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.

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.

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
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: (140 - age) × weight (kg)/(serum creatinine [mg/dL] × 72)
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

Exclusion Criteria:

Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
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 magnetic resonance imaging (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 (e.g. 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 (e.g., 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, diverticulitis, 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 (e.g., 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

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:

Recruiting

Sponsor:

National Cancer Institute (NCI)

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There are 138 Locations for this study

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Mayo Clinic Hospital in Arizona
Phoenix Arizona, 85054, United States More Info
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855-776-0015
Parminder Singh
Principal Investigator
Sutter Auburn Faith Hospital
Auburn California, 95602, United States More Info
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[email protected]
Uma Suryadevara
Principal Investigator
Alta Bates Summit Medical Center-Herrick Campus
Berkeley California, 94704, United States More Info
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[email protected]
Uma Suryadevara
Principal Investigator
Palo Alto Medical Foundation-Fremont
Fremont California, 94538, United States More Info
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415-209-2683
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Uma Suryadevara
Principal Investigator
Palo Alto Medical Foundation-Camino Division
Mountain View California, 94040, United States More Info
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[email protected]
Uma Suryadevara
Principal Investigator
Palo Alto Medical Foundation Health Care
Palo Alto California, 94301, United States More Info
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[email protected]
Uma Suryadevara
Principal Investigator
Sutter Roseville Medical Center
Roseville California, 95661, United States More Info
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[email protected]
Uma Suryadevara
Principal Investigator
Sutter Medical Center Sacramento
Sacramento California, 95816, United States More Info
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[email protected]
Uma Suryadevara
Principal Investigator
University of California Davis Comprehensive Cancer Center
Sacramento California, 95817, United States More Info
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916-734-3089
Mamta Parikh
Principal Investigator
California Pacific Medical Center-Pacific Campus
San Francisco California, 94115, United States More Info
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[email protected]
Uma Suryadevara
Principal Investigator
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale California, 94086, United States More Info
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415-209-2683
[email protected]
Uma Suryadevara
Principal Investigator
Sutter Solano Medical Center/Cancer Center
Vallejo California, 94589, United States More Info
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[email protected]
Uma Suryadevara
Principal Investigator
Helen F Graham Cancer Center
Newark Delaware, 19713, United States More Info
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302-623-4450
[email protected]
Gregory A. Masters
Principal Investigator
Medical Oncology Hematology Consultants PA
Newark Delaware, 19713, United States More Info
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302-623-4450
[email protected]
Gregory A. Masters
Principal Investigator
University of Florida Health Science Center - Gainesville
Gainesville Florida, 32610, United States More Info
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352-273-8010
[email protected]
Brian H. Ramnaraign
Principal Investigator
Advocate Good Shepherd Hospital
Barrington Illinois, 60010, United States More Info
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847-842-4847
Adam P. Siegel
Principal Investigator
Illinois CancerCare-Bloomington
Bloomington Illinois, 61704, United States More Info
