Bladder Cancer Clinical Trial

Testing the Addition of the Anti-cancer Drug, Cabozantinib, to the Usual Immunotherapy Treatment, Avelumab, in Patients With Metastatic Urothelial Cancer, MAIN-CAV Study

Summary

This phase III trial compares the effect of adding cabozantinib to avelumab versus avelumab alone in treating patients with urothelial cancer that has spread to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and avelumab together may further shrink the cancer or prevent it from returning/progressing.

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Full Description

PRIMARY OBJECTIVE:

I. To evaluate the effect of cabozantinib S-malate (cabozantinib) in combination with avelumab on overall survival (OS) compared to avelumab alone in patients with metastatic urothelial cancer (mUC) who did not progress during first-line platinum-based chemotherapy therapy, i.e. patients who had complete response (CR), partial response (PR) or stable disease (SD) after completion of first line platinum-based chemotherapy.

SECONDARY OBJECTIVES:

I. To evaluate the effect of cabozantinib in combination with avelumab on progression-free survival (PFS) compared to avelumab alone for maintenance treatment following initial first-line treatment in patients who had a CR, PR or SD upon completion of first-line platinum-based chemotherapy.

II. To evaluate the safety and tolerability of cabozantinib in combination with avelumab in mUC compared to avelumab alone for maintenance treatment following initial first-line treatment in patients who had a CR, PR or SD upon completion of first-line platinum-based chemotherapy.

III. To evaluate activity of cabozantinib in combination with avelumab based on Response Evaluation Criteria in Solid Tumors (RECIST) compared to avelumab alone for maintenance treatment following initial first-line treatment in patients who had a CR, PR or SD upon completion of first-line platinum-based chemotherapy.

IV. Results of the primary analysis will be examined for consistency, while accounting for the stratification factors and/or covariates of baseline quality of life (QOL) and fatigue.

V. To evaluate the activity of cabozantinib in combination with avelumab compared to avelumab alone based on PD-L1 status of patients' tumors.

QUALITY OF LIFE (QOL) OBJECTIVES:

I. To compare quality-adjusted survival between patients randomized to receive cabozantinib and avelumab versus (vs.) avelumab alone using the European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L).

II. To compare patient-reported fatigue as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 4a from baseline through 12 months between patients randomized to receive cabozantinib and avelumab vs. avelumab alone.

III. To compare patient-reported global health status/quality of life as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core (C)30 from baseline through 12 months between patients randomized to receive cabozantinib and avelumab vs. avelumab alone.

IV. To compare scale scores of the EORTC QLQ-Bladder Cancer Muscle-Invasive (BLM)30 (urinary symptoms, urostomy problems, catheter problems, future perspectives, abdominal bloating and flatulence, body image, sexual function) at 3, 6, 12, 18, and 24 months between patients randomized to receive cabozantinib and avelumab vs. avelumab alone.

V. To compare scale scores of the EORTC QLQ-C30 (global health status/quality of life; physical, role, emotional, cognitive, and social function; symptoms) at 3, 6, 12, 18, and 24 months between patients randomized to receive cabozantinib and avelumab vs. avelumab alone.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive avelumab intravenously (IV) over 60 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days for 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo bone scan at screening and undergo computed tomography (CT) or magnetic resonance imaging (MRI) and biospecimen collection throughout the trial.

ARM B: Patients receive avelumab IV over 60 minutes on days 1 and 15 of each cycle and cabozantinib orally (PO) daily on days 1-28 of each cycle. Cycles repeat every 28 days for 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo bone scan at screening and undergo CT or MRI and biospecimen collection throughout the trial.

After completion of study treatment, patients are followed every 30 days through 90 days, then every 3 months for 5 years.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically-confirmed diagnosis of advanced or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra (transitional cell and mixed transitional/non-transitional cell histologies except for small-cell histology), including N3 only disease prior to start of first-line platinum-based chemotherapy
Prior first-line treatment must have consisted of 4-6 cycles of 1st-line therapy (platinum-based chemotherapy; gemcitabine-cisplatin, gemcitabine-carboplatin, methotrexate, vinblastine, doxorubicin and cisplatin [MVAC] or dose-dense [dd]MVAC)
No more than 1 line of prior chemotherapy for metastatic or locally advanced disease (neoadjuvant or adjuvant chemotherapy will be allowed if given 12 or more months prior to registration)
Tumor objective response of CR, PR, or SD upon completion of first line platinum-based chemotherapy by treating physician's assessment
The last dose of first-line chemotherapy must have been received no less than 3 weeks, and no more than 10 weeks, prior to randomization in the present study
No prior immunotherapy with IL-2, IFN-alpha, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA-4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
Age >= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects

Women of childbearing potential must have a negative pregnancy test =< 14 days prior to registration.

