Muscle Invasive Bladder Urothelial CarcinomaPhase 2/3NCT05987241
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
A Phase 2/3 study testing Biospecimen Collection, cfDNA or ctDNA Measurement and Computed Tomography in people with Muscle Invasive Bladder Urothelial Carcinoma and Muscle Invasive Renal Pelvis Urothelial Carcinoma, run by National Cancer Institute (NCI) at 505 sites in 2 countries.
Trial summary
This phase II/III trial examines whether patients who have undergone surgical removal of bladder, kidney, ureter or urethra, but require an additional treatment called immunotherapy to help prevent their urinary tract (urothelial) cancer from coming back, can be identified by a blood test. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma, Muscle Invasive Ureter Urothelial Carcinoma
- What is being tested?
- Biospecimen Collection, cfDNA or ctDNA Measurement and Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 992 participants
- Where
- 505 sitesin 2 countries
- Study dates
- 2 Feb 2024to 2 Sep 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PRE-REGISTRATION (STEP 0): Histologically confirmed muscle-invasive urothelial carcinoma of the urethra, bladder, ureter or renal pelvis
- PRE-REGISTRATION (STEP 0): Variant histology, including neuroendocrine differentiation, sarcomatoid, micropapillary, glandular, trophoblastic, Mullerian, 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 (STEP 0): Radical surgery (cystectomy with lymph node dissection or nephroureterectomy or ureterectomy) must be ≥ 3 weeks and ≤ 12 weeks (central Signatera pathway) or ≤ 16 weeks (commercial Signatera pathwary) prior to pre-registration. Patients who have had a partial cystectomy as definitive therapy are not eligible
- PRE-REGISTRATION (STEP 0): Patients who have had a partial cystectomy as definitive therapy are not eligible
- PRE-REGISTRATION (STEP 0): 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 (STEP 0): No evidence of residual cancer or metastasis after radical cystectomy or nephroureterectomy or ureterectomy (imaging is not required prior to pre-registration but is required prior to registration)
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- PRE-REGISTRATION (STEP 0): Have undergone a radical cystectomy nephroureterectomy, or ureterectomy with pathological evidence of urothelial carcinoma 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 systemic therapy: pT4N0 or pTanyN+ on radical surgery pathology specimen (i.e., cystectomy, nephroureterectomy, or ureterectomy) 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 adjuvant cisplatin may be candidates if they refuse adjuvant cisplatin-based 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 radical surgery specimen (without prior neoadjuvant systemic therapy) with ctDNA(+) Signatera results are eligible only if the result was obtained via commercial testing (central testing is not permitted for this population) (Note: this is distinct from patients with ypT2N0 who are eligible based on ii).
- (ii) Patients who received neoadjuvant systemic therapy: ypT2-T4N0 or Nx or ypTanyN+ on radical surgery (i.e., cystectomy. , nephroureterectomy, or ureterectomy) pathology specimen. Neoadjuvant systemic therapy may have included cisplatin-based chemotherapy, cisplatin-based chemotherapy plus PD-1/PD-L1 blockade, or enfortumab vedotin plus PD-1/PD-L1 blockade
- PRE-REGISTRATION (STEP 0): Patients are required to meet criteria for one of two criteria:
- 1) Commercial Signatera pathway:
- Available commercial Signatera testing result (i.e., ctDNA+ or ctDNA-) from blood sample obtained ≥ 3 weeks and ≤ 16 weeks from time of radical surgery performed as part of standard care
- Sites are required to verify that the commercial Signatera report demonstrates a complete 16 target assay design and that the test was designed on exome. This verification is conducted at the site level during the eligibility review. OR
- Central Signatera pathway:
- Pre-registration samples are to be submitted after pre-registration, at ≥ 3 weeks but ≤ 12 weeks from the time of radical surgery
- Ineligible patients for the commercial pathway must use the central Signatera pathway and provide tumor tissue as part of the A032103 study
