ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. Chemotherapy drugs, such as gemcitabine, work in different ways to stop 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.

Official Title

Phase II Trial of Intravesical Gemcitabine and MK-3475 (Pembrolizumab) in the Treatment of Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

Quick Facts

Study Start:2020-03-18
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04164082

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Persistent disease (defined as not achieving disease free status) after completing therapy with at least induction BCG (\>= 5 doses) and the first round of maintenance or second induction course (\>= 2 doses). The subsequent round of BCG, either maintenance or repeat induction, must be given within 6 months of initial induction BCG
  3. * 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.
  4. * Registration must be within 12 months of last BCG instillation
  5. * 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). The subsequent round of BCG, either maintenance or repeat induction, must be given within 6 months of initial induction BCG
  6. * Disease recurrence (T1) must be within 9 months of the last BCG instillation despite having received adequate BCG as defined above
  7. * Registration must be within 12 months of last BCG instillation
  8. * Mixed variant histology (adenocarcinoma, squamous cell carcinoma) is eligible, but pure variant histology is ineligible
  9. * 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
  10. * The recurrence must be within 6 months of the last BCG dose.
  11. * Registration must be within 12 months of last maintenance BCG instillation
  12. * Patients must be deemed unfit for radical cystectomy by the treating physician or refuse radical cystectomy
  13. * All patients must have histologically confirmed urothelial cancer of the bladder within 60 days prior to registration
  14. * All visible tumor must be completely resected 60 days prior to registration (residual pure CIS is permitted)
  15. * All patients must have had a cystoscopy (or TURBT with complete resection) without papillary tumor and negative urinary cytology within 28 days of registration (positive cytology is allowed in patients with CIS)
  16. * All patients with T1 tumors must undergo a re-staging transurethral resection of bladder tumor (TURBT) within 60 days of registration
  17. * 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
  18. * Patients must have had imaging with CT or MRI abdomen/pelvis within 90 days of registration demonstrating no evidence of metastasis
  19. * Patients cannot have had a history of urothelial carcinoma in the ureters or prostatic urethra 24 months prior to registration
  20. * Patients must not be currently participating in or have participated in a study of an investigational agent or have used an investigational device within 4 weeks prior to study registration
  21. * Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been more than 4 weeks after the last dose of the previous investigational agent at time of registration
  22. * Patients must not have prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137)
  23. * Patients must not have undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years prior to registration. (Participants who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of graft versus host disease \[GVHD\])
  24. * Patients must not have received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment
  25. * Note: Participants must have recovered from all adverse events (AEs) due to previous therapies to =\< grade 1 or baseline. Participants with =\< grade 2 neuropathy may be eligible
  26. * Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment
  27. * Patients must not have received prior radiotherapy within 2 weeks of study registration. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis
  28. * Patients must not have received radiation therapy to the lung that is \> 30 Gy within 6 months prior to trial registration
  29. * Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects
  30. * 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)
  31. * A woman of childbearing potential (WOCBP) must not have a positive urine pregnancy test within 7 days prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  32. * Patients must not be pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with registration through the last dose of treatment
  33. * Age \>= 18 years
  34. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  35. * Absolute neutrophil count (ANC) \>= 1,500/mm\^3
  36. * Platelet count \>= 100,000/mm\^3
  37. * Hemoglobin \>= 9.0 g/dL
  38. * Creatinine =\< 1.5 x upper limit of normal (ULN)
  39. * In patients with creatinine \> 1.5 x ULN, if measured or calculated creatinine clearance \> 30 mL/min, then patient is eligible
  40. * Total bilirubin =\< 1.5 x ULN
  41. * In patients with a total bilirubin \> 1.5 x ULN, if direct bilirubin \< 1.0 X ULN, then patient is eligible
  42. * Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) =\< 2.5 x ULN
  43. * 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
  44. * Patients must not have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to registration