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309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Canton
Canton Illinois, 61520, United States More Info
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309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Carthage
Carthage Illinois, 62321, United States More Info
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309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Centralia Oncology Clinic
Centralia Illinois, 62801, United States
Advocate Illinois Masonic Medical Center
Chicago Illinois, 60657, United States More Info
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773-296-5360
Adam P. Siegel
Principal Investigator
AMG Crystal Lake - Oncology
Crystal Lake Illinois, 60014, United States More Info
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630-929-6129
[email protected]
Adam P. Siegel
Principal Investigator
Carle on Vermilion
Danville Illinois, 61832, United States More Info
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800-446-5532
[email protected]
Tanmay Sahai
Principal Investigator
Cancer Care Specialists of Illinois - Decatur
Decatur Illinois, 62526, United States More Info
Site Public Contact
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217-876-4762
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Dixon
Dixon Illinois, 61021, United States More Info
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815-285-7800
Bryan A. Faller
Principal Investigator
Advocate Good Samaritan Hospital
Downers Grove Illinois, 60515, United States More Info
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630-275-1270
[email protected]
Adam P. Siegel
Principal Investigator
Carle Physician Group-Effingham
Effingham Illinois, 62401, United States More Info
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800-446-5532
[email protected]
Tanmay Sahai
Principal Investigator
Crossroads Cancer Center
Effingham Illinois, 62401, United States More Info
Site Public Contact
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217-876-4762
[email protected]
Bryan A. Faller
Principal Investigator
Advocate Sherman Hospital
Elgin Illinois, 60123, United States More Info
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847-429-2907
Adam P. Siegel
Principal Investigator
Illinois CancerCare-Eureka
Eureka Illinois, 61530, United States More Info
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309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Galesburg
Galesburg Illinois, 61401, United States More Info
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309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Advocate South Suburban Hospital
Hazel Crest Illinois, 60429, United States More Info
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708-799-9995
Adam P. Siegel
Principal Investigator
Illinois CancerCare-Kewanee Clinic
Kewanee Illinois, 61443, United States More Info
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309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
AMG Libertyville - Oncology
Libertyville Illinois, 60048, United States More Info
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630-929-6129
[email protected]
Adam P. Siegel
Principal Investigator
Condell Memorial Hospital
Libertyville Illinois, 60048, United States More Info
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630-929-6129
[email protected]
Adam P. Siegel
Principal Investigator
Illinois CancerCare-Macomb
Macomb Illinois, 61455, United States More Info
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309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Carle Physician Group-Mattoon/Charleston
Mattoon Illinois, 61938, United States More Info
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800-446-5532
[email protected]
Tanmay Sahai
Principal Investigator
Cancer Care Center of O'Fallon
O'Fallon Illinois, 62269, United States More Info
Site Public Contact
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217-876-4762
[email protected]
Bryan A. Faller
Principal Investigator
Advocate Christ Medical Center
Oak Lawn Illinois, 60453, United States More Info
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800-323-8622
Adam P. Siegel
Principal Investigator
Illinois CancerCare-Ottawa Clinic
Ottawa Illinois, 61350, United States More Info
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309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Advocate Lutheran General Hospital