- For patients who have not had neoadjuvant chemotherapy, tumor tissue is preferred from the radical surgery specimen
- For patients who have had neoadjuvant therapy, tissue is preferred from the pre-chemotherapy specimen diagnosing muscle-invasive disease (e.g., transurethral resection of bladder tumor specimen)
- PRE-REGISTRATION (STEP 0): Age >= 18 years
- PRE-REGISTRATION (STEP 0): ECOG performance status 0-2
- PRE-REGISTRATION (STEP 0): Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects
- PRE-REGISTRATION (STEP 0): No postoperative adjuvant systemic therapy after radical surgery
- PRE-REGISTRATION (STEP 0): No adjuvant radiation after radical surgery
- PRE-REGISTRATION (STEP 0): No treatment with any other type of investigational agent =< 4 weeks before pre-registration
- PRE-REGISTRATION (STEP 0): No previous treatment with LAG-3 blockade therapy
- PRE-REGISTRATION (STEP 0): 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 (STEP 0): Absolute neutrophil count (ANC) >= 1,200/mm^3
- PRE-REGISTRATION (STEP 0): Platelet count >= 100,000/mm^3
- PRE-REGISTRATION (STEP 0): Hemoglobin >= 8 g/dL
- PRE-REGISTRATION (STEP 0): 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 (STEP 0): Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x ULN
- PRE-REGISTRATION (STEP 0): 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 (STEP 0): For women of childbearing potential only: A negative urine or serum pregnancy test done =< 14 days prior to pre-registration is required
- PRE-REGISTRATION (STEP 0): Not currently requiring hemodialysis
- PRE-REGISTRATION (STEP 0): No current or prior history of myocarditis
- PRE-REGISTRATION (STEP 0): No history of a grade ≥ 3 immune related adverse event with prior PD-1/PD-L1 blockade in the neoadjuvant setting
- PRE-REGISTRATION (STEP 0): 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 (STEP 0): Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible.
- PRE-REGISTRATION (STEP 0): 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 (STEP 0): No current pneumonitis or prior history of non-infectious pneumonitis that required steroids within the previous 5 years.
- PRE-REGISTRATION (STEP 0): 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 (STEP 0): 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 (STEP 0): Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible.
- PRE-REGISTRATION (STEP 0): No concurrent antineoplastic therapy including anti-hormonal treatments used for cancer therapy (e.g., leuprolide, antiandrogens)
- PRE-REGISTRATION (STEP 0): No current immunosuppressive agents (except for corticosteroids as described below).
- PRE-REGISTRATION (STEP 0): 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 (STEP 1): Patient must have had radical cystectomy and lymph node dissection or nephroureterectomy or ureterectomy =< 18 weeks prior to registration.
- REGISTRATION (STEP 1): Must have evaluable ctDNA Signatera assay result (i.e., ctDNA+ or ctDNA-) based on either:
- Commercial Signatera result OR
- Central Signatera testing result (i.e. testing that was performed as part of A032103.)
- REGISTRATION (STEP 1): 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 lymph 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 (STEP 1): No major surgery =< 3 weeks before registration.
- REGISTRATION (STEP 1): 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
- REGISTRATION (STEP 1): No change since Step 0 pre-registration in clinical condition and/or laboratory tests that would impact the safety of nivolumab +/- relatlimab administration in the opinion of the treating investigator
- REGISTRATION (STEP 1): No evidence of high grade urothelial cancer in the bladder for patients with primary urothelial cancers of the upper urinary tract
- RE-REGISTRATION (STEP 2) 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 as part of A032103
- RE-REGISTRATION (STEP 2) 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[+]).
- RE-REGISTRATION (STEP 2) COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+):
- In the opinion of the treating investigator, patient clinical condition and laboratory tests would not impact the safety of nivolumab administration in the opinion of the treating investigator
Who cannot join
None listed.