  45. * Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
  46. * Patients must not have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
  47. * Patients must not have active tuberculosis
  48. * Patients must not have been treated with antibiotics for an active infection within 14 days prior to registration. Prophylactic antibiotics are permitted. Treatment for a urinary tract infection (UTI) is allowed but must be deemed adequately treated by the treating physician prior the start of cycle 1 (C1) day 1 (D1)
  49. * Patients must not have a history of idiopathic pulmonary fibrosis or organizing pneumonia
  50. * Patients must not have a history of (non-infectious) pneumonitis that required steroids or have current pneumonitis
  51. * Patients with human immunodeficiency virus (HIV) are eligible with the following:
  52. * On effective anti-retroviral therapy with undetectable viral load within 6 months of registration
  53. * HIV-infected participants must not have a history of Kaposi sarcoma and/or multicentric Castleman disease
  54. * Patients must not have a 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
  55. * Patients must not have known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment
  56. * Patients must not have severe hypersensitivity (\>= grade 3) to pembrolizumab and/or any of its excipients
  57. * Patients must not have an active infection requiring systemic therapy
  58. * Patients must not have a known history of hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known active hepatitis C virus (defined as hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] \[qualitative\] is detected) infection
  59. * Note: No testing for hepatitis B and hepatitis C is required unless mandated by a local health authority
  60. * Patients must not have received live vaccines within 30 days of study drug administration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. COVID-19 vaccinations are permitted
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Michael E Woods
PRINCIPAL_INVESTIGATOR
Alliance for Clinical Trials in Oncology

Study Locations (Sites)

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
United States
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
United States
Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504
United States
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
United States
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
United States
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
United States
Anchorage Oncology Centre
Anchorage, Alaska, 99508
United States
Katmai Oncology Group
Anchorage, Alaska, 99508
United States
Providence Alaska Medical Center
Anchorage, Alaska, 99508
United States
Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701
United States
Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004
United States
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054
United States
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012
United States
The Medical Center of Aurora
Aurora, Colorado, 80012
United States
Boulder Community Hospital
Boulder, Colorado, 80301
United States
Boulder Community Foothills Hospital
Boulder, Colorado, 80303
United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304
United States
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, 80112
United States
Cancer Center of Colorado at Sloan's Lake
Denver, Colorado, 80204
United States
National Jewish Health-Main Campus
Denver, Colorado, 80206
United States
The Women's Imaging Center
Denver, Colorado, 80209
United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218
United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218
United States
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218
United States
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, 80218
United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220
United States
Rose Medical Center
Denver, Colorado, 80220
United States
Western Surgical Care
Denver, Colorado, 80220
United States
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, 80113
United States
Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado, 80113
United States
Swedish Medical Center
Englewood, Colorado, 80113
United States
The Melanoma and Skin Cancer Institute
Englewood, Colorado, 80113
United States
National Jewish Health-Western Hematology Oncology
Golden, Colorado, 80401
United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81501
United States
Banner North Colorado Medical Center
Greeley, Colorado, 80631
United States
Good Samaritan Hospital - Cancer Centers of Colorado
Lafayette, Colorado, 80026
United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, 80228
United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, 80120
United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, 80124
United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124
United States
Banner McKee Medical Center
Loveland, Colorado, 80539
United States
National Jewish Health-Northern Hematology Oncology
Thornton, Colorado, 80260
United States
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado, 80260
United States
Intermountain Health Lutheran Hospital
Wheat Ridge, Colorado, 80401
United States
