Bladder Cancer Clinical Trial

Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder for Bladder Cancer Treatment, MODERN Study

Summary

This phase II/III trial tests the role of DNA released from tumor cells into the blood in guiding the use of immunotherapy (nivolumab alone or with relatlimab) after surgical removal of the bladder for bladder cancer treatment. DNA is material found inside all of our cells that acts as a blueprint for how cells function. Tumor cells often have abnormal DNA that looks different than DNA in normal cells. A new test called Signatera has been developed that can detect bladder cancer DNA in the blood which might indicate the presence of bladder tumor cells somewhere in the body. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Relatlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine if the Signatera test can better identify which patients need an additional treatment with immunotherapy to help prevent bladder cancer from coming back after surgery.

View Full Description

Full Description

PRIMARY OBJECTIVES:

I. To compare the ctDNA clearance proportion (i.e., ctDNA positive [+] --> ctDNA negative [-]) at 12 weeks in patients enrolled in Cohort A treated with adjuvant nivolumab versus nivolumab + relatlimab (phase 2 portion).

II. To compare overall survival in patients enrolled in Cohort A treated with adjuvant nivolumab versus nivolumab + relatlimab (phase 3 portion).

III. To compare disease-free survival in patients enrolled in Cohort B randomized to immediate treatment with nivolumab to those randomized to surveillance with subsequent treatment with nivolumab only upon converting to ctDNA(+)

SECONDARY OBJECTIVES:

I. To compare disease-free survival in patients enrolled in Cohort A treated with adjuvant nivolumab versus nivolumab + relatlimab.

II. To define the association between ctDNA clearance and disease-free survival and overall survival for Cohort A patients.

III. To compare overall survival in patients enrolled in Cohort B randomized to immediate treatment with nivolumab to those randomized to surveillance with subsequent treatment with nivolumab only upon converting to ctDNA(+).

IV. To determine the lead time from a ctDNA(+) assay to radiographic recurrence in patients initially ctDNA(-) post-definitive surgery enrolled in Cohort B.

V. To estimate the proportion of Cohort B patients on Arm 4 who become ctDNA(+) and receive nivolumab.

VI. To compare the cumulative incidence of Cohort B patients who become ctDNA(+) between Arms 3 and 4.

VII. To determine the safety of adjuvant nivolumab plus relatlimab.

EXPLORATORY OBJECTIVES:

I. To explore the kinetics of quantitative ctDNA levels (mean number of tumor molecules observed per mL of plasma or MTM/ml) over time and the association between ctDNA kinetics and time-to-event outcomes.

II. To estimate the costs and value of care in patients with a ctDNA(+) assay post-cystectomy treated with adjuvant nivolumab versus nivolumab + relatlimab.

III. To estimate the costs and value of care in patients with a ctDNA(-) assay post-cystectomy treated with adjuvant nivolumab versus surveillance with subsequent treatment with nivolumab at the time of conversion to ctDNA(+).

QUALITY OF LIFE OBJECTIVES:

I. Within each cohort, to compare quality-adjusted survival among randomized arms using European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L).

II. Within Cohort B, to compare overall quality of life (QOL) as measured by the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) between baseline and 42 months (calculated as the area under the curve) among randomized arms.

III. Within each cohort, to compare overall QOL as measured by the EORTC QLQ-C30 at each time point among randomized arms.

IV. Within each cohort, to compare bladder cancer-specific QOL as measured by the EORTC Bladder Cancer Muscle-Invasive 30 Questionnaire (QLQ-BLM30) at each time point among randomized arms.

V. Within each cohort, to compare patient-reported fatigue as measured by Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue at each time point among randomized arms.

VI. Within each cohort, to compare patient-reported fear of cancer recurrence as measured by the Fear of Cancer Recurrence Inventory (FCRI)-Short Form at each time point among randomized arms.

OUTLINE: Patients are assigned to 1 of 2 cohorts based on ctDNA results.