Trial locations and contacts
505 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
310 sites in 2 countries
United States300 sites, 266 recruiting
- Recruiting
Atrium Health Stanly/LCI-Albemarle
Albemarle, North Carolina, 28002
Site Public Contact, 800-804-9376
Landon C. Brown
- Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu
Amy C. Tarnower
- Recruiting
Presbyterian Kaseman Hospital
Albuquerque, New Mexico, 87110
Site Public Contact, 505-559-6113, WBurman@phs.org
Amy C. Tarnower
- Recruiting
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Elie G. Dib
- Recruiting
UPMC Altoona
Altoona, Pennsylvania, 16601
Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org
Leonard J. Appleman
- Recruiting
Mary Greeley Medical Center
Ames, Iowa, 50010
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
McFarland Clinic - Ames
Ames, Iowa, 50010
Site Public Contact, 515-239-4734, ksoder@mcfarlandclinic.com
Joseph J. Merchant
- Recruiting
Community Hospital of Anaconda
Anaconda, Montana, 59711
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Kaiser Permanente-Anaheim
Anaheim, California, 92806
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Helen H. Moon
- Recruiting
AnMed Health Cancer Center
Anderson, South Carolina, 29621
Site Public Contact, 864-512-4651, rhonda.ballew@anmedhealth.org
Jay B. Nayak
- Recruiting
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Site Public Contact, 800-865-1125, CancerAnswerLine@med.umich.edu
Irene Tsung
- Recruiting
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
Site Public Contact, 920-364-3604, ResearchDept@thedacare.org
Joyce Philip
- Active, not recruiting
OhioHealth O'Bleness Hospital
Athens, Ohio, 45701
- Recruiting
Grady Health System
Atlanta, Georgia, 30303
Site Public Contact, 404-778-1868
Jacqueline T. Brown
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Site Public Contact, 888-946-7447
Jacqueline T. Brown
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Site Public Contact, 404-778-1868
Jacqueline T. Brown
- Recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Site Public Contact, 404-851-7115
Jacqueline T. Brown
- Recruiting
Northside Hospital
Atlanta, Georgia, 30342
Site Public Contact, 404-303-3355, ClinicalTrials@northside.com
Louis C. Garrot
- Recruiting
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
Site Public Contact, 720-848-0650
Elizabeth R. Kessler
- Recruiting
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180
Site Public Contact, 305-674-2625, yenrique@msmc.com
Oleg Gligich
- Suspended
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180
- Recruiting
Hartford HealthCare - Avon
Avon, Connecticut, 06001
Site Public Contact, 860-972-4700
Michael Sun
- Recruiting
Kaiser Permanente-Baldwin Park
Baldwin Park, California, 91706
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Helen H. Moon
- Recruiting
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, 63011
Site Public Contact, 888-446-3729
Jay W. Carlson
- Recruiting
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
Site Public Contact, 800-888-8823
Heather D. Mannuel
- Recruiting
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Site Public Contact, 410-955-8804, jhcccro@jhmi.edu
Jean H. Hoffman-Censits
- Recruiting
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010
Site Public Contact, 847-842-4847
Adam P. Siegel
- Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Site Public Contact, 212-639-7592
David H. Aggen
- Recruiting
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, 70809
Site Public Contact, 225-215-1353, clinicalresearch@marybird.com
Scott E. Delacroix
- Recruiting
Bronson Battle Creek
Battle Creek, Michigan, 49017
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
McLaren Cancer Institute-Bay City
Bay City, Michigan, 48706
Site Public Contact, 313-576-9790, ctoadmin@karmanos.org
Yusra F. Shao
- Recruiting
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, 15009
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Leonard J. Appleman
- Recruiting
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123
Site Public Contact, 402-559-6941, unmcrsa@unmc.edu
Harshraj Leuva
- Recruiting
Kaiser Permanente-Bellflower
Bellflower, California, 90706
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Helen H. Moon
- Recruiting
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Site Public Contact, 218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602
Site Public Contact, 802-225-5400
Steven Ades
- Recruiting
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Elie G. Dib
- Suspended
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, 52722
- Recruiting
Beverly Hospital
Beverly, Massachusetts, 01915
Site Public Contact, 978-922-3000 ext. 2405
Brett Dumas
- Recruiting
Billings Clinic Cancer Center
Billings, Montana, 59101
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Recruiting