MedStar Georgetown University Hospital
Washington, District of Columbia, 20007
United States
MedStar Washington Hospital Center
Washington, District of Columbia, 20010
United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
United States
University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610
United States
Hawaii Cancer Care - Westridge
'Aiea, Hawaii, 96701
United States
Pali Momi Medical Center
'Aiea, Hawaii, 96701
United States
Queen's Cancer Center - Pearlridge
'Aiea, Hawaii, 96701
United States
The Cancer Center of Hawaii-Pali Momi
'Aiea, Hawaii, 96701
United States
The Queen's Medical Center - West Oahu
'Ewa Beach, Hawaii, 96706
United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813
United States
Island Urology
Honolulu, Hawaii, 96813
United States
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, 96813
United States
Queen's Medical Center
Honolulu, Hawaii, 96813
United States
Straub Clinic and Hospital
Honolulu, Hawaii, 96813
United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
United States
Hawaii Cancer Care Inc-Liliha
Honolulu, Hawaii, 96817
United States
Hawaii Diagnostic Radiology Services LLC
Honolulu, Hawaii, 96817
United States
Kuakini Medical Center
Honolulu, Hawaii, 96817
United States
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, 96817
United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, 96817
United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
United States
Straub Medical Center - Kahului Clinic
Kahului, Hawaii, 96732
United States
Castle Medical Center
Kailua, Hawaii, 96734
United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, 96766
United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
United States
Walter Knox Memorial Hospital
Emmett, Idaho, 83617
United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
United States
Idaho Urologic Institute-Meridian
Meridian, Idaho, 83642
United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642
United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687
United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83687
United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864
United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, 83301
United States
OSF Saint Anthony's Health Center
Alton, Illinois, 62002
United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
United States
Illinois CancerCare-Canton
Canton, Illinois, 61520
United States
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902
United States
SIH Cancer Institute
Carterville, Illinois, 62918
United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
United States
Centralia Oncology Clinic
Centralia, Illinois, 62801
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
United States
Decatur Memorial Hospital
Decatur, Illinois, 62526
United States
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
United States
Crossroads Cancer Center
Effingham, Illinois, 62401
United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401
United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Melrose Park, Illinois, 60160
United States
SSM Health Good Samaritan
Mount Vernon, Illinois, 62864
United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
United States
Illinois CancerCare-Peru
Peru, Illinois, 61354
United States
Valley Radiation Oncology
Peru, Illinois, 61354
United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
United States
Springfield Clinic
Springfield, Illinois, 62702
United States
Springfield Memorial Hospital
Springfield, Illinois, 62781
United States
Southwest Illinois Health Services LLP
Swansea, Illinois, 62226
United States
Illinois CancerCare - Washington
Washington, Illinois, 61571
United States
Reid Health
Richmond, Indiana, 47374
United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601
United States
Central Care Cancer Center - Garden City
Garden City, Kansas, 67846
United States
Central Care Cancer Center - Great Bend
Great Bend, Kansas, 67530
United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160
United States
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, 66211
United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205
United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
United States
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, 70809
United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
United States
Mary Bird Perkins Cancer Center - Metairie
Metairie, Louisiana, 70002
United States
East Jefferson General Hospital
Metairie, Louisiana, 70006
United States
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana, 70006
United States
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112
United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112
United States
Touro Infirmary
New Orleans, Louisiana, 70115
United States
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, 21061
United States
Lowell General Hospital
Lowell, Massachusetts, 01854
United States
Mercy Medical Center
Springfield, Massachusetts, 01104
United States
Hickman Cancer Center
Adrian, Michigan, 49221
United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
United States
Bronson Battle Creek
Battle Creek, Michigan, 49017
United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
United States