COHORT A: Patients who are ctDNA(+) are randomized to 1 of 2 arms:

ARM I: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) scans throughout the trial.

ARM II: Patients receive nivolumab IV over 30 minutes and relatlimab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo CT or MRI scans throughout the trial.

COHORT B: Patients who are ctDNA(-) are randomized to 1 of 2 arms:

ARM III: Patients receive nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo CT or MRI scans throughout the trial.

ARM IV: Patients undergo ctDNA surveillance consisting of collection of tissue and blood during screening and collection of blood only on study and during follow up. Patients who convert to ctDNA(+) during surveillance then receive nivolumab IV over 30 minutes and relatlimab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI scans throughout the trial.

After completion of study treatment, patients are followed up at weeks 60, 72, 84, 96, 120, 144, 196, and 248.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

PRE-REGISTRATION: Histologically confirmed muscle-invasive urothelial carcinoma of the bladder. Variant histology, including neuroendocrine differentiation, is allowed if urothelial cancer is predominant histology (any amount of squamous differentiation is allowed provided the tumor is not a pure squamous cell cancer)
PRE-REGISTRATION: Patient must have had radical cystectomy and lymph node dissection >= 3 weeks, but =< 12 weeks prior to pre-registration. Patients who have had a partial cystectomy as definitive therapy are not eligible
PRE-REGISTRATION: No gross cancer at the surgical margins. Microscopic invasive urothelial carcinoma at the surgical margins (i.e., "positive margins") are allowed. Carcinoma in situ (CIS) at margins is considered negative margins
PRE-REGISTRATION: No evidence of residual cancer or metastasis after cystectomy (imaging is not required prior to pre-registration but is required prior to registration)

PRE-REGISTRATION: Have undergone a radical cystectomy with pathological evidence of urothelial carcinoma of the bladder at high risk of recurrence as described in one of the two scenarios below (i or ii). The 7th edition of American Joint Committee on Cancer (AJCC) staging will be utilized.:

(i) Patients who have not received neoadjuvant cisplatin-based chemotherapy: pT3-pT4* or pT0/x-pT4/N+ on cystectomy and are not eligible for adjuvant cisplatin chemotherapy

(i) Patients ineligible for cisplatin due to at least one of the following criteria and reason for ineligibility should be documented:

(i) Creatinine Clearance (using Cockcroft-Gault): < 60 mL/min
(i) Common Terminology Criteria for Adverse Events (CTCAE) version 5, grade >= 2 audiometric hearing loss
(i) CTCAE version 5, grade >= 2 or above peripheral neuropathy
New York Heart Association Class III heart failure
(i) Eastern Cooperative Oncology Group (ECOG) performance status = 2

(i) Patients who are eligible for cisplatin may be candidates if they refuse available adjuvant chemotherapy, despite being informed by the investigator about the treatment options. The patient's refusal must be documented.