Park Ridge Illinois, 60068, United States More Info
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847-384-3621
Adam P. Siegel
Principal Investigator
Illinois CancerCare-Pekin
Pekin Illinois, 61554, United States More Info
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309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Peoria
Peoria Illinois, 61615, United States More Info
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309-243-3605
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Bryan A. Faller
Principal Investigator
Illinois CancerCare-Peru
Peru Illinois, 61354, United States More Info
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309-243-3605
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Bryan A. Faller
Principal Investigator
Illinois CancerCare-Princeton
Princeton Illinois, 61356, United States More Info
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309-243-3605
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Bryan A. Faller
Principal Investigator
Southern Illinois University School of Medicine
Springfield Illinois, 62702, United States More Info
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217-545-7929
Bryan A. Faller
Principal Investigator
Springfield Clinic
Springfield Illinois, 62702, United States More Info
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800-444-7541
Bryan A. Faller
Principal Investigator
Memorial Medical Center
Springfield Illinois, 62781, United States More Info
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217-528-7541
[email protected]
Bryan A. Faller
Principal Investigator
Carle Cancer Center
Urbana Illinois, 61801, United States More Info
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800-446-5532
[email protected]
Tanmay Sahai
Principal Investigator
Illinois CancerCare - Washington
Washington Illinois, 61571, United States More Info
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309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Mary Greeley Medical Center
Ames Iowa, 50010, United States More Info
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515-956-4132
Debra M. Prow
Principal Investigator
McFarland Clinic PC - Ames
Ames Iowa, 50010, United States More Info
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515-239-4734
[email protected]
Debra M. Prow
Principal Investigator
McFarland Clinic PC-Boone
Boone Iowa, 50036, United States More Info
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515-956-4132
Debra M. Prow
Principal Investigator
McFarland Clinic PC-Trinity Cancer Center
Fort Dodge Iowa, 50501, United States More Info
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515-956-4132
Debra M. Prow
Principal Investigator
McFarland Clinic PC-Jefferson
Jefferson Iowa, 50129, United States More Info
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515-956-4132
Debra M. Prow
Principal Investigator
McFarland Clinic PC-Marshalltown
Marshalltown Iowa, 50158, United States More Info
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515-956-4132
Debra M. Prow
Principal Investigator
Harold Alfond Center for Cancer Care
Augusta Maine, 04330, United States More Info
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207-626-4855
Rachit Kumar
Principal Investigator
Saint Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States More Info
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734-712-7251
[email protected]
Tareq Al Baghdadi
Principal Investigator
Saint Joseph Mercy Brighton
Brighton Michigan, 48114, United States More Info
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734-712-7251
[email protected]
Tareq Al Baghdadi
Principal Investigator
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton Michigan, 48114, United States More Info
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734-712-7251
[email protected]
Tareq Al Baghdadi
Principal Investigator
Saint Joseph Mercy Canton
Canton Michigan, 48188, United States More Info
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734-712-7251
[email protected]
Tareq Al Baghdadi
Principal Investigator
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton Michigan, 48188, United States More Info
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734-712-7251
[email protected]
Tareq Al Baghdadi
Principal Investigator
Saint Joseph Mercy Chelsea
Chelsea Michigan, 48118, United States More Info
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734-712-7251
