Bladder Cancer Clinical Trial

A Study of Chemotherapy and Radiation Therapy Compared to Chemotherapy and Radiation Therapy Plus MEDI4736 (Durvalumab) Immunotherapy for Bladder Cancer Which Has Spread to the Lymph Nodes (The INSPIRE Study)

Summary

This phase II trial studies the benefit of adding an immunotherapy drug called MEDI4736 (durvalumab) to standard chemotherapy and radiation therapy in treating bladder cancer which has spread to the lymph nodes. Drugs used in standard chemotherapy 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. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with durvalumab may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving chemotherapy and radiation therapy with the addition of durvalumab may work better in helping tumors respond to treatment compared to chemotherapy and radiation therapy alone. Patients with limited regional lymph node involvement may benefit from attempt at bladder preservation, and use of immunotherapy and systemic chemotherapy.

View Full Description

Full Description

PRIMARY OBJECTIVE:

I. To compare the clinical complete response rate (cCR) after chemoradiotherapy (chemoRT) with or without durvalumab in node-positive bladder cancer patients.

SECONDARY OBJECTIVES:

I. To compare the toxicity profile in both arms using the Common Terminology Criteria for Adverse Events (CTCAE).

II. To estimate the progression-free survival (PFS) in both arms. III. To estimate overall survival (OS) post randomization in both arms. IV. To estimate the bladder intact event free survival (BIEFS) in both arms. V. To estimate the metastasis free survival (MFS) in both arms. VI. To estimate bladder cancer specific survival in both arms. VII. To estimate the complete clinical response duration in both arms. VIII. To estimate salvage cystectomy rates in both arms.

EXPLORATORY OBJECTIVE:

I. Planned subgroup analyses for clinical outcome (clinical complete response [CR] rate post chemoRT +/- durvalumab, MFS, OS, PFS) based on stratification factors.

TRANSLATIONAL OBJECTIVE:

I. To collect and bank tumor tissue and blood specimens at pre-and post-treatment with chemoRT +/- durvalumab to determine predictive or prognostic markers.

OUTLINE:

STEP 1 - Randomization: Patients are randomized to 1 of 2 arms.

ARM C: Patients undergo radiation therapy for 6.5-8 weeks. Beginning 4 days before or after starting radiation therapy, patients receive durvalumab intravenously (IV) over 60 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Beginning 4 days before or after starting radiation therapy, patients also receive gemcitabine hydrochloride IV over 30-60 minutes twice a week (BIW) for 6 weeks; cisplatin IV over 30-60 minutes once a week (QW) for 6 weeks; or mitomycin IV over 30 minutes on day 1 of radiation and fluorouracil IV continuous infusion on days 1-5 and 16-20 of radiation in the absence of disease progression or unacceptable toxicity. Patients also undergo bladder biopsy, cystoscopy, and computed tomography (CT) or magnetic resonance imaging (MRI) on study. Patients may also undergo tumor tissue and blood sample collection on study.

ARM D: Patients undergo radiation therapy for 6.5-8 weeks. Beginning 4 days before or after starting radiation therapy, patients also receive gemcitabine hydrochloride IV over 30-60 minutes BIW for 6 weeks; cisplatin IV over 30-60 minutes QW for 6 weeks; or mitomycin IV over 30 minutes on day 1 of radiation and fluorouracil IV continuous infusion on days 1-5 and 16-20 of radiation in the absence of disease progression or unacceptable toxicity. Patients also undergo bladder biopsy, cystoscopy, and CT or MRI on study. Patients may also undergo tumor tissue and blood sample collection on study.

STEP 2 - Registration: Patients are assigned to 1 of 2 arms.

ARM E: Patients previously randomized to Arm C (chemoradiation and durvalumab) who achieve clinical CR or clinical benefit receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo bladder biopsy, cystoscopy, and CT or MRI on study. Patients may also undergo tumor tissue and blood sample collection on study.

ARM F: Patients previously randomized to Arm D (chemoradiation) who achieve clinical CR or clinical benefit, or patients previously randomized to Arm C with no clinical CR or clinical benefit undergo observation. Patients also undergo bladder biopsy, cystoscopy, and CT or MRI on study. Patients may also undergo tumor tissue and blood sample collection on study.