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114
United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
United States
Trinity Health Medical Center - Canton
Canton, Michigan, 48188
United States
Caro Cancer Center
Caro, Michigan, 48723
United States
Chelsea Hospital
Chelsea, Michigan, 48118
United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
United States
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, 48346
United States
Newland Medical Associates-Clarkston
Clarkston, Michigan, 48346
United States
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236
United States
Henry Ford River District Hospital
East China Township, Michigan, 48054
United States
Cancer Hematology Centers - Flint
Flint, Michigan, 48503
United States
Genesee Hematology Oncology PC
Flint, Michigan, 48503
United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
United States
Hurley Medical Center
Flint, Michigan, 48503
United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
United States
Henry Ford Saint John Hospital - Academic
Grosse Pointe Woods, Michigan, 48236
United States
Henry Ford Saint John Hospital - Breast
Grosse Pointe Woods, Michigan, 48236
United States
Henry Ford Saint John Hospital - Van Elslander
Grosse Pointe Woods, Michigan, 48236
United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
United States
Ascension Borgess Cancer Center
Kalamazoo, Michigan, 49009
United States
Ascension Borgess Hospital
Kalamazoo, Michigan, 49048
United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912
United States
Hope Cancer Clinic
Livonia, Michigan, 48154
United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
United States
Henry Ford Saint John Hospital - Macomb Medical
Macomb, Michigan, 48044
United States
Henry Ford Warren Hospital - Breast Macomb
Macomb, Michigan, 48044
United States
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan, 48453
United States
Toledo Clinic Cancer Centers-Monroe
Monroe, Michigan, 48162
United States
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444
United States
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120
United States
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444
United States
Hope Cancer Center
Pontiac, Michigan, 48341
United States
Michigan Healthcare Professionals Pontiac
Pontiac, Michigan, 48341
United States
Newland Medical Associates-Pontiac
Pontiac, Michigan, 48341
United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
United States
Corewell Health Reed City Hospital
Reed City, Michigan, 49677
United States
Henry Ford Rochester Hospital
Rochester Hills, Michigan, 48309
United States
MyMichigan Medical Center Saginaw
Saginaw, Michigan, 48601
United States
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, 48604
United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085
United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085
United States
Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights, Michigan, 48312
United States
MyMichigan Medical Center Tawas
Tawas City, Michigan, 48764
United States
Munson Medical Center
Traverse City, Michigan, 49684
United States
Advanced Breast Care Center PLLC
Warren, Michigan, 48088
United States
Henry Ford Health Warren Hospital
Warren, Michigan, 48093
United States
Henry Ford Madison Heights Hospital - Breast
Warren, Michigan, 48093
United States
Henry Ford Warren Hospital - GLCMS
Warren, Michigan, 48093
United States
Macomb Hematology Oncology PC
Warren, Michigan, 48093
United States
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan, 48661
United States
University of Michigan Health - West
Wyoming, Michigan, 49519
United States
Huron Gastroenterology PC
Ypsilanti, Michigan, 48106
United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197
United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337
United States
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
United States
Cambridge Medical Center
Cambridge, Minnesota, 55008
United States
Mercy Hospital
Coon Rapids, Minnesota, 55433
United States
Fairview Southdale Hospital
Edina, Minnesota, 55435
United States
Unity Hospital
Fridley, Minnesota, 55432
United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369
United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
United States
Health Partners Inc
Minneapolis, Minnesota, 55454
United States
Monticello Cancer Center
Monticello, Minnesota, 55362
United States
New Ulm Medical Center
New Ulm, Minnesota, 56073
United States
Fairview Northland Medical Center
Princeton, Minnesota, 55371
United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422
United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
United States
Regions Hospital
Saint Paul, Minnesota, 55101
United States
United Hospital
Saint Paul, Minnesota, 55102
United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379
United States
Lakeview Hospital
Stillwater, Minnesota, 55082
United States
Ridgeview Medical Center
Waconia, Minnesota, 55387
United States
Rice Memorial Hospital
Willmar, Minnesota, 56201
United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125
United States
Fairview Lakes Medical Center
Wyoming, Minnesota, 55092
United States
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, 63011
United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