[email protected]
Tareq Al Baghdadi
Principal Investigator
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea Michigan, 48118, United States More Info
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734-712-7251
[email protected]
Tareq Al Baghdadi
Principal Investigator
Hematology Oncology Consultants-Clarkston
Clarkston Michigan, 48346, United States More Info
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734-712-7251
[email protected]
Tareq Al Baghdadi
Principal Investigator
Newland Medical Associates-Clarkston
Clarkston Michigan, 48346, United States More Info
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734-712-7251
[email protected]
Tareq Al Baghdadi
Principal Investigator
Genesee Cancer and Blood Disease Treatment Center
Flint Michigan, 48503, United States More Info
Site Public Contact
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810-762-8038
[email protected]
Tareq Al Baghdadi
Principal Investigator
Genesee Hematology Oncology PC
Flint Michigan, 48503, United States More Info
Site Public Contact
Contact
810-762-8038
[email protected]
Tareq Al Baghdadi
Principal Investigator
Genesys Hurley Cancer Institute
Flint Michigan, 48503, United States More Info
Site Public Contact
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810-762-8038
[email protected]
Tareq Al Baghdadi
Principal Investigator
Hurley Medical Center
Flint Michigan, 48503, United States More Info
Site Public Contact
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810-762-8038
[email protected]
Tareq Al Baghdadi
Principal Investigator
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia Michigan, 48154, United States More Info
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734-712-7251
[email protected]
Tareq Al Baghdadi
Principal Investigator
21st Century Oncology-Pontiac
Pontiac Michigan, 48341, United States More Info
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Contact
734-712-3671
[email protected]
Tareq Al Baghdadi
Principal Investigator
Hope Cancer Center
Pontiac Michigan, 48341, United States More Info
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734-712-7251
[email protected]
Tareq Al Baghdadi
Principal Investigator
Newland Medical Associates-Pontiac
Pontiac Michigan, 48341, United States More Info
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734-712-7251
[email protected]
Tareq Al Baghdadi
Principal Investigator
Saint Joseph Mercy Oakland
Pontiac Michigan, 48341, United States More Info
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734-712-7251
[email protected]
Tareq Al Baghdadi
Principal Investigator
Huron Gastroenterology PC
Ypsilanti Michigan, 48106, United States More Info
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734-712-7251
[email protected]
Tareq Al Baghdadi
Principal Investigator
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti Michigan, 48197, United States More Info
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734-712-7251
[email protected]
Tareq Al Baghdadi
Principal Investigator
Sanford Joe Lueken Cancer Center
Bemidji Minnesota, 56601, United States More Info
Site Public Contact
Contact
218-333-5000
[email protected]
Preston D. Steen
Principal Investigator
Abbott-Northwestern Hospital
Minneapolis Minnesota, 55407, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
Daniel M. Anderson
Principal Investigator
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud Minnesota, 56303, United States More Info
Site Public Contact
Contact
877-229-4907
[email protected]
Donald J. Jurgens
Principal Investigator
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park Minnesota, 55416, United States More Info
Site Public Contact
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952-993-1517
[email protected]
Daniel M. Anderson
Principal Investigator
Regions Hospital
Saint Paul Minnesota, 55101, United States More Info
Site Public Contact
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952-993-1517
[email protected]
Daniel M. Anderson
Principal Investigator
Saint Francis Medical Center
Cape Girardeau Missouri, 63703, United States More Info
Site Public Contact
Contact
573-334-2230
[email protected]
Bryan A. Faller
Principal Investigator
University of Missouri - Ellis Fischel
Columbia Missouri, 65212, United States More Info
Site Public Contact
Contact
573-882-7440
Kushal Naha
Principal Investigator
Washington University School of Medicine
Saint Louis Missouri, 63110, United States More Info