After completion of study treatment, patients are followed up every 12 weeks for 1 year, every 6 months for year 2, and then annually for years 3-4.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Step 1 (Randomization) Inclusion
Patient must be >= 18 years of age
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at the time of step 1 randomization

Patient must have histologically proven pure or mixed urothelial cancer of the bladder

NOTE: Small cell carcinoma is excluded, however other variant histologies are permitted provided a component of urothelial carcinoma is present
Patient must have documented node-positive and non-metastatic disease (any T, any N, M0). Node positivity must have been defined prior to receiving and systemic chemotherapy or induction chemotherapy.

Node positivity can fall into either of the following categories and will be defined by imaging and/or biopsy:

A lymph node >= 1.0 cm in short axis on imaging (i.e., CT or MRI or positron emission tomography [PET]/CT)

A lymph node that is < 1 cm on imaging with either a biopsy confirming involvement with cancer

For patients who have received induction chemotherapy (any type of systemic chemotherapy) for node positive bladder cancer prior to enrollment, there must be no signs of disease progression (CR/PR or stable disease [SD]) based on restaging imaging and cystoscopy, which consists of:

CT chest, abdomen, and pelvis obtained after completion of induction chemotherapy and within 8 weeks prior to step 1 randomization

NOTE: MRI can be used instead of CT per treating physician discretion
Cystoscopic evaluation and attempt to perform maximal TURBT performed by the participating urologist after completion of induction chemotherapy and within 12 weeks prior to step 1 randomization. If maximal TURBT is not possible for medical reasons, the enrollment must be discussed and approved with the study chair. Documentation of correspondences with the study chair must be kept on file

Patients who achieve CR upon cystoscopy per urologist with no visible tumor (i.e., no need for additional TURBT), are allowed to proceed in the study as adequate resection with no residual disease in bladder

For patients who did not receive induction chemotherapy (any type of systemic chemotherapy) for node positive bladder cancer prior to enrollment, the following must be obtained:

CT chest, abdomen, and pelvis completed within 8 weeks prior to step 1 randomization.

NOTE: MRI can be used instead of CT per treating physician discretion
Cystoscopic evaluation and attempt to perform maximal TURBT performed by the participating urologist within 12 weeks prior to Step 1 randomization. If maximal TURBT is not possible for medical reasons, the enrollment must be discussed and approved with the study chair. Documentation of correspondences with the study chair must be kept on file.

For patients who may need repeat TURBT if their old TURBT has fallen out of window: If urologist determine no visible tumor (i.e., no need for additional resection) upon cystoscopy, they are allowed to proceed in the study as complete resection

Patient must agree to undergo CT simulation and treatment planning. If this is the first case registered at the site, then a pre-treatment RT review will be required and will take up to 3 business days. The patient cannot start radiation treatment prior to successful completion of this pre-treatment review. Therefore, careful planning is necessary to meet the deadline of starting radiation within 20 business days of Step 1 randomization
Patients with previous exposure to immune checkpoint inhibitor for non-muscle invasive disease are eligible. If given for NMIBC, the last dose must have been completed > 12 months prior to step 1 randomization
Leukocytes >= 3,000/mcL (obtained < 14 days prior to step 1 randomization)
Absolute neutrophil count (ANC) >= 1,500/mcL (obtained < 14 days prior to step 1 randomization)
Hemoglobin >= 9 g/dL (obtained < 14 days prior to step 1 randomization)
Platelets >= 100,000/mcL (obtained < 14 days prior to step 1 randomization)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (obtained < 14 days prior to step 1 randomization)
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained < 14 days prior to step 1 randomization)
Adequate renal function as evidenced by calculated (Cockcroft's formula) creatinine clearance or 24 hours actual creatinine clearance >= 30mL/min. The creatinine used to calculate the clearance result must have been obtained within 14 days prior to step 1 randomization. Actual body weight, not ideal body weight, must be used in the calculation
Patients with human immunodeficiency virus (HIV) on effective anti-retroviral therapy with undetectable viral load within 6 months of step 1 randomization are eligible for this trial
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Site is encouraged to discuss with the study chair if needed prior to enrollment
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class IIB or better
Step 2 (Registration: Adjuvant Durvalumab vs. Observation) Inclusion
Patient must have evaluation to determine clinical outcome post step 1 treatment (chemoRT+/- durvalumab) with imaging (CT chest, abdomen, and pelvis)(preferably contrast with urogram, if not contraindicated) and cystoscopy with biopsy confirmation to ensure no progression and absence of >= T2 disease in the bladder. Patient should be registered to step 2 within 28 days from the determination of primary response to step 1 treatment. However, for patients previously on Arm C, an additional 4 week delay to step 2 registration is allowed
Patient on the chemoRT+ durvalumab (Arm C) must meet the following:
Patient must have achieved either complete clinical response OR have demonstrated clinical benefit prior to continuing onto adjuvant durvalumab
Patients who are to go on the adjuvant durvalumab (Arm E) must have recovered to at least grade 2 or less immune related AE prior to starting treatment except for immune related alopecia, clinically asymptomatic endocrinopathies. For patients who may have gotten immune related AEs during chemoRT+ durvalumab (Arm C), step 2 registration could be delayed up to additional 4 weeks to ensure recovery to at least grade 2 or lower prior to starting adjuvant therapy. However patients with durvalumab related AEs that require permanent discontinuation of durvalumab will not continue on the adjuvant treatment regardless of the response
Patient must not have experienced immune related neurological disorder described as Guillain-Barré syndrome, myasthenic syndrome or myasthenia gravis, or meningoencephalitis during chemoRT+ durvalumab treatment
Patient must not have experienced immune related myocarditis or immune related pericarditis during chemoRT+ durvalumab treatment
ANC >= 1,000 mcL (must be obtained < 28 days prior to step 2 registration)
Hemoglobin >= 8g/dL (must be obtained < 28 days prior to step 2 registration)