Women of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal. Post menopause is defined as amenorrhea >= 12 consecutive months. Note: women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, ovarian suppression or any other reversible reason

No use of immunosuppressive medication within 7 days prior to randomization except:

Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection);
Systemic corticosteroids at physiologic doses =< 10 mg/day of prednisone or equivalent;
Steroids as premedication for hypersensitivity reactions (e.g., computed tomography [CT] scan premedication)
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
Patients with diabetes type I, vitiligo, psoriasis, or hypo or hyperthyroid disease not requiring immunosuppressive treatment are eligible

None of the following:

Active autoimmune disease that might deteriorate when receiving the anti PD-L1 agent, avelumab.
No known symptomatic central nervous system (CNS) metastases. Patients with previously diagnosed CNS metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to randomization, have discontinued corticosteroid treatment for at least 2 weeks, and are neurologically stable. Baseline brain imaging with contrast-enhanced CT or MRI scans for subjects with known brain metastases is required to confirm eligibility.
No major surgery within 4 weeks prior to randomization. Subjects must have complete wound healing from surgery before randomization. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.
No palliative radiotherapy within 48 hours prior to patient randomization.
No hemoptysis of ≥ 0.5 teaspoon (2.5 mL) of red blood, clinically significant hematuria, hematemesis, coagulopathy, or other history of significant bleeding (eg. Pulmonary hemorrhage) within 3 months before randomization.
No known cavitating pulmonary lesion(s) or known endobronchial disease manifestation.
No administration of a live, attenuated vaccine within 30 days prior to randomization. The use of inactivated (killed) vaccines for the prevention of infectious disease is permitted. The use of COVID-19 vaccines is permitted.

No uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:

Cardiovascular disorders including:

Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening.
Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic, or > 90 mm Hg diastolic despite optimal antihypertensive treatment.
The patient has a known history of corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms and confirmed by electrocardiogram (ECG) within 28 days before randomization. Note: if initial QTcF is found to be > 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed. If the average of these three consecutive results for QTcF is ≤ 500 ms, the subject meets eligibility in this regard.
Any history of congenital long QT syndrome.
Stroke, transient ischemic attack (TIA), myocardial infarction, or other symptomatic ischemic event or thromboembolic event (eg, deep venous thrombosis, pulmonary embolism [DVT/PE]) within 6 months before randomization. Subjects with a diagnosis of incidental, subsegmental PE or DVT within 6 months are allowed if asymptomatic and stable at screening and treated with low molecular weight heparin (LMWH) or the direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban for at least 1 week before randomization. Non-symptomatic white matter disease in the brain is acceptable.
No significant gastrointestinal disorders, particularly those associated with a high risk of perforation or fistula formation including unresolved active peptic ulcer disease, cholecystitis, diverticultis, symptomatic cholangitis or appendicitis, or malabsorption syndrome within 28 days of randomization.

No other clinically significant disorders such as:

Any active infection requiring systemic treatment within 14 days before randomization. Subjects receiving oral (including prophylactic) antibiotics with no symptoms of infection at randomization are eligible.
Serious non-healing wound/ulcer/bone fracture within 28 days before randomization
History of organ or allogeneic stem cell transplant
No persisting toxicity related to prior therapy grade > 2 constituting a safety risk based on the investigator's judgment.
No diagnosis of any other malignancy within 3 years prior to randomization, except for locally curable cancers that have been adequately treated such as basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix, Gleason < 7 prostate cancer on surveillance without any plans for treatment intervention (eg, surgery, radiation, or castration), or prostate cancer that has been adequately treated with prostatectomy or radiotherapy and currently with no evidence of disease or symptoms and no indication for treatment.

No concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel).

Allowed anticoagulants are the following:

Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor
Absolute neutrophil count (ANC) >= 1,000/mm^3
Platelet count >= 100,000/mm^3
Hemoglobin >= 8 g/dL
Calculated (Calc.) creatinine clearance >= 30 mL/min using the Cockcroft-Gault equation
Total serum bilirubin =< 1.5 x upper limit of normal (ULN)
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN (or =< 5 x ULN for patients with liver metastases or Gilbert's disease)
Urine protein creatinine (UPC) ratio =< 1 or 24-hour protein < 1 g

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.
Uncontrolled medical conditions which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
Patients who cannot swallow oral formulations of the agent(s).

In addition:

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).
Patients with rheumatoid arthritis and other rheumatologic arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and or steroids equivalent to < 10 mg prednisone daily, not on immunosuppressive medications and patients with positive serology are eligible. Patients with vitiligo, endocrine deficiencies including hypo or hyper thyroid disease managed with replacement, diabetes type 1 are eligible.
Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the study and continue for 4 months after the last dose of study drugs, even if oral contraceptives are also used.

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

654

Study ID:

NCT05092958

Recruitment Status:

Active, not recruiting

Sponsor:

National Cancer Institute (NCI)

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There are 244 Locations for this study

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Mayo Clinic Hospital in Arizona
Phoenix Arizona, 85054, United States
Sutter Auburn Faith Hospital
Auburn California, 95602, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley California, 94704, United States
Palo Alto Medical Foundation-Fremont
Fremont California, 94538, United States
Memorial Medical Center
Modesto California, 95355, United States
Palo Alto Medical Foundation-Camino Division
Mountain View California, 94040, United States
Palo Alto Medical Foundation Health Care
Palo Alto California, 94301, United States
Sutter Roseville Medical Center
Roseville California, 95661, United States
Sutter Medical Center Sacramento
Sacramento California, 95816, United States
University of California Davis Comprehensive Cancer Center
Sacramento California, 95817, United States
California Pacific Medical Center-Pacific Campus
San Francisco California, 94115, United States
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz California, 95065, United States
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale California, 94086, United States
Sutter Solano Medical Center/Cancer Center
Vallejo California, 94589, 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
MedStar Washington Hospital Center
Washington District of Columbia, 20010, United States
University of Florida Health Science Center - Gainesville
Gainesville Florida, 32610, United States
Mayo Clinic in Florida
Jacksonville Florida, 32224, United States
Cleveland Clinic-Weston
Weston Florida, 33331, United States
Rush - Copley Medical Center
Aurora Illinois, 60504, United States
Advocate Good Shepherd Hospital
Barrington Illinois, 60010, United States
Illinois CancerCare-Bloomington
Bloomington Illinois, 61704, United States
Illinois CancerCare-Canton
Canton Illinois, 61520, 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
Rush University Medical Center
Chicago Illinois, 60612, United States
University of Illinois
Chicago Illinois, 60612, United States
Advocate Illinois Masonic Medical Center
Chicago Illinois, 60657, United States
AMG Crystal Lake - Oncology
Crystal Lake Illinois, 60014, United States
Carle at The Riverfront
Danville Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur Illinois, 62526, United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb Illinois, 60115, United States
Illinois CancerCare-Dixon
Dixon Illinois, 61021, United States
Advocate Good Samaritan Hospital
Downers Grove Illinois, 60515, United States
Carle Physician Group-Effingham
Effingham Illinois, 62401, United States
Crossroads Cancer Center
Effingham Illinois, 62401, United States
Advocate Sherman Hospital
Elgin Illinois, 60123, United States
Illinois CancerCare-Eureka
Eureka Illinois, 61530, United States
Illinois CancerCare-Galesburg
Galesburg Illinois, 61401, United States
Northwestern Medicine Cancer Center Delnor
Geneva Illinois, 60134, United States
Advocate South Suburban Hospital
Hazel Crest Illinois, 60429, United States
Illinois CancerCare-Kewanee Clinic
Kewanee Illinois, 61443, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest Illinois, 60045, United States
AMG Libertyville - Oncology
Libertyville Illinois, 60048, United States
Condell Memorial Hospital
Libertyville Illinois, 60048, United States
Illinois CancerCare-Macomb
Macomb Illinois, 61455, United States
Carle Physician Group-Mattoon/Charleston
Mattoon Illinois, 61938, United States
Cancer Care Center of O'Fallon
O'Fallon Illinois, 62269, United States
Advocate Christ Medical Center
Oak Lawn Illinois, 60453, United States
Illinois CancerCare-Ottawa Clinic
Ottawa Illinois, 61350, United States
Advocate Lutheran General Hospital
Park Ridge Illinois, 60068, United States
Illinois CancerCare-Pekin
Pekin Illinois, 61554, United States
Illinois CancerCare-Peoria
Peoria Illinois, 61615, United States
Illinois CancerCare-Peru
Peru Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton Illinois, 61356, United States
UW Health Carbone Cancer Center Rockford
Rockford Illinois, 61114, United States
Memorial Hospital East
Shiloh Illinois, 62269, 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
Northwestern Medicine Cancer Center Warrenville
Warrenville Illinois, 60555, United States
Illinois CancerCare - Washington
Washington Illinois, 61571, United States
Rush-Copley Healthcare Center
Yorkville Illinois, 60560, United States
Northwest Cancer Center - Main Campus
Crown Point Indiana, 46307, United States
Northwest Oncology LLC
Dyer Indiana, 46311, United States
Northwest Cancer Center - Hobart
Hobart Indiana, 46342, United States
Saint Mary Medical Center
Hobart Indiana, 46342, United States
Saint Catherine Hospital
Indianapolis Indiana, 46312, United States
The Community Hospital
Munster Indiana, 46321, United States
Women's Diagnostic Center - Munster
Munster Indiana, 46321, United States
Northwest Cancer Center - Valparaiso
Valparaiso Indiana, 46383, United States
Mary Greeley Medical Center
Ames Iowa, 50010, United States
McFarland Clinic - Ames
Ames Iowa, 50010, United States
McFarland Clinic - Boone
Boone Iowa, 50036, United States
McFarland Clinic - Trinity Cancer Center
Fort Dodge Iowa, 50501, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City Iowa, 52242, United States
McFarland Clinic - Jefferson
Jefferson Iowa, 50129, United States
McFarland Clinic - Marshalltown
Marshalltown Iowa, 50158, United States
Baptist Health Louisville
Louisville Kentucky, 40207, United States
Harold Alfond Center for Cancer Care
Augusta Maine, 04330, United States
National Institutes of Health Clinical Center
Bethesda Maryland, 20892, United States
UMass Memorial Medical Center - University Campus
Worcester Massachusetts, 01655, 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
Saint Joseph Mercy Chelsea
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
Genesee Cancer and Blood Disease Treatment Center
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
Trinity Health Grand Rapids Hospital
Grand Rapids Michigan, 49503, 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
University of Michigan Health - Sparrow Lansing
Lansing Michigan, 48912, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia Michigan, 48154, United States
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb Michigan, 48044, United States
Trinity Health Muskegon Hospital
Muskegon Michigan, 49444, 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
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph Michigan, 49085, United States
Munson Medical Center
Traverse City Michigan, 49684, 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
Sanford Joe Lueken Cancer Center
Bemidji Minnesota, 56601, United States
Abbott-Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis Minnesota, 55415, United States
Mayo Clinic in Rochester
Rochester Minnesota, 55905, United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud Minnesota, 56303, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park Minnesota, 55416, United States
Regions Hospital
Saint Paul Minnesota, 55101, United States
Rice Memorial Hospital
Willmar Minnesota, 56201, United States
Saint Francis Medical Center
Cape Girardeau Missouri, 63703, United States
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia Missouri, 65212, United States
Siteman Cancer Center at West County Hospital
Creve Coeur Missouri, 63141, United States
Saint Luke's Hospital of Kansas City
Kansas City Missouri, 64111, United States
Saint Luke's East - Lee's Summit
Lee's Summit Missouri, 64086, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Siteman Cancer Center-South County
Saint Louis Missouri, 63129, 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
OptumCare Cancer Care at Seven Hills
Henderson Nevada, 89052, United States
OptumCare Cancer Care at Charleston
Las Vegas Nevada, 89102, United States
OptumCare Cancer Care at Fort Apache
Las Vegas Nevada, 89148, United States
New Hampshire Oncology Hematology PA-Concord
Concord New Hampshire, 03301, United States
Solinsky Center for Cancer Care
Manchester New Hampshire, 03103, 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
Morristown Medical Center
Morristown New Jersey, 07960, United States
Saint Joseph's Regional Medical Center
Paterson New Jersey, 07503, United States
Overlook Hospital
Summit New Jersey, 07902, United States
University of New Mexico Cancer Center
Albuquerque New Mexico, 87106, United States
Memorial Medical Center - Las Cruces
Las Cruces New Mexico, 88011, 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
Glens Falls Hospital
Glens Falls New York, 12801, United States
Memorial Sloan Kettering Westchester
Harrison New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Upstate Cancer Center at Oswego
Oswego New York, 13126, United States
Stony Brook University Medical Center
Stony Brook New York, 11794, United States
State University of New York Upstate Medical University
Syracuse New York, 13210, United States
SUNY Upstate Medical Center-Community Campus
Syracuse New York, 13215, United States
Memorial Sloan Kettering Nassau
Uniondale New York, 11553, United States
Upstate Cancer Center at Verona
Verona New York, 13478, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte North Carolina, 28203, United States
Levine Cancer Institute-SouthPark
Charlotte North Carolina, 28211, United States
Atrium Health University City/LCI-University
Charlotte North Carolina, 28262, United States
Levine Cancer Institute-Ballantyne
Charlotte North Carolina, 28277, United States
Southeastern Medical Oncology Center-Clinton
Clinton North Carolina, 28328, United States
Atrium Health Cabarrus/LCI-Concord
Concord North Carolina, 28025, United States
Southeastern Medical Oncology Center-Goldsboro
Goldsboro North Carolina, 27534, United States
Southeastern Medical Oncology Center-Jacksonville
Jacksonville North Carolina, 28546, United States
Atrium Health Lincoln/LCI-Lincolnton
Lincolnton North Carolina, 28092, United States
Atrium Health Cleveland/LCI-Cleveland
Shelby North Carolina, 28150, United States
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States
Sanford Bismarck Medical Center
Bismarck North Dakota, 58501, United States
Sanford Broadway Medical Center
Fargo North Dakota, 58122, United States
Sanford Roger Maris Cancer Center
Fargo North Dakota, 58122, United States
Cleveland Clinic Akron General
Akron Ohio, 44307, United States
Miami Valley Hospital South
Centerville Ohio, 45459, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland Ohio, 44111, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
Premier Blood and Cancer Center
Dayton Ohio, 45409, United States
Dayton Physician LLC - Englewood
Dayton Ohio, 45415, United States
Miami Valley Hospital North
Dayton Ohio, 45415, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin Ohio, 45005, United States
Miami Valley Cancer Care and Infusion
Greenville Ohio, 45331, United States
Kettering Medical Center
Kettering Ohio, 45429, United States
Cleveland Clinic Cancer Center Mansfield
Mansfield Ohio, 44906, United States
Hillcrest Hospital Cancer Center
Mayfield Heights Ohio, 44124, United States
North Coast Cancer Care
Sandusky Ohio, 44870, United States
Cleveland Clinic Cancer Center Strongsville
Strongsville Ohio, 44136, United States
Toledo Clinic Cancer Centers-Toledo
Toledo Ohio, 43623, United States
Upper Valley Medical Center
Troy Ohio, 45373, United States
South Pointe Hospital
Warrensville Heights Ohio, 44122, United States
Cleveland Clinic Wooster Family Health and Surgery Center
Wooster Ohio, 44691, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa Oklahoma, 74146, United States
Legacy Mount Hood Medical Center
Gresham Oregon, 97030, United States
Legacy Good Samaritan Hospital and Medical Center
Portland Oregon, 97210, United States
Legacy Meridian Park Hospital
Tualatin Oregon, 97062, United States
Lehigh Valley Hospital-Cedar Crest
Allentown Pennsylvania, 18103, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem Pennsylvania, 18017, United States
Penn State Health Medical Group - Andrews Patel Hematology/Oncology East
Harrisburg Pennsylvania, 17111, United States
Penn State Milton S Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States
Jefferson Methodist Hospital
Philadelphia Pennsylvania, 19148, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs South Carolina, 29316, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Prisma Health Cancer Institute - Easley
Easley South Carolina, 29640, United States
Prisma Health Cancer Institute - Butternut
Greenville South Carolina, 29605, United States
Prisma Health Cancer Institute - Faris
Greenville South Carolina, 29605, United States
Prisma Health Greenville Memorial Hospital
Greenville South Carolina, 29605, United States
Prisma Health Cancer Institute - Eastside
Greenville South Carolina, 29615, United States
Prisma Health Cancer Institute - Greer
Greer South Carolina, 29650, United States
Levine Cancer Institute-Rock Hill
Rock Hill South Carolina, 29732, United States
Prisma Health Cancer Institute - Seneca
Seneca South Carolina, 29672, United States
Avera Cancer Institute-Aberdeen
Aberdeen South Dakota, 57401, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls South Dakota, 57104, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls South Dakota, 57117, United States
Avera Cancer Institute at Yankton
Yankton South Dakota, 57078, United States
University Cancer Specialists - Alcoa
Alcoa Tennessee, 37701, United States
University of Tennessee - Knoxville
Knoxville Tennessee, 37920, United States
UT Southwestern Simmons Cancer Center - RedBird
Dallas Texas, 75237, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas Texas, 75390, United States
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth Texas, 76104, United States
UT Southwestern Clinical Center at Richardson/Plano
Richardson Texas, 75080, United States
Bon Secours Memorial Regional Medical Center
Mechanicsville Virginia, 23116, United States
Bon Secours Saint Francis Medical Center
Midlothian Virginia, 23114, United States
Bon Secours Saint Mary's Hospital
Richmond Virginia, 23226, United States
Virginia Cancer Institute
Richmond Virginia, 23229, United States
VCU Massey Cancer Center at Stony Point
Richmond Virginia, 23235, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond Virginia, 23298, United States
VCU Community Memorial Health Center
South Hill Virginia, 23970, United States
Shenandoah Oncology PC
Winchester Virginia, 22601, United States
Valley Medical Center
Renton Washington, 98055, United States
Legacy Cancer Institute Medical Oncology and Day Treatment
Vancouver Washington, 98684, United States
Legacy Salmon Creek Hospital
Vancouver Washington, 98686, United States
West Virginia University Charleston Division
Charleston West Virginia, 25304, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington Wisconsin, 53105, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire Wisconsin, 54701, United States
Aurora Health Care Germantown Health Center
Germantown Wisconsin, 53022, United States
Aurora Cancer Care-Grafton
Grafton Wisconsin, 53024, United States
Aurora BayCare Medical Center
Green Bay Wisconsin, 54311, United States
Aurora Cancer Care-Kenosha South
Kenosha Wisconsin, 53142, United States
Aurora Bay Area Medical Group-Marinette
Marinette Wisconsin, 54143, United States
Marshfield Medical Center-Marshfield
Marshfield Wisconsin, 54449, United States
Froedtert Menomonee Falls Hospital
Menomonee Falls Wisconsin, 53051, United States
Aurora Cancer Care-Milwaukee
Milwaukee Wisconsin, 53209, United States
Aurora Saint Luke's Medical Center
Milwaukee Wisconsin, 53215, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Aurora Sinai Medical Center
Milwaukee Wisconsin, 53233, United States
Marshfield Clinic-Minocqua Center
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
Drexel Town Square Health Center
Oak Creek Wisconsin, 53154, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc Wisconsin, 53066, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh Wisconsin, 54904, United States
Aurora Cancer Care-Racine
Racine Wisconsin, 53406, United States
Marshfield Medical Center-Rice Lake
Rice Lake Wisconsin, 54868, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan Wisconsin, 53081, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point Wisconsin, 54482, United States
Aurora Medical Center in Summit
Summit Wisconsin, 53066, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers Wisconsin, 54241, United States
ProHealth Waukesha Memorial Hospital
Waukesha Wisconsin, 53188, United States
UW Cancer Center at ProHealth Care
Waukesha Wisconsin, 53188, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa Wisconsin, 53226, United States
Aurora West Allis Medical Center
West Allis Wisconsin, 53227, United States
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend Wisconsin, 53095, United States
Marshfield Medical Center - Weston
Weston Wisconsin, 54476, United States
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
University Health Network-Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada
Allan Blair Cancer Centre
Regina Saskatchewan, S4T 7, Canada
Saskatoon Cancer Centre
Saskatoon Saskatchewan, S7N 4, Canada

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

654

Study ID:

NCT05092958

Recruitment Status:

Active, not recruiting

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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