Site Public Contact
Contact
800-600-3606
[email protected]
Melissa A. Reimers
Principal Investigator
New Hampshire Oncology Hematology PA-Concord
Concord New Hampshire, 03301, United States More Info
Site Public Contact
Contact
603-224-2556
Douglas J. Weckstein
Principal Investigator
Solinsky Center for Cancer Care
Manchester New Hampshire, 03103, United States More Info
Site Public Contact
Contact
800-339-6484
Douglas J. Weckstein
Principal Investigator
Memorial Sloan Kettering Basking Ridge
Basking Ridge New Jersey, 07920, United States More Info
Site Public Contact
Contact
212-639-7592
Min Yuen Teo
Principal Investigator
Memorial Sloan Kettering Monmouth
Middletown New Jersey, 07748, United States More Info
Site Public Contact
Contact
212-639-7592
Min Yuen Teo
Principal Investigator
Memorial Sloan Kettering Bergen
Montvale New Jersey, 07645, United States More Info
Site Public Contact
Contact
212-639-7592
Min Yuen Teo
Principal Investigator
Morristown Medical Center
Morristown New Jersey, 07960, United States
Overlook Hospital
Summit New Jersey, 07902, United States
Memorial Sloan Kettering Commack
Commack New York, 11725, United States More Info
Site Public Contact
Contact
212-639-7592
Min Yuen Teo
Principal Investigator
Glens Falls Hospital
Glens Falls New York, 12801, United States More Info
Site Public Contact
Contact
518-926-6700
John P. Stoutenburg
Principal Investigator
Memorial Sloan Kettering Westchester
Harrison New York, 10604, United States More Info
Site Public Contact
Contact
212-639-7592
Min Yuen Teo
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Site Public Contact
Contact
212-639-7592
Min Yuen Teo
Principal Investigator
Stony Brook University Medical Center
Stony Brook New York, 11794, United States More Info
Site Public Contact
Contact
800-862-2215
Shenhong Wu
Principal Investigator
Memorial Sloan Kettering Nassau
Uniondale New York, 11553, United States More Info
Site Public Contact
Contact
212-639-7592
Min Yuen Teo
Principal Investigator
Southeastern Medical Oncology Center-Clinton
Clinton North Carolina, 28328, United States More Info
Site Public Contact
Contact
919-587-9084
[email protected]
Samer S. Kasbari
Principal Investigator
Southeastern Medical Oncology Center-Goldsboro
Goldsboro North Carolina, 27534, United States More Info
Site Public Contact
Contact
919-587-9084
[email protected]
Samer S. Kasbari
Principal Investigator
Southeastern Medical Oncology Center-Jacksonville
Jacksonville North Carolina, 28546, United States More Info
Site Public Contact
Contact
910-587-9084
[email protected]
Samer S. Kasbari
Principal Investigator
Sanford Bismarck Medical Center
Bismarck North Dakota, 58501, United States More Info
Site Public Contact
Contact
701-323-5760
[email protected]
Preston D. Steen
Principal Investigator
Sanford Broadway Medical Center
Fargo North Dakota, 58122, United States More Info
Site Public Contact
Contact
701-323-5760
[email protected]
Preston D. Steen
Principal Investigator
Sanford Roger Maris Cancer Center
Fargo North Dakota, 58122, United States More Info
Site Public Contact
Contact
701-234-6161
[email protected]
Preston D. Steen
Principal Investigator
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland Ohio, 44111, United States More Info
Site Public Contact
Contact
866-223-8100
[email protected]
Shilpa Gupta
Principal Investigator
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States More Info
Site Public Contact
Contact
866-223-8100
[email protected]
Shilpa Gupta
Principal Investigator
Cleveland Clinic Cancer Center Mansfield
Mansfield Ohio, 44906, United States More Info
Site Public Contact
Contact
866-223-8100
[email protected]
Shilpa Gupta
Principal Investigator
Hillcrest Hospital Cancer Center
Mayfield Heights Ohio, 44124, United States More Info
Site Public Contact
Contact
866-223-8100
[email protected]
Shilpa Gupta
Principal Investigator
North Coast Cancer Care
Sandusky Ohio, 44870, United States More Info
Site Public Contact
Contact
866-223-8100
[email protected]
Shilpa Gupta
Principal Investigator
Cleveland Clinic Cancer Center Strongsville
Strongsville Ohio, 44136, United States More Info
Site Public Contact
Contact
866-223-8100
[email protected]
Shilpa Gupta
Principal Investigator
Toledo Clinic Cancer Centers-Toledo
Toledo Ohio, 43623, United States More Info
Site Public Contact
Contact
800-444-3561
Rex B. Mowat
Principal Investigator
South Pointe Hospital
Warrensville Heights Ohio, 44122, United States More Info