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
Elie G. Dib
- Suspended
McFarland Clinic - Boone
Boone, Iowa, 50036
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Site Public Contact, 617-667-9925
David Einstein
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Site Public Contact, 877-442-3324
Stephanie A. Berg
- Recruiting
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Lafayette Family Cancer Center-EMMC
Brewer, Maine, 04412
Site Public Contact, 800-987-3005
Sarah J. Sinclair
- Recruiting
Hartford HealthCare - Saint Vincent's Medical Center
Bridgeport, Connecticut, 06606
Site Public Contact, 860-972-4700
Michael Sun
- Recruiting
Dana-Farber Cancer Institute at Boston Medical Center - Brighton
Brighton, Massachusetts, 02135
Site Public Contact, 617-789-2903
Olga Kozyreva
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
University of Michigan - Brighton Center for Specialty Care
Brighton, Michigan, 48116
Site Public Contact, 800-865-1125
Irene Tsung
- Recruiting
Maimonides Medical Center
Brooklyn, New York, 11219
Site Public Contact, 718-765-2500
Abhigna Kodali
- Recruiting
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Clara Hwang
- Active, not recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
- Recruiting
Lahey Clinic
Burlington, Massachusetts, 01805
Site Public Contact, 781-744-3421, lhmc-cancer-clinical-trials@lahey.org
Brett Dumas
- Recruiting
University of Vermont Medical Center
Burlington, Vermont, 05401
Site Public Contact, 802-656-4101, rpo@uvm.edu
Steven Ades
- Recruiting
University of Vermont and State Agricultural College
Burlington, Vermont, 05405
Site Public Contact, 802-656-8990, rpo@uvm.edu
Steven Ades
- Recruiting
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
Elie G. Dib
- Recruiting
Illinois CancerCare-Canton
Canton, Illinois, 61520
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Site Public Contact, 573-334-2230, sfmc@sfmc.net
Bryan A. Faller
- Recruiting
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Suspended
Duke Cancer Center Cary
Cary, North Carolina, 27518
- Recruiting
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu
Matthew I. Milowsky
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu
Theodore S. Gourdin
- Recruiting
Vandalia Health/CAMC Institute for Academic Medicine
Charleston, West Virginia, 25304
Site Public Contact, 304-388-9944, CAMCClinicalTrials@vandaliahealth.org
Kok Hoe Chan
- Recruiting
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
Site Public Contact, 800-804-9376
Landon C. Brown
- Recruiting
Atrium Health Pineville/LCI-Pineville
Charlotte, North Carolina, 28210
Site Public Contact, 980-442-2000
Landon C. Brown
- Recruiting
Levine Cancer Institute-SouthPark
Charlotte, North Carolina, 28211
Site Public Contact, 980-442-2000
Landon C. Brown
- Recruiting
Atrium Health University City/LCI-University
Charlotte, North Carolina, 28262
Site Public Contact, 800-804-9376
Landon C. Brown
- Recruiting
Levine Cancer Institute-Ballantyne
Charlotte, North Carolina, 28277
Site Public Contact, 800-804-9376
Landon C. Brown
- Recruiting
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
Site Public Contact, 434-243-6303, uvacancertrials@hscmail.mcc.virginia.edu
Paul V. Viscuse
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Jefferson Cherry Hill Hospital
Cherry Hill, New Jersey, 08002
Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu
Patrick Mille
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Site Public Contact, 312-695-1301, cancer@northwestern.edu
David VanderWeele
- Recruiting
University of Illinois
Chicago, Illinois, 60612
Site Public Contact, 312-355-3046
Natalie Reizine
- Recruiting
Swedish Covenant Hospital
Chicago, Illinois, 60625
Site Public Contact, 773-878-8200
Nicklas R. Pfanzelter
- Recruiting
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Randy F. Sweis
- Recruiting
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
Site Public Contact, 773-296-5360
Adam P. Siegel
- Recruiting
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
Site Public Contact, 513-584-7698, cancer@uchealth.com
Robert A. Franklin
- Recruiting
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Melissa A. Reimers
- Recruiting
Wake Forest University at Clemmons
Clemmons, North Carolina, 27012
Site Public Contact, 888-716-9259
Michael McCormack
- Recruiting
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Clara Hwang
- Recruiting
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri, 65212
Site Public Contact, 573-882-7440
Mark R. Wakefield
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Site Public Contact, 800-293-5066, Jamesline@osumc.edu
Lingbin Meng
- Active, not recruiting
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214
- Active, not recruiting
Riverside Methodist Hospital
Columbus, Ohio, 43214
- Active, not recruiting