(i) Patients with pT2N0 urothelial cancer on cystectomy (without prior neoadjuvant chemotherapy) with ctDNA(+) Signatera results based on an assay performed post-cystectomy as part of routine care outside of the study may proceed with pre-registration but require confirmation of ctDNA(+) Signatera testing on repeat "central testing" in the context of A032103 testing. Patients with pT2N0 with central testing not confirming ctDNA(+) will not be eligible for A032103 (Note: this is distinct from patients with ypT2N0 who are eligible based on ii).
(ii) Patients who received cisplatin-based neoadjuvant chemotherapy: ypT2-ypT4 or ypT0/x-pT4/N+ on cystectomy
PRE-REGISTRATION: Available tumor tissue for central Signatera testing to be submitted after pre-registration. Central testing is defined as testing performed as part of the A032103 study prior to registration and is provided by the study and not routine standard commercial testing. Patients who have already had Signatera testing performed as part of routine care will require repeat central testing as part of the A032103 study to be eligible for registration/randomization. Tumor tissue from the cystectomy is preferred over tissue from prior transurethral resection
PRE-REGISTRATION: Age >= 18 years
PRE-REGISTRATION: ECOG Performance Status 0-2
PRE-REGISTRATION: Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects
PRE-REGISTRATION: No postoperative/adjuvant systemic therapy after cystectomy
PRE-REGISTRATION: No adjuvant radiation after cystectomy
PRE-REGISTRATION: No treatment with any other type of investigational agent =< 4 weeks before pre-registration
PRE-REGISTRATION: Not have ever received prior treatment with PD-1/PD-L1 blockade.
PRE-REGISTRATION: Not have ever received prior treatment with LAG-3 blockade.
PRE-REGISTRATION: 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
PRE-REGISTRATION: Absolute Neutrophil Count (ANC) >= 1,200/mm^3
PRE-REGISTRATION: Platelet count >= 100,000/mm^3
PRE-REGISTRATION: Hemoglobin >= 8 g/dL
PRE-REGISTRATION: Creatinine =< 1.5 x upper limit of normal (ULN) or calculated (calc.) creatinine clearance > 30 mL/min (using either Cockcroft-Gault formula or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
PRE-REGISTRATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x ULN
PRE-REGISTRATION: Total bilirubin =< 1.5 x upper limit of normal (ULN) (except in patients with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
PRE-REGISTRATION: For women of childbearing potential only: A negative urine or serum pregnancy test done =< 14 days prior to pre-registration is required
PRE-REGISTRATION: Not currently requiring hemodialysis
PRE-REGISTRATION: No current or prior history of myocarditis
PRE-REGISTRATION: No active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens- Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease.
PRE-REGISTRATION: Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible.
PRE-REGISTRATION: Patients with rheumatoid arthritis and other arthropathies, Sjögren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible.
PRE-REGISTRATION: No current pneumonitis or prior history of non-infectious pneumonitis that required steroids within the previous 5 years.
PRE-REGISTRATION: No known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected).
PRE-REGISTRATION: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
PRE-REGISTRATION: Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible.
PRE-REGISTRATION: No concurrent antineoplastic therapy.
PRE-REGISTRATION: No current immunosuppressive agents (with the exception of corticosteroids as described below).
PRE-REGISTRATION: No condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of pre-registration (with the exception of steroid pre-medications for contrast allergies). Inhaled or topical steroids and adrenal replacement doses < 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
REGISTRATION: Patient must have had radical cystectomy and lymph node dissection =< 18 weeks prior to registration.

REGISTRATION: Must have evaluable ctDNA Signatera assay result (i.e., ctDNA[+]or ctDNA[-]) based on test performed as part of central testing after pre-registration to A032103. Central testing is defined as testing performed as part of the A032103. Local/commercial testing results may not be used for registration to A032103

Cisplatin-ineligible (or cisplatin-declining) patients with a pT2N0 urothelial cancer on cystectomy who were pre-registered based on routine standard care ctDNA(+) Signatera testing must have confirmed ctDNA(+) Signatera testing on central testing. If central Signatera testing yields a ctDNA(-) result, these patients are ineligible. NOTE: This is a distinct consideration from patients with ypT2-4 and/or ypN+ urothelial cancer (i.e., patients who had received neoadjuvant cisplatin-based chemotherapy) who are eligible with either ctDNA(+) or ctDNA(-) central Signatera testing
REGISTRATION: All patients must have confirmed disease-free status defined as no measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or definitive non-measurable radiographic metastatic disease, within 60 days prior to registration. Patients with equivocal nodes less than 15 mm in short axis, or < 10 mm in long axis for non-lymph node lesions, not considered by the investigator to represent malignant disease will be eligible. Attempts should be made to resolve the etiology of equivocal lesions with complementary imaging (e.g., PET scan) or biopsy.
REGISTRATION: No major surgery =< 3 weeks before registration.
REGISTRATION: No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette- Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist [registered trademark]) are live attenuated vaccines and are not allowed. Coronavirus disease 2019 (COVID-19) vaccines are not live vaccines and are allowed

COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+):

Patient must have converted to ctDNA(+) during serial monitoring performed centrally in the setting of the A032103 study

COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+):

No evidence of metastatic disease on the most recent scheduled imaging assessment as outlined in the study calendar (no repeat imaging is necessary specifically at the time of the conversion from ctDNA[-] to ctDNA[+]).

COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+):

No change in clinical condition and/or laboratory tests that would impact the safety of nivolumab in the opinion of the treating investigator

COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+):

=< 6 weeks from reporting of ctDNA(+) result by Natera.

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

1190

Study ID:

NCT05987241

Recruitment Status:

Recruiting

Sponsor:

National Cancer Institute (NCI)

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There are 105 Locations for this study

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UC San Diego Moores Cancer Center
La Jolla California, 92093, United States More Info
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858-822-5354
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Tyler Stewart
Principal Investigator
Helen F Graham Cancer Center
Newark Delaware, 19713, United States More Info
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302-623-4450
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Gregory A. Masters
Principal Investigator
Medical Oncology Hematology Consultants PA
Newark Delaware, 19713, United States More Info
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302-623-4450
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Gregory A. Masters
Principal Investigator
Illinois CancerCare-Bloomington
Bloomington Illinois, 61704, United States More Info
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309-243-3605
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Bryan A. Faller
Principal Investigator
Illinois CancerCare-Canton
Canton Illinois, 61520, United States More Info
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309-243-3605
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Bryan A. Faller
Principal Investigator
Illinois CancerCare-Carthage
Carthage Illinois, 62321, United States More Info
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309-243-3605
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Bryan A. Faller
Principal Investigator
Northwestern University
Chicago Illinois, 60611, United States More Info
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312-695-1301
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Sarah Fenton
Principal Investigator
University of Illinois
Chicago Illinois, 60612, United States More Info
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312-355-3046
Karine Tawagi
Principal Investigator
University of Chicago Comprehensive Cancer Center
Chicago Illinois, 60637, United States More Info
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773-702-8222
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Randy F. Sweis
Principal Investigator
Cancer Care Specialists of Illinois - Decatur
Decatur Illinois, 62526, United States More Info
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217-876-4762
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Bryan A. Faller
Principal Investigator
Decatur Memorial Hospital
Decatur Illinois, 62526, United States More Info
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217-876-4762
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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
Crossroads Cancer Center
Effingham Illinois, 62401, United States More Info
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217-876-4762
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Bryan A. Faller
Principal Investigator
Illinois CancerCare-Eureka
Eureka Illinois, 61530, United States More Info
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309-243-3605
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Bryan A. Faller
Principal Investigator
Illinois CancerCare-Galesburg
Galesburg Illinois, 61401, United States More Info
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309-243-3605
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Bryan A. Faller
Principal Investigator
Illinois CancerCare-Kewanee Clinic
Kewanee Illinois, 61443, United States More Info
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309-243-3605
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Bryan A. Faller
Principal Investigator
Illinois CancerCare-Macomb
Macomb Illinois, 61455, United States More Info
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309-243-3605
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Bryan A. Faller
Principal Investigator
UC Comprehensive Cancer Center at Silver Cross
New Lenox Illinois, 60451, United States More Info
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773-702-8222
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Randy F. Sweis
Principal Investigator
Northwestern Medicine Orland Park
Orland Park Illinois, 60462, United States More Info
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[email protected]
Sarah Fenton
Principal Investigator
University of Chicago Medicine-Orland Park
Orland Park Illinois, 60462, United States More Info
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773-702-8222
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Randy F. Sweis
Principal Investigator
Illinois CancerCare-Ottawa Clinic
Ottawa Illinois, 61350, United States More Info