Site Public Contact
Contact
866-223-8100
[email protected]
Shilpa Gupta
Principal Investigator
Cleveland Clinic Wooster Family Health and Surgery Center
Wooster Ohio, 44691, United States More Info
Site Public Contact
Contact
866-223-8100
[email protected]
Shilpa Gupta
Principal Investigator
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States More Info
Site Public Contact
Contact
405-271-8777
[email protected]
Adanma Anji Ayanambakkam Attanathi
Principal Investigator
Legacy Mount Hood Medical Center
Gresham Oregon, 97030, United States More Info
Site Public Contact
Contact
503-413-2150
Mei Dong
Principal Investigator
Legacy Good Samaritan Hospital and Medical Center
Portland Oregon, 97210, United States More Info
Site Public Contact
Contact
800-220-4937
[email protected]
Mei Dong
Principal Investigator
Legacy Meridian Park Hospital
Tualatin Oregon, 97062, United States More Info
Site Public Contact
Contact
503-413-1742
Mei Dong
Principal Investigator
Lehigh Valley Hospital-Cedar Crest
Allentown Pennsylvania, 18103, United States More Info
Site Public Contact
Contact
610-402-9543
[email protected]
Tareq Al Baghdadi
Principal Investigator
Lehigh Valley Hospital - Muhlenberg
Bethlehem Pennsylvania, 18017, United States More Info
Site Public Contact
Contact
610-402-9543
[email protected]
Tareq Al Baghdadi
Principal Investigator
Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States More Info
Site Public Contact
Contact
215-600-9151
[email protected]
William J. Tester
Principal Investigator
Prisma Health Cancer Institute - Spartanburg
Boiling Springs South Carolina, 29316, United States More Info
Site Public Contact
Contact
864-241-6251
Ki Y. Chung
Principal Investigator
Medical University of South Carolina
Charleston South Carolina, 29425, United States More Info
Site Public Contact
Contact
843-792-9321
[email protected]
Theodore S. Gourdin
Principal Investigator
Prisma Health Cancer Institute - Easley
Easley South Carolina, 29640, United States More Info
Site Public Contact
Contact
864-522-2066
Kim.Willia[email protected]
Ki Y. Chung
Principal Investigator
Prisma Health Cancer Institute - Butternut
Greenville South Carolina, 29605, United States More Info
Site Public Contact
Contact
864-241-6251
Ki Y. Chung
Principal Investigator
Prisma Health Cancer Institute - Faris
Greenville South Carolina, 29605, United States More Info
Site Public Contact
Contact
864-241-6251
Ki Y. Chung
Principal Investigator
Prisma Health Greenville Memorial Hospital
Greenville South Carolina, 29605, United States More Info
Site Public Contact
Contact
864-241-6251
Ki Y. Chung
Principal Investigator
Prisma Health Cancer Institute - Eastside
Greenville South Carolina, 29615, United States More Info
Site Public Contact
Contact
864-241-6251
Ki Y. Chung
Principal Investigator
Prisma Health Cancer Institute - Greer
Greer South Carolina, 29650, United States More Info
Site Public Contact
Contact
864-241-6251
Ki Y. Chung
Principal Investigator
Prisma Health Cancer Institute - Seneca
Seneca South Carolina, 29672, United States More Info
Site Public Contact
Contact
864-241-6251
Ki Y. Chung
Principal Investigator
Sanford Cancer Center Oncology Clinic
Sioux Falls South Dakota, 57104, United States More Info
Site Public Contact
Contact
605-312-3320
[email protected]
Preston D. Steen
Principal Investigator
Sanford USD Medical Center - Sioux Falls
Sioux Falls South Dakota, 57117, United States More Info
Site Public Contact
Contact
605-312-3320
[email protected]
Preston D. Steen
Principal Investigator
University of Tennessee - Knoxville
Knoxville Tennessee, 37920, United States More Info
Site Public Contact
Contact
865-544-9773
Saikrishna Gadde
Principal Investigator
Virginia Cancer Institute
Richmond Virginia, 23229, United States More Info
Site Public Contact
Contact
804-287-3000
[email protected]
Asit K. Paul
Principal Investigator
VCU Massey Cancer Center at Stony Point
Richmond Virginia, 23235, United States More Info
Site Public Contact
Contact
[email protected]
Asit K. Paul
Principal Investigator
Virginia Commonwealth University/Massey Cancer Center
Richmond Virginia, 23298, United States More Info
Site Public Contact
Contact
[email protected]
Asit K. Paul
Principal Investigator
VCU Community Memorial Health Center
South Hill Virginia, 23970, United States More Info
Site Public Contact
Contact
434-774-2442
[email protected]
Asit K. Paul
Principal Investigator
Shenandoah Oncology PC