Platelets >= 70,000 mcL (must be obtained < 28 days prior to step 2 registration)

NOTE: If recovery is not achieved, blood counts could be repeated weekly and step 2 registration could be delayed up to additional 4 weeks

Patient on the chemoRT arm (Arm D) must have achieved either complete clinical response OR have demonstrated clinical benefit prior to be placed on the observation alone arm (Arm F)

Exclusion Criteria:

Step 1 (Randomization) Exclusion
Patient must not have received any previous radiation therapy to the pelvic area
Patient must not have presence of concomitant active upper tract tumors or urethra tumors. History of previously adequately treated non-muscle invasive bladder cancer (NMIBC) are eligible; previously treated urothelial cancer or histological variant at any site outside of the urinary bladder are allowed, provided they have been Ta/T1/carcinoma in situ (CIS) and post treatment follow up imaging and endoscopic evaluation shows no evidence of disease
Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.

All patients of childbearing potential must have a blood test or urine study within 14 days prior to step 1 randomization to rule out pregnancy.

A patient of childbearing potential is defined as any patient, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

Patients must not expect to conceive or father children by using accepted and effected method(s) of contraception or by abstaining from sexual intercourse from the time of Step 1 randomization for the duration of their participation in the study and continue for at least 3 months after the last dose of protocol treatment

For patients with autoimmune conditions, patient must not have history of prior documented autoimmune disease within 2 years prior to step 1 randomization

NOTE: Patient with vitiligo, Grave's disease, eczema or psoriasis (not requiring systemic treatment within 2 years prior to step 1 randomization) are not excluded. Patients with history of completely resolved childhood asthma or atopy are not excluded. Patients with asthma not requiring more than 10 mg/d or equivalent of prednisone are not excluded. Patients with well-controlled hypothyroidism on thyroxine replacement will be eligible as well. Patients with known history of hypoadrenalism on maintenance steroids will be eligible. Patients with type I diabetes mellitus will be eligible, provided their disease is well controlled. History of autoimmune related alopecia is also not an exclusion criteria
Patient with active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) are not eligible
Patient with a history of and/or confirmed pneumonitis are not eligible
Patient with a history of primary immunodeficiency are not eligible
Patient with history of allogeneic organ transplant are not eligible

Patient must not have an active infection, including:

Tuberculosis (based on clinical evaluation that includes clinical history, physical examination, and radiographic findings, and tuberculosis testing in line with local practice)
Hepatitis B (HBV) (known positive HBV surface antigen [HBsAg] result). Past or resolved HBV infection (defined as the presence of hepatitis b core antibody [anti-HBc] and absence of HBsAg) are eligible
Hepatitis C Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction test is negative for HCV ribonucleic acid (RNA)
Patient must not have clinically significant liver disease that precludes patient from treatment regimens prescribed on the study (including, but not limited to, active viral, alcoholic or other autoimmune hepatitis, cirrhosis or inherited liver disease)

Patient must not have received live attenuated vaccine within 30 days prior to the first dose of durvalumab

NOTE: Patient, if enrolled, must not receive live vaccine whilst receiving durvalumab and up to 30 days after the last dose of durvalumab
NOTE: Patient is permitted to receive inactivated vaccines and any non-live vaccines including those for the seasonal influenza and COVID-19 (Note: intranasal influenza vaccines, such as Flu-Mist are live attenuated vaccines and are not allowed). If possible, it is recommended to separate study drug administration from vaccine administration by about a week (primarily in order to minimize an overlap of adverse events)

Patient must not have current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:

Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection).
Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent.
Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)

Patient must not have any unresolved toxicity (National Cancer Institute [NCI] CTCAE grade >= 2) from previous anti-cancer therapy with the exception of alopecia, vitiligo, and the laboratory values

NOTE: Patients with grade >= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study chair
NOTE: Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the study chair. Documentation of correspondences with the study chair must be kept on file

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

95

Study ID:

NCT04216290

Recruitment Status:

Active, not recruiting

Sponsor:

National Cancer Institute (NCI)

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There are 182 Locations for this study

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Anchorage Associates in Radiation Medicine
Anchorage Alaska, 98508, 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
Mercy Hospital Fort Smith
Fort Smith Arkansas, 72903, United States
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs Arkansas, 71913, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank California, 91505, United States
VA Palo Alto Health Care System
Palo Alto California, 94304, United States
Penrose-Saint Francis Healthcare
Colorado Springs Colorado, 80907, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs Colorado, 80907, United States
Porter Adventist Hospital
Denver Colorado, 80210, United States
Saint Anthony Hospital
Lakewood Colorado, 80228, United States
Littleton Adventist Hospital
Littleton Colorado, 80122, United States
Longmont United Hospital
Longmont Colorado, 80501, United States
Parker Adventist Hospital
Parker Colorado, 80138, United States
Saint Mary Corwin Medical Center
Pueblo Colorado, 81004, United States
Beebe South Coastal Health Campus
Frankford Delaware, 19945, United States
Helen F Graham Cancer Center
Newark Delaware, 19713, United States
Medical Oncology Hematology Consultants PA
Newark Delaware, 19713, United States
Beebe Health Campus
Rehoboth Beach Delaware, 19971, United States
Sibley Memorial Hospital
Washington District of Columbia, 20016, United States
Holy Cross Hospital
Fort Lauderdale Florida, 33308, United States
Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
Emory University Hospital Midtown
Atlanta Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute
Atlanta Georgia, 30322, 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
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 Luke's Cancer Institute - Nampa
Nampa Idaho, 83686, United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa Idaho, 83687, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls Idaho, 83854, United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls Idaho, 83301, United States
Rush - Copley Medical Center
Aurora Illinois, 60504, 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
Northwestern University
Chicago Illinois, 60611, United States
Carle at The Riverfront
Danville Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur Illinois, 62526, United States
Decatur Memorial Hospital
Decatur Illinois, 62526, United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb Illinois, 60115, United States
Carle Physician Group-Effingham
Effingham Illinois, 62401, 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
Northwestern Medicine Cancer Center Delnor
Geneva Illinois, 60134, United States
Edward Hines Jr VA Hospital
Hines Illinois, 60141, United States
Illinois CancerCare-Kewanee Clinic
Kewanee Illinois, 61443, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest Illinois, 60045, United States
Illinois CancerCare-Macomb
Macomb Illinois, 61455, United States
Carle Physician Group-Mattoon/Charleston
Mattoon Illinois, 61938, United States
Loyola University Medical Center
Maywood Illinois, 60153, United States
Good Samaritan Regional Health Center
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
OSF Saint Francis Radiation Oncology at Pekin
Pekin Illinois, 61554, United States
Illinois CancerCare-Peoria
Peoria Illinois, 61615, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria Illinois, 61636, United States
OSF Saint Francis Medical Center
Peoria Illinois, 61637, 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
Memorial Medical Center
Springfield Illinois, 62781, United States
Carle Cancer Center
Urbana Illinois, 61801, United States
The Carle Foundation Hospital
Urbana Illinois, 61801, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville Illinois, 60555, United States
Mary Greeley Medical Center
Ames Iowa, 50010, United States
McFarland Clinic - Ames
Ames Iowa, 50010, United States
Mercy Cancer Center-West Lakes
Clive Iowa, 50325, United States
Mission Cancer and Blood - West Des Moines
Clive Iowa, 50325, United States
Greater Regional Medical Center
Creston Iowa, 50801, United States
Iowa Methodist Medical Center
Des Moines Iowa, 50309, United States
Mission Cancer and Blood - Des Moines
Des Moines Iowa, 50309, United States
Broadlawns Medical Center
Des Moines Iowa, 50314, United States
Mercy Medical Center - Des Moines
Des Moines Iowa, 50314, United States
Mission Cancer and Blood - Laurel
Des Moines Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines Iowa, 50316, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City Iowa, 52242, United States
Methodist West Hospital
West Des Moines Iowa, 50266, United States
Mercy Medical Center-West Lakes
West Des Moines Iowa, 50266, United States
Saint Joseph Radiation Oncology Resource Center
Lexington Kentucky, 40504, United States
Saint Joseph Hospital East
Lexington Kentucky, 40509, United States
Jewish Hospital
Louisville Kentucky, 40202, United States
Baptist Health Louisville
Louisville Kentucky, 40207, United States
UofL Health Medical Center Northeast
Louisville Kentucky, 40245, 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
Eastern Maine Medical Center
Bangor Maine, 04401, United States
Lafayette Family Cancer Center-EMMC
Brewer Maine, 04412, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore Maryland, 21287, United States
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor Michigan, 48106, 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
Chelsea Hospital
Chelsea Michigan, 48118, United States
Ascension Saint John Hospital
Detroit Michigan, 48236, United States
Genesys Hurley Cancer Institute
Flint Michigan, 48503, United States
Hurley Medical Center
Flint Michigan, 48503, United States
University of Michigan Health - Sparrow Lansing
Lansing Michigan, 48912, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia Michigan, 48154, United States
Michigan Healthcare Professionals Pontiac
Pontiac Michigan, 48341, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac Michigan, 48341, United States
Ascension Saint Mary's Hospital
Saginaw Michigan, 48601, United States
Saint John Macomb-Oakland Hospital
Warren Michigan, 48093, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti Michigan, 48197, United States
Essentia Health Saint Joseph's Medical Center
Brainerd Minnesota, 56401, United States
Mercy Hospital
Coon Rapids Minnesota, 55433, United States
Essentia Health - Deer River Clinic
Deer River Minnesota, 56636, United States
Essentia Health Cancer Center
Duluth Minnesota, 55805, United States
Essentia Health Saint Mary's Medical Center
Duluth Minnesota, 55805, United States
Miller-Dwan Hospital
Duluth Minnesota, 55805, United States
Unity Hospital
Fridley Minnesota, 55432, United States
Essentia Health Hibbing Clinic
Hibbing Minnesota, 55746, United States
Essentia Health Sandstone
Sandstone Minnesota, 55072, United States
Essentia Health Virginia Clinic
Virginia Minnesota, 55792, United States
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin Missouri, 63011, United States
Saint Francis Medical Center
Cape Girardeau Missouri, 63703, United States
Southeast Cancer Center
Cape Girardeau Missouri, 63703, United States
Siteman Cancer Center at West County Hospital
Creve Coeur Missouri, 63141, United States
Parkland Health Center - Farmington
Farmington Missouri, 63640, United States
MU Health Care Goldschmidt Cancer Center
Jefferson City Missouri, 65109, United States
Mercy Hospital Joplin
Joplin Missouri, 64804, United States
Delbert Day Cancer Institute at PCRMC
Rolla Missouri, 65401, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla Missouri, 65401, United States
Heartland Regional Medical Center
Saint Joseph Missouri, 64506, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Mercy Hospital South
Saint Louis Missouri, 63128, United States
Siteman Cancer Center-South County
Saint Louis Missouri, 63129, United States
Missouri Baptist Medical Center
Saint Louis Missouri, 63131, United States
Siteman Cancer Center at Christian Hospital
Saint Louis Missouri, 63136, United States
Mercy Hospital Saint Louis
Saint Louis Missouri, 63141, United States
Siteman Cancer Center at Saint Peters Hospital
Saint Peters Missouri, 63376, 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
Billings Clinic Cancer Center
Billings Montana, 59101, United States
Bozeman Health Deaconess Hospital
Bozeman Montana, 59715, United States
Benefis Sletten Cancer Institute
Great Falls Montana, 59405, United States
Great Falls Clinic
Great Falls Montana, 59405, United States
Kalispell Regional Medical Center
Kalispell Montana, 59901, United States
Community Medical Center
Missoula Montana, 59804, United States
Nebraska Cancer Specialists/Oncology Hematology West PC
Grand Island Nebraska, 68803, United States
CHI Health Good Samaritan
Kearney Nebraska, 68847, United States
Alegent Health Immanuel Medical Center
Omaha Nebraska, 68122, United States
Alegent Health Bergan Mercy Medical Center
Omaha Nebraska, 68124, United States
Alegent Health Lakeside Hospital
Omaha Nebraska, 68130, United States
Creighton University Medical Center
Omaha Nebraska, 68131, United States
University of New Mexico Cancer Center
Albuquerque New Mexico, 87106, United States
Good Samaritan Hospital - Cincinnati
Cincinnati Ohio, 45220, United States
Bethesda North Hospital
Cincinnati Ohio, 45242, United States
Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, 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 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
Providence Portland Medical Center
Portland Oregon, 97213, United States
Providence Saint Vincent Medical Center
Portland Oregon, 97225, United States
Lehigh Valley Hospital-Cedar Crest
Allentown Pennsylvania, 18103, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem Pennsylvania, 18017, United States
Christiana Care Health System-Concord Health Center
Chadds Ford Pennsylvania, 19317, United States
Pocono Medical Center
East Stroudsburg Pennsylvania, 18301, United States
Penn State Milton S Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Gibbs Cancer Center-Gaffney
Gaffney South Carolina, 29341, United States
Gibbs Cancer Center-Pelham
Greer South Carolina, 29651, United States
Spartanburg Medical Center
Spartanburg South Carolina, 29303, United States
MGC Hematology Oncology-Union
Union South Carolina, 29379, United States
University of Tennessee - Knoxville
Knoxville Tennessee, 37920, United States
Saint Joseph Regional Cancer Center
Bryan Texas, 77802, United States
Sovah Health Martinsville
Martinsville Virginia, 24112, United States
Providence Regional Cancer System-Aberdeen
Aberdeen Washington, 98520, United States
PeaceHealth Saint Joseph Medical Center
Bellingham Washington, 98225, United States
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton Washington, 98310, United States
Highline Medical Center-Main Campus
Burien Washington, 98166, 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
Swedish Cancer Institute-Issaquah
Issaquah Washington, 98029, United States
Providence Regional Cancer System-Lacey
Lacey Washington, 98503, United States
PeaceHealth Saint John Medical Center
Longview Washington, 98632, United States
Swedish Medical Center-Ballard Campus
Seattle Washington, 98107, United States
Swedish Medical Center-First Hill
Seattle Washington, 98122, United States
PeaceHealth United General Medical Center
Sedro-Woolley Washington, 98284, United States
Saint Michael Cancer Center
Silverdale Washington, 98383, United States
PeaceHealth Southwest Medical Center
Vancouver Washington, 98664, United States
Providence Saint Mary Regional Cancer Center
Walla Walla Washington, 99362, United States
Duluth Clinic Ashland
Ashland Wisconsin, 54806, United States
Northwest Wisconsin Cancer Center
Ashland Wisconsin, 54806, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire Wisconsin, 54701, United States
Marshfield Medical Center-Marshfield
Marshfield Wisconsin, 54449, United States
Marshfield Clinic-Minocqua Center
Minocqua Wisconsin, 54548, 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
Marshfield Medical Center - Weston
Weston Wisconsin, 54476, United States
Welch Cancer Center
Sheridan Wyoming, 82801, United States

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

95

Study ID:

NCT04216290

Recruitment Status:

Active, not recruiting

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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