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309-243-3605
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Bryan A. Faller
Principal Investigator
Illinois CancerCare-Pekin
Pekin Illinois, 61554, United States More Info
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309-243-3605
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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
Memorial Hospital East
Shiloh Illinois, 62269, United States More Info
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314-747-9912
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Melissa A. Reimers
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
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Bryan A. Faller
Principal Investigator
Illinois CancerCare - Washington
Washington Illinois, 61571, United States More Info
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309-243-3605
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Bryan A. Faller
Principal Investigator
Mary Greeley Medical Center
Ames Iowa, 50010, United States More Info
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515-956-4132
Joseph J. Merchant
Principal Investigator
McFarland Clinic - Ames
Ames Iowa, 50010, United States More Info
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515-239-4734
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Joseph J. Merchant
Principal Investigator
Mission Cancer and Blood - Ankeny
Ankeny Iowa, 50023, United States More Info
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515-282-2921
Joshua Lukenbill
Principal Investigator
McFarland Clinic - Boone
Boone Iowa, 50036, United States More Info
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515-956-4132
Joseph J. Merchant
Principal Investigator
Iowa Methodist Medical Center
Des Moines Iowa, 50309, United States More Info
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515-241-6727
Joshua Lukenbill
Principal Investigator
Medical Oncology and Hematology Associates-Des Moines
Des Moines Iowa, 50309, United States More Info
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515-241-3305
Joshua Lukenbill
Principal Investigator
McFarland Clinic - Trinity Cancer Center
Fort Dodge Iowa, 50501, United States More Info
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515-956-4132
Joseph J. Merchant
Principal Investigator
McFarland Clinic - Jefferson
Jefferson Iowa, 50129, United States More Info
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515-956-4132
Joseph J. Merchant
Principal Investigator
McFarland Clinic - Marshalltown
Marshalltown Iowa, 50158, United States More Info
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515-956-4132
Joseph J. Merchant
Principal Investigator
Ochsner Medical Center Jefferson
New Orleans Louisiana, 70121, United States More Info
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504-842-8084
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Brian T. Halbert
Principal Investigator
Beverly Hospital
Beverly Massachusetts, 01915, United States More Info
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978-922-3000
Brendan Connell
Principal Investigator
Lahey Hospital and Medical Center
Burlington Massachusetts, 01805, United States More Info
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781-744-3421
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Brendan Connell
Principal Investigator
Addison Gilbert Hospital
Gloucester Massachusetts, 01930, United States More Info
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978-283-4000
Brendan Connell
Principal Investigator
Lahey Medical Center-Peabody
Peabody Massachusetts, 01960, United States More Info
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781-744-3421
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Brendan Connell
Principal Investigator
Winchester Hospital
Winchester Massachusetts, 01890, United States More Info
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888-823-5923
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Brendan Connell
Principal Investigator
Saint Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States More Info
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734-712-7251
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Elie G. Dib
Principal Investigator
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton Michigan, 48114, United States More Info
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734-712-7251
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Elie G. Dib
Principal Investigator
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton Michigan, 48188, United States More Info
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734-712-7251
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Elie G. Dib
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
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Elie G. Dib
Principal Investigator
Genesee Cancer and Blood Disease Treatment Center
Flint Michigan, 48503, United States More Info
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810-762-8038
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Elie G. Dib
Principal Investigator
Genesee Hematology Oncology PC
Flint Michigan, 48503, United States More Info
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810-762-8038
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Elie G. Dib
Principal Investigator
Genesys Hurley Cancer Institute
Flint Michigan, 48503, United States More Info
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810-762-8038
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Elie G. Dib
Principal Investigator
Hurley Medical Center
Flint Michigan, 48503, United States More Info
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810-762-8038
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Elie G. Dib
Principal Investigator
University of Michigan Health - Sparrow Lansing
Lansing Michigan, 48912, United States More Info
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517-364-3712
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Elie G. Dib
Principal Investigator
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia Michigan, 48154, United States More Info
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734-712-7251
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Elie G. Dib
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
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Elie G. Dib
Principal Investigator
Sanford Joe Lueken Cancer Center
Bemidji Minnesota, 56601, United States More Info
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218-333-5000
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Daniel Almquist
Principal Investigator
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States More Info
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601-815-6700
John C. Henegan
Principal Investigator
Saint Francis Medical Center
Cape Girardeau Missouri, 63703, United States More Info
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573-334-2230
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Bryan A. Faller
Principal Investigator
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia Missouri, 65212, United States More Info
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573-882-7440
Kushal Naha
Principal Investigator
Siteman Cancer Center at West County Hospital
Creve Coeur Missouri, 63141, United States More Info
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800-600-3606
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Melissa A. Reimers
Principal Investigator
Parkland Health Center - Farmington
Farmington Missouri, 63640, United States More Info
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314-996-5569
Bryan A. Faller
Principal Investigator
Washington University School of Medicine
Saint Louis Missouri, 63110, United States More Info
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800-600-3606
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Melissa A. Reimers
Principal Investigator
Siteman Cancer Center-South County
Saint Louis Missouri, 63129, United States More Info
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800-600-3606
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Melissa A. Reimers
Principal Investigator
Missouri Baptist Medical Center
Saint Louis Missouri, 63131, United States More Info
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314-996-5569
Bryan A. Faller
Principal Investigator
Siteman Cancer Center at Christian Hospital
Saint Louis Missouri, 63136, United States More Info
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800-600-3606
[email protected]
Melissa A. Reimers
Principal Investigator
Mercy Hospital Saint Louis
Saint Louis Missouri, 63141, United States More Info
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314-251-7066
Jay W. Carlson
Principal Investigator
Siteman Cancer Center at Saint Peters Hospital
Saint Peters Missouri, 63376, United States More Info
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800-600-3606
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Melissa A. Reimers
Principal Investigator
Sainte Genevieve County Memorial Hospital
Sainte Genevieve Missouri, 63670, United States More Info
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314-996-5569
Bryan A. Faller
Principal Investigator
Missouri Baptist Sullivan Hospital
Sullivan Missouri, 63080, United States More Info
Site Public Contact
Contact
314-996-5569
Bryan A. Faller
Principal Investigator
BJC Outpatient Center at Sunset Hills
Sunset Hills Missouri, 63127, United States More Info
Site Public Contact
Contact
314-996-5569
Bryan A. Faller
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
David H. Aggen
Principal Investigator
Monmouth Medical Center Southern Campus
Lakewood New Jersey, 08701, United States More Info
Site Public Contact
Contact
732-923-6564
[email protected]
Biren Saraiya
Principal Investigator
Monmouth Medical Center
Long Branch New Jersey, 07740, United States More Info
Site Public Contact
Contact
732-923-6564
[email protected]
Biren Saraiya
Principal Investigator
Memorial Sloan Kettering Monmouth
Middletown New Jersey, 07748, United States More Info
Site Public Contact
Contact
212-639-7592
David H. Aggen
Principal Investigator
Memorial Sloan Kettering Bergen
Montvale New Jersey, 07645, United States More Info
Site Public Contact
Contact
212-639-7592
David H. Aggen
Principal Investigator
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08903, United States More Info
Site Public Contact
Contact
732-235-7356
Biren Saraiya
Principal Investigator
Community Medical Center
Toms River New Jersey, 08755, United States More Info
Site Public Contact
Contact
732-557-8294
[email protected]
Biren Saraiya
Principal Investigator
Memorial Sloan Kettering Commack
Commack New York, 11725, United States More Info
Site Public Contact
Contact
212-639-7592
David H. Aggen
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
David H. Aggen
Principal Investigator
Mount Sinai Chelsea
New York New York, 10011, United States More Info
Site Public Contact
Contact
212-824-7309
[email protected]
Matthew D. Galsky
Principal Investigator
Mount Sinai Hospital
New York New York, 10029, United States More Info
Site Public Contact
Contact
212-824-7309
[email protected]
Matthew D. Galsky
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Site Public Contact
Contact
212-639-7592
David H. Aggen
Principal Investigator
Memorial Sloan Kettering Nassau
Uniondale New York, 11553, United States More Info
Site Public Contact
Contact
212-639-7592
David H. Aggen
Principal Investigator
UNC Lineberger Comprehensive Cancer Center
Chapel Hill North Carolina, 27599, United States More Info
Site Public Contact
Contact
877-668-0683
[email protected]
Matthew I. Milowsky
Principal Investigator
Sanford Bismarck Medical Center
Bismarck North Dakota, 58501, United States More Info
Site Public Contact
Contact
701-323-5760
[email protected]
Daniel Almquist
Principal Investigator
Sanford Broadway Medical Center
Fargo North Dakota, 58122, United States More Info
Site Public Contact
Contact
701-323-5760
[email protected]
Daniel Almquist
Principal Investigator
Sanford Roger Maris Cancer Center
Fargo North Dakota, 58122, United States More Info
Site Public Contact
Contact
701-234-6161
[email protected]
Daniel Almquist
Principal Investigator
Cancer Centers of Southwest Oklahoma Research
Lawton Oklahoma, 73505, United States More Info
Site Public Contact
Contact
877-231-4440
Adanma Anji Ayanambakkam Attanathi
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
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa Oklahoma, 74146, United States More Info
Site Public Contact
Contact
918-505-3200
Adanma Anji Ayanambakkam Attanathi
Principal Investigator
Providence Willamette Falls Medical Center
Oregon City Oregon, 97045, United States More Info
Site Public Contact
Contact
503-215-2614
[email protected]
Alison K. Conlin
Principal Investigator
Providence Portland Medical Center
Portland Oregon, 97213, United States More Info
Site Public Contact
Contact
503-215-2614
[email protected]
Alison K. Conlin
Principal Investigator
Providence Saint Vincent Medical Center
Portland Oregon, 97225, United States More Info
Site Public Contact
Contact
503-215-2614
[email protected]
Alison K. Conlin
Principal Investigator
Lehigh Valley Hospital-Cedar Crest
Allentown Pennsylvania, 18103, United States More Info
Site Public Contact
Contact
610-402-9543
[email protected]
Elie G. Dib
Principal Investigator
Lehigh Valley Hospital - Muhlenberg
Bethlehem Pennsylvania, 18017, United States More Info
Site Public Contact
Contact
610-402-9543
[email protected]
Elie G. Dib
Principal Investigator
Pocono Medical Center
East Stroudsburg Pennsylvania, 18301, United States More Info
Site Public Contact
Contact
610-402-9543
[email protected]
Elie G. Dib
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
Prisma Health Cancer Institute - Easley
Easley South Carolina, 29640, United States More Info
Site Public Contact
Contact
864-522-2066
[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 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]
Daniel Almquist
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]
Daniel Almquist
Principal Investigator
UT Southwestern Simmons Cancer Center - RedBird
Dallas Texas, 75237, United States More Info
Site Public Contact
Contact
214-648-7097
[email protected]
Tian Zhang
Principal Investigator
UT Southwestern/Simmons Cancer Center-Dallas
Dallas Texas, 75390, United States More Info
Site Public Contact
Contact
214-648-7097
[email protected]
Tian Zhang
Principal Investigator
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth Texas, 76104, United States More Info
Site Public Contact
Contact
214-648-7097
[email protected]
Tian Zhang
Principal Investigator
UT Southwestern Clinical Center at Richardson/Plano
Richardson Texas, 75080, United States More Info
Site Public Contact
Contact
972-669-7044
[email protected]
Tian Zhang
Principal Investigator
University of Wisconsin Carbone Cancer Center
Madison Wisconsin, 53792, United States More Info
Site Public Contact
Contact
800-622-8922
[email protected]
Christos Kyriakopoulos
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
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

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

1190

Study ID:

NCT05987241

Recruitment Status:

Recruiting

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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