Grant Medical Center
Columbus, Ohio, 43215
- Active, not recruiting
Doctors Hospital
Columbus, Ohio, 43228
- Recruiting
Memorial Sloan Kettering Commack
Commack, New York, 11725
Site Public Contact, 212-639-7592
David H. Aggen
- Active, not recruiting
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, 03301
- Recruiting
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, 28025
Site Public Contact, 800-804-9376
Landon C. Brown
- Recruiting
Mercy Hospital
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146
Site Public Contact, 305-243-2647
Janaki N. Sharma
- Recruiting
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Melissa A. Reimers
- Recruiting
UChicago Medicine Northwest Indiana
Crown Point, Indiana, 46307
Site Public Contact, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Randy F. Sweis
- Recruiting
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014
Site Public Contact, 630-929-6129, advocateresearch@advocate.com
Adam P. Siegel
- Recruiting
Aurora Saint Luke's South Shore
Cudahy, Wisconsin, 53110
Site Public Contact, 414-302-2304, ncorp@aurora.org
Adam P. Siegel
- Recruiting
UPMC Western Maryland
Cumberland, Maryland, 21502
Site Public Contact, 240-964-1400
Leonard J. Appleman
- Recruiting
UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas, 75237
Site Public Contact, 214-648-7097, canceranswerline@utsouthwestern.edu
Tian Zhang
- Recruiting
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
Tian Zhang
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Priyank P. Patel
- Recruiting
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, 48126
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Clara Hwang
- Recruiting
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Decatur Memorial Hospital
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442
Site Public Contact, 305-243-2647
Janaki N. Sharma
- Recruiting
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
David VanderWeele
- Active, not recruiting
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015
- Active, not recruiting
Grady Memorial Hospital
Delaware, Ohio, 43015
- Recruiting
Kaiser Permanente-Franklin
Denver, Colorado, 80205
Site Public Contact, 303-817-9295, KPCOIHRClinicalResearch@kp.org
Matthew J. Eadens
- Recruiting
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, 06418
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Joseph W. Kim
- Recruiting
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Site Public Contact, 515-241-6727
Seema Harichand-Herdt
- Recruiting
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
Site Public Contact, 800-527-6266, ctoadmin@karmanos.org
Yusra F. Shao
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Clara Hwang
- Recruiting
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
Site Public Contact, 815-285-7800
Bryan A. Faller
- Recruiting
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
Site Public Contact, 630-275-1270, Barbara.barhamand@advocatehealth.com
Adam P. Siegel
- Recruiting
Kaiser Permanente Dublin
Dublin, California, 94568
Site Public Contact, 877-642-4691
Andrea L. Harzstark
- Active, not recruiting
Columbus Oncology and Hematology Associates
Dublin, Ohio, 43016
- Active, not recruiting
Dublin Methodist Hospital
Dublin, Ohio, 43016
- Recruiting
Northside Hospital - Duluth
Duluth, Georgia, 30096
Site Public Contact, 404-303-3355, Clinical.trials@northside.com
Louis C. Garrot
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Site Public Contact, 888-275-3853
Hannah D. McManus
- Recruiting
Duke Cancer Center Southpoint
Durham, North Carolina, 27713
Site Public Contact, NCTNStudyTeam@dm.duke.edu
Hannah D. McManus
- Recruiting
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Elie G. Dib
- Recruiting
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Michael Husak
- Recruiting
Fairview Southdale Hospital
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Minnesota Oncology - Edina
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Priyank P. Patel
- Recruiting
Crossroads Cancer Center
Effingham, Illinois, 62401
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Advocate Sherman Hospital
Elgin, Illinois, 60123
Site Public Contact, 847-429-2907
Adam P. Siegel
- Active, not recruiting
Elmhurst Memorial Hospital
Elmhurst, Illinois, 60126
- Recruiting
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505
Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu
Leonard J. Appleman
- Recruiting
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, 49829
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Anthony J. Jaslowski
- Recruiting
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201
Site Public Contact, 847-570-2109
Nicklas R. Pfanzelter
- Recruiting
Hartford Healthcare - Fairfield
Fairfield, Connecticut, 06824
Site Public Contact, 860-972-4700, CancerResearchSupport@hhchealth.org
