfDNA) + versus (vs.) patients with cfDNA.

OUTLINE:

INDUCTION: Patients receive pembrolizumab intravenously (IV) over 25-40 minutes on day 1 of cycles 1-4. Patients also receive gemcitabine hydrochloride intravesically on days 1, 8 and 15 of cycles 1 and 2. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Beginning cycle 5, patients with no evidence of disease after induction receive pembrolizumab IV over 25-40 minutes and gemcitabine intravesically on day 1. Treatment repeats every 3 weeks for 12 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment or stop in study treatment for reasons other than progression/recurrence or subsequent treatment, patients are followed every 3 months for 2 years and then every 6 months for up to 5 years from study registration or until disease progression or recurrence. After documentation of disease progression or recurrence or receiving non-protocol therapy, patients are followed every 6 months for up to 5 years total from study registration. Patients who discontinue prior to starting any protocol treatment (with or without progression) will go to survival follow-up, followed every 6 months for up to 5 years from registration or until death, whichever comes first.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Alliance for Clinical Trials in Oncology

Principal Investigator
Michael Edward Woods

  • Primary ID A031803
  • Secondary IDs NCI-2019-07573
  • Clinicaltrials.gov ID NCT04164082