Winchester Virginia, 22601, United States More Info
Site Public Contact
Contact
540-662-1108
[email protected]
Asit K. Paul
Principal Investigator
Legacy Cancer Institute Medical Oncology and Day Treatment
Vancouver Washington, 98684, United States More Info
Site Public Contact
Contact
[email protected]
Mei Dong
Principal Investigator
Legacy Salmon Creek Hospital
Vancouver Washington, 98686, United States More Info
Site Public Contact
Contact
503-413-2150
Mei Dong
Principal Investigator
Aurora Cancer Care-Southern Lakes VLCC
Burlington Wisconsin, 53105, United States More Info
Site Public Contact
Contact
414-302-2304
[email protected]
Adam P. Siegel
Principal Investigator
Aurora Health Care Germantown Health Center
Germantown Wisconsin, 53022, United States More Info
Site Public Contact
Contact
414-302-2304
[email protected]
Adam P. Siegel
Principal Investigator
Aurora Cancer Care-Grafton
Grafton Wisconsin, 53024, United States More Info
Site Public Contact
Contact
414-302-2304
[email protected]
Adam P. Siegel
Principal Investigator
Aurora BayCare Medical Center
Green Bay Wisconsin, 54311, United States More Info
Site Public Contact
Contact
414-302-2304
[email protected]
Adam P. Siegel
Principal Investigator
Aurora Cancer Care-Kenosha South
Kenosha Wisconsin, 53142, United States More Info
Site Public Contact
Contact
414-302-2304
[email protected]
Adam P. Siegel
Principal Investigator
Aurora Bay Area Medical Group-Marinette
Marinette Wisconsin, 54143, United States More Info
Site Public Contact
Contact
414-302-2304
[email protected]
Adam P. Siegel
Principal Investigator
Aurora Cancer Care-Milwaukee
Milwaukee Wisconsin, 53209, United States More Info
Site Public Contact
Contact
414-302-2304
[email protected]
Adam P. Siegel
Principal Investigator
Aurora Saint Luke's Medical Center
Milwaukee Wisconsin, 53215, United States More Info
Site Public Contact
Contact
414-302-2304
[email protected]
Adam P. Siegel
Principal Investigator
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States More Info
Site Public Contact
Contact
414-805-3666
Ariel Nelson
Principal Investigator
Aurora Sinai Medical Center
Milwaukee Wisconsin, 53233, United States More Info
Site Public Contact
Contact
414-302-2304
[email protected]
Adam P. Siegel
Principal Investigator
ProHealth D N Greenwald Center
Mukwonago Wisconsin, 53149, United States More Info
Site Public Contact
Contact
[email protected]
Timothy R. Wassenaar
Principal Investigator
ProHealth Oconomowoc Memorial Hospital
Oconomowoc Wisconsin, 53066, United States More Info
Site Public Contact
Contact
262-928-7878
Timothy R. Wassenaar
Principal Investigator
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh Wisconsin, 54904, United States More Info
Site Public Contact
Contact
414-302-2304
[email protected]
Adam P. Siegel
Principal Investigator
Aurora Cancer Care-Racine
Racine Wisconsin, 53406, United States More Info
Site Public Contact
Contact
414-302-2304
[email protected]
Adam P. Siegel
Principal Investigator
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan Wisconsin, 53081, United States More Info
Site Public Contact
Contact
414-302-2304
[email protected]
Adam P. Siegel
Principal Investigator
Aurora Medical Center in Summit
Summit Wisconsin, 53066, United States More Info
Site Public Contact
Contact
414-302-2304
[email protected]
Adam P. Siegel
Principal Investigator
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers Wisconsin, 54241, United States More Info
Site Public Contact
Contact
414-302-2304
[email protected]
Adam P. Siegel
Principal Investigator
ProHealth Waukesha Memorial Hospital
Waukesha Wisconsin, 53188, United States More Info
Site Public Contact
Contact
262-928-7632
Timothy R. Wassenaar
Principal Investigator
UW Cancer Center at ProHealth Care
Waukesha Wisconsin, 53188, United States More Info
Site Public Contact
Contact
262-928-5539
[email protected]
Timothy R. Wassenaar
Principal Investigator
Aurora Cancer Care-Milwaukee West
Wauwatosa Wisconsin, 53226, United States More Info
Site Public Contact
Contact
414-302-2304
[email protected]
Adam P. Siegel
Principal Investigator
Aurora West Allis Medical Center
West Allis Wisconsin, 53227, United States More Info
Site Public Contact
Contact
414-302-2304
[email protected]
Adam P. Siegel
Principal Investigator

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:

Recruiting

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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