Michael Sun
- Recruiting
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, 06824
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Joseph W. Kim
- Recruiting
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Site Public Contact, 701-234-6161, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
Site Public Contact, 313-576-9790, ctoadmin@karmanos.org
Yusra F. Shao
- Recruiting
Highlands Oncology Group - Fayetteville
Fayetteville, Arkansas, 72703
Site Public Contact, 479-872-8100, research@hogonc.com
Joseph T. Beck
- Recruiting
Cancer Hematology Centers - Flint
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Suspended
Genesee Hematology Oncology PC
Flint, Michigan, 48503
- Recruiting
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Recruiting
Hurley Medical Center
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Recruiting
The New York Hospital Medical Center of Queens
Flushing, New York, 11355
Site Public Contact, 888-823-5923, ctsucontact@westat.com
Leen Khoury
- Recruiting
Kaiser Permanente-Fontana
Fontana, California, 92335
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Helen H. Moon
- Recruiting
Levine Cancer Institute - Rutherford
Forest City, North Carolina, 28043
Site Public Contact, 800-804-9376
Landon C. Brown
- Recruiting
Poudre Valley Hospital
Fort Collins, Colorado, 80524
Site Public Contact, 970-297-6150
Elizabeth R. Kessler
- Recruiting
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, 80528
Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org
Elizabeth R. Kessler
- Recruiting
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas, 76104
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
Tian Zhang
- Recruiting
Dana-Farber Cancer Institute at Foxborough
Foxborough, Massachusetts, 02035
Site Public Contact, 877-338-7425
Daniel Roberts
- Recruiting
FMH James M Stockman Cancer Institute
Frederick, Maryland, 21702
Site Public Contact, 301-668-7043
Saro Sarkisian
- Recruiting
Kaiser Permanente-Fremont
Fremont, California, 94538
Site Public Contact, 877-642-4691, Kpoct@kp.org
Andrea L. Harzstark
- Recruiting
Kaiser Permanente Fresno Orchard Plaza
Fresno, California, 93720
Site Public Contact, 833-574-2273
Andrea L. Harzstark
- Recruiting
Kaiser Permanente-Fresno
Fresno, California, 93720
Site Public Contact, 877-642-4691, Kpoct@kp.org
Andrea L. Harzstark
- Recruiting
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341
Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org
Michael Humeniuk
- Recruiting
Malcom Randall Veterans Administration Medical Center
Gainesville, Florida, 32610
Site Public Contact, 352-273-8675, trials@cancer.ufl.edu
Jess DeLaune
- Recruiting
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610
Site Public Contact, 352-273-8010, cancer-center@ufl.edu
Daniel V. Araujo
- Recruiting
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Levine Cancer Institute-Gaston
Gastonia, North Carolina, 28054
Site Public Contact, 800-804-9376
Landon C. Brown
- Recruiting
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
David VanderWeele
- Active, not recruiting
The West Clinic - Wolf River
Germantown, Tennessee, 38138
- Suspended
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, 06033
- Recruiting
Glens Falls Hospital
Glens Falls, New York, 12801
Site Public Contact, 518-926-6700
Steven Ades
- Recruiting
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, 60026
Site Public Contact, 847-570-2109
Nicklas R. Pfanzelter
- Recruiting
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, 60026
Site Public Contact, 312-695-1102
David VanderWeele
- Recruiting
Addison Gilbert Hospital
Gloucester, Massachusetts, 01930
Site Public Contact, 978-283-4000 ext. 559
Brett Dumas
- Recruiting
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024
Site Public Contact, 414-302-2304, ncorp@aurora.org
Adam P. Siegel
- Recruiting
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Elie G. Dib
- Recruiting
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, 60030
Site Public Contact, 312-695-1102
David VanderWeele
- Recruiting
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
UCHealth Greeley Hospital
Greeley, Colorado, 80631
Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org
Elizabeth R. Kessler
- Recruiting
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Anthony J. Jaslowski
- Recruiting
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
Site Public Contact, 920-433-8889, wi_research_admin@hshs.org
Anthony J. Jaslowski
- Recruiting
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
Site Public Contact, 414-302-2304, ncorp@aurora.org
Adam P. Siegel
- Recruiting
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601
Site Public Contact, 724-838-1900
Leonard J. Appleman
- Recruiting
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, 06830
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Joseph W. Kim
- Recruiting
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Recruiting
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org
Michael Humeniuk
- Recruiting
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, 06437
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Joseph W. Kim
- Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Site Public Contact, 551-996-2897
Robert S. Alter
- Recruiting
Kaiser Permanente South Bay
Harbor City, California, 90710
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Helen H. Moon
- Recruiting
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, 17109
Site Public Contact, 717-724-6765, klitchfield@PINNACLEHEALTH.org
Leonard J. Appleman
- Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Site Public Contact, 212-639-7592
David H. Aggen
- Recruiting
Hartford Hospital
Hartford, Connecticut, 06102
Site Public Contact, 860-545-5363
Michael Sun
- Suspended
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105
- Recruiting
Ingalls Memorial Hospital
Harvey, Illinois, 60426
Site Public Contact, 708-915-4673, clinicaltrials@ingalls.org
James A. Wallace
- Recruiting
HaysMed
Hays, Kansas, 67601
Site Public Contact, 785-623-5774
Saqib Abbasi
- Recruiting
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429
Site Public Contact, 708-799-9995
Adam P. Siegel
- Recruiting
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, 60035
Site Public Contact, 847-570-2109
Nicklas R. Pfanzelter
- Recruiting
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, 80129
Site Public Contact, 720-848-0650
Elizabeth R. Kessler
- Recruiting
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
Site Public Contact, 954-265-1847, OHR@mhs.net
Matthew P. Salzberg
- Recruiting
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819
Site Public Contact, 808-432-5195, shelley.a.clark@kp.org
Andrea L. Harzstark
- Recruiting
Lyndon Baines Johnson General Hospital
Houston, Texas, 77026-1967
Site Public Contact, 713-566-5000
Debanjan Pain
- Recruiting
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
Site Public Contact, 713-798-1354, burton@bcm.edu
Aihua E. Yen
- Recruiting
Ben Taub General Hospital
Houston, Texas, 77030
Site Public Contact, 713-873-2000
Aihua E. Yen
- Recruiting
Michael E DeBakey VA Medical Center
Houston, Texas, 77030
Site Public Contact, 800-553-2278
Aihua E. Yen
- Recruiting
Levine Cancer Institute - Huntersville
Huntersville, North Carolina, 28078
Site Public Contact, 980-442-2000
Landon C. Brown
- Recruiting
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Site Public Contact, 317-278-5632, iutrials@iu.edu
Tareq Salous
- Recruiting
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Site Public Contact, 800-237-1225
Vitor Fiorin De Vasconcellos
- Recruiting
Kaiser Permanente-Irvine
Irvine, California, 92618
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Helen H. Moon
- Recruiting
Allegiance Health
Jackson, Michigan, 49201
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Clara Hwang
- Recruiting
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Site Public Contact, 601-815-6700
John C. Henegan
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Site Public Contact, 855-776-0015
Arnab Basu
- Suspended
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129
- Active, not recruiting
MU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri, 65109
- Recruiting
Jersey City Medical Center
Jersey City, New Jersey, 07302
Site Public Contact, 888-823-5923, ctsucontact@westat.com
Biren Saraiya
- Recruiting
Emory Johns Creek Hospital
Johns Creek, Georgia, 30097
Site Public Contact, 404-778-5714, m.lisa.hwang@emory.edu
Jacqueline T. Brown
- Recruiting
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Logan Health Medical Center
Kalispell, Montana, 59901
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Saqib Abbasi
- Recruiting
University Health Truman Medical Center
Kansas City, Missouri, 64108
Site Public Contact, 816-404-4375
Saqib Abbasi
- Recruiting
University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri, 64116
Site Public Contact, 913-588-3671
Saqib Abbasi
- Suspended
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, 64128
- Recruiting
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Saqib Abbasi
- Recruiting
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Site Public Contact, 858-822-5354, cancercto@ucsd.edu
Tyler Stewart
- Recruiting
Kaiser Permanente-Rock Creek
Lafayette, Colorado, 80026
Site Public Contact, 303-817-9295, KPCOIHRClinicalResearch@kp.org
Matthew J. Eadens
- Recruiting
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
Site Public Contact, cancertrials@northwestern.edu
David VanderWeele
- Recruiting
Monmouth Medical Center Southern Campus
Lakewood, New Jersey, 08701
Site Public Contact, 732-923-6564, mary.danish@rwjbh.org
Biren Saraiya
- Active, not recruiting
Lancaster General Ann B Barshinger Cancer Institute
Lancaster, Pennsylvania, 17601
- Recruiting
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, 48910
Site Public Contact, 313-576-9790, ctoadmin@karmanos.org
Yusra F. Shao
- Recruiting
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912
Site Public Contact, 517-364-3712, harsha.trivedi@umhsparrow.org
Elie G. Dib
- Suspended
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102
- Suspended
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89183
- Recruiting
Lawrence Memorial Hospital
Lawrence, Kansas, 66044
Site Public Contact, 785-505-2800, Stephanie.Norris@LMH.ORG
Saqib Abbasi
- Recruiting
Northside Hospital - Gwinnett
Lawrenceville, Georgia, 30046
Site Public Contact, 404-303-3355, Clinical.trials@northside.com
Louis C. Garrot
- Recruiting
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, 73505
Site Public Contact, 877-231-4440
Adanma Anji Ayanambakkam Attanathi
- Recruiting
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Saqib Abbasi
- Recruiting
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
Site Public Contact, 859-257-3379
Patrick J. Hensley
- Recruiting
AMG Libertyville - Oncology
Libertyville, Illinois, 60048
Site Public Contact, 630-929-6129, advocateresearch@advocatehealth.com
Adam P. Siegel
- Recruiting
Condell Memorial Hospital
Libertyville, Illinois, 60048
Site Public Contact, 630-929-6129, advocateresearch@advocatehealth.com
Adam P. Siegel
- Recruiting
Atrium Health Lincoln/LCI-Lincolnton
Lincolnton, North Carolina, 28092
Site Public Contact, 800-804-9376
Landon C. Brown
- Recruiting
Cooperman Barnabas Medical Center
Livingston, New Jersey, 07039
Site Public Contact, 973-322-5200
Biren Saraiya
- Recruiting
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Kaiser Permanente-Lone Tree
Lone Tree, Colorado, 80124
Site Public Contact, 303-817-9295, KPCOIHRClinicalResearch@kp.org
Matthew J. Eadens
- Recruiting
UCHealth Lone Tree Health Center
Lone Tree, Colorado, 80124
Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org
Elizabeth R. Kessler
- Recruiting
Monmouth Medical Center
Long Branch, New Jersey, 07740
Site Public Contact, 732-923-6564, mary.danish@rwjbh.org
Biren Saraiya
- Active, not recruiting
Keck Medicine of USC Koreatown
Los Angeles, California, 90020
- Recruiting
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Helen H. Moon
- Active, not recruiting
Los Angeles General Medical Center
Los Angeles, California, 90033
- Active, not recruiting
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
- Recruiting
Kaiser Permanente West Los Angeles
Los Angeles, California, 90034
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Helen H. Moon
- Recruiting
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
Site Public Contact, 888-798-0719
Alexandra Drakaki
- Recruiting
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202
Site Public Contact, 502-562-3429
Rohit Kumar
- Active, not recruiting
Baptist Health Louisville
Louisville, Kentucky, 40207
- Recruiting
UofL Health Medical Center Northeast
Louisville, Kentucky, 40245
Site Public Contact, 502-852-2755, ctoinfo@louisville.edu
Rohit Kumar
- Recruiting
Medical Center of the Rockies
Loveland, Colorado, 80538
Site Public Contact, 970-203-7083
Elizabeth R. Kessler
- Recruiting
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718
Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu
Anthony Serritella
- Recruiting
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu
Anthony Serritella
- Recruiting
Southern Ocean County Medical Center
Manahawkin, New Jersey, 08050
Site Public Contact, 609-978-3429
Evan C. Naylor
- Recruiting
Hartford HealthCare - Manchester
Manchester, Connecticut, 06042
Site Public Contact, 860-972-4700
Michael Sun
- Active, not recruiting
Solinsky Center for Cancer Care
Manchester, New Hampshire, 03103
- Active, not recruiting
OhioHealth Mansfield Hospital
Mansfield, Ohio, 44903
- Recruiting
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143
Site Public Contact, 414-302-2304, ncorp@aurora.org
Adam P. Siegel
- Active, not recruiting
OhioHealth Marion General Hospital
Marion, Ohio, 43302
- Recruiting
McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Michael Husak
- Recruiting
Levine Cancer Institute - Union West
Matthews, North Carolina, 28104
Site Public Contact, 980-442-0600
Landon C. Brown
- Recruiting
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Site Public Contact, 800-446-5532, Research@carle.com
Priyank P. Patel
- Recruiting
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania, 17050
Site Public Contact, 412-389-5208, haneydl@upmc.edu
Leonard J. Appleman
- Recruiting
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, 23116
Site Public Contact, 804-893-8978, anne_carmellat@bshsi.org
Joseph D. Pennington
- Recruiting
Midstate Medical