United States
Cox Cancer Center Branson
Branson, Missouri, 65616
United States
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, 63703
United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
United States
Saint Luke's Hospital
Chesterfield, Missouri, 63017
United States
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri, 65212
United States
Parkland Health Center - Farmington
Farmington, Missouri, 63640
United States
MU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri, 65109
United States
Freeman Health System
Joplin, Missouri, 64804
United States
Mercy Hospital Joplin
Joplin, Missouri, 64804
United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401
United States
Phelps Health Delbert Day Cancer Institute
Rolla, Missouri, 65401
United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506
United States
Saint Louis Cancer and Breast Institute-South City
Saint Louis, Missouri, 63109
United States
Mercy Hospital South
Saint Louis, Missouri, 63128
United States
Missouri Baptist Medical Center
Saint Louis, Missouri, 63131
United States
Mercy Hospital Saint Louis
Saint Louis, Missouri, 63141
United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670
United States
Mercy Hospital Springfield
Springfield, Missouri, 65804
United States
CoxHealth South Hospital
Springfield, Missouri, 65807
United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080
United States
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127
United States
Mercy Hospital Washington
Washington, Missouri, 63090
United States
Community Hospital of Anaconda
Anaconda, Montana, 59711
United States
Billings Clinic Cancer Center
Billings, Montana, 59101
United States
Saint Vincent Healthcare
Billings, Montana, 59101
United States
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102
United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701
United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
United States
Great Falls Clinic
Great Falls, Montana, 59405
United States
Logan Health Medical Center
Kalispell, Montana, 59901
United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802
United States
Community Medical Center
Missoula, Montana, 59804
United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
United States
The Valley Hospital - Luckow Pavilion
Paramus, New Jersey, 07652
United States
Neurosurgeons of New Jersey-Ridgewood
Ridgewood, New Jersey, 07450
United States
Valley Health System Ridgewood Campus
Ridgewood, New Jersey, 07450
United States
Valley Health System-Hematology/Oncology
Westwood, New Jersey, 07675
United States
Memorial Sloan Kettering Commack
Commack, New York, 11725
United States
Arnot Ogden Medical Center/Falck Cancer Center
Elmira, New York, 14905
United States
The New York Hospital Medical Center of Queens
Flushing, New York, 11355
United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
NYP/Weill Cornell Medical Center
New York, New York, 10065
United States
Stony Brook University Medical Center
Stony Brook, New York, 11794
United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
United States
University of North Carolina-Hillsborough Campus
Hillsborough, North Carolina, 27278
United States
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431
United States
Saint Elizabeth Boardman Hospital
Boardman, Ohio, 44512
United States
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459
United States
Miami Valley Hospital South
Centerville, Ohio, 45459
United States
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236
United States
Miami Valley Hospital
Dayton, Ohio, 45409
United States
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415
United States
Miami Valley Hospital North
Dayton, Ohio, 45415
United States
Armes Family Cancer Center
Findlay, Ohio, 45840
United States
Blanchard Valley Hospital
Findlay, Ohio, 45840
United States
Orion Cancer Care
Findlay, Ohio, 45840
United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
United States
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005
United States
Dayton Physicians LLC-Wayne
Greenville, Ohio, 45331
United States
Wayne Hospital
Greenville, Ohio, 45331
United States
Greater Dayton Cancer Center
Kettering, Ohio, 45409
United States
First Dayton Cancer Care
Kettering, Ohio, 45420
United States
Kettering Medical Center
Kettering, Ohio, 45429
United States
Mercy Health - Perrysburg Hospital
Perrysburg, Ohio, 43551
United States
Springfield Regional Cancer Center
Springfield, Ohio, 45504
United States
Springfield Regional Medical Center
Springfield, Ohio, 45504
United States
Mercy Health - Saint Anne Hospital
Toledo, Ohio, 43623
United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, 43623
United States
Dayton Physicians LLC - Troy
Troy, Ohio, 45373
United States
Upper Valley Medical Center
Troy, Ohio, 45373
United States
Saint Joseph Warren Hospital
Warren, Ohio, 44484
United States
Saint Elizabeth Youngstown Hospital
Youngstown, Ohio, 44501
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120
United States
Saint Alphonsus Cancer Care Center-Baker City
Baker City, Oregon, 97814
United States
Saint Charles Health System
Bend, Oregon, 97701
United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
United States
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015
United States
Bay Area Hospital
Coos Bay, Oregon, 97420
United States
Providence Newberg Medical Center
Newberg, Oregon, 97132
United States
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, 97914
United States
Providence Portland Medical Center
Portland, Oregon, 97213
United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
United States
Saint Charles Health System-Redmond
Redmond, Oregon, 97756
United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
United States
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301
United States
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania, 18201
United States
Ralph H Johnson VA Medical Center
Charleston, South Carolina, 29401
United States
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341
United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
United States
North Grove Medical Park
Spartanburg, South Carolina, 29303
United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
United States
Spartanburg Medical Center - Mary Black Campus
Spartanburg, South Carolina, 29307
United States
SMC Center for Hematology Oncology Union
Union, South Carolina, 29379
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565
United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
United States
UTMB Cancer Center at Victory Lakes
League City, Texas, 77573
United States
Audie L Murphy VA Hospital
San Antonio, Texas, 78229
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
United States
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah, 84003
United States
Sandra L Maxwell Cancer Center
Cedar City, Utah, 84720
United States
Logan Regional Hospital
Logan, Utah, 84321
United States
Intermountain Medical Center
Murray, Utah, 84107
United States
McKay-Dee Hospital Center
Ogden, Utah, 84403
United States
Utah Valley Regional Medical Center
Provo, Utah, 84604
United States
Riverton Hospital
Riverton, Utah, 84065
United States
Saint George Regional Medical Center
Saint George, Utah, 84770
United States
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, 84106
United States
LDS Hospital
Salt Lake City, Utah, 84143
United States
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520
United States
MultiCare Auburn Medical Center
Auburn, Washington, 98001
United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
United States
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
United States
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
United States
Providence Regional Cancer Partnership
Everett, Washington, 98201
United States
MultiCare Gig Harbor Medical Park
Gig Harbor, Washington, 98335
United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
United States
Providence Regional Cancer System-Lacey
Lacey, Washington, 98503
United States
PeaceHealth Saint John Medical Center
Longview, Washington, 98632
United States
Jefferson Healthcare
Port Townsend, Washington, 98368
United States
MultiCare Good Samaritan Hospital
Puyallup, Washington, 98372
United States
Pacific Gynecology Specialists
Seattle, Washington, 98104
United States
Swedish Medical Center-Ballard Campus
Seattle, Washington, 98107
United States
Swedish Medical Center-Cherry Hill
Seattle, Washington, 98122-5711
United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122
United States
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, 98284
United States
Providence Regional Cancer System-Shelton
Shelton, Washington, 98584
United States
MultiCare Deaconess Cancer and Blood Specialty Center - Valley
Spokane Valley, Washington, 99216
United States
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
Spokane, Washington, 99204
United States
MultiCare Deaconess Cancer and Blood Specialty Center - North
Spokane, Washington, 99218
United States
MultiCare Tacoma General Hospital
Tacoma, Washington, 98405
United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, 98664
United States
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, 99362
United States
Providence Regional Cancer System-Yelm
Yelm, Washington, 98597
United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548
United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149
United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017
United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066
United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
United States
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188
United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188
United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
United States
Cheyenne Regional Medical Center-West
Cheyenne, Wyoming, 82001
United States
Billings Clinic-Cody
Cody, Wyoming, 82414
United States
Welch Cancer Center
Sheridan, Wyoming, 82801
United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

  • Michael E Woods, PRINCIPAL_INVESTIGATOR, Alliance for Clinical Trials in Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-03-18
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2020-03-18
Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Bladder Flat Urothelial Carcinoma In Situ
  • Non-Muscle Invasive Bladder Urothelial Carcinoma
  • Stage 0a Bladder Cancer AJCC v8
  • Stage 0is Bladder Cancer AJCC v8
  • Stage I Bladder Cancer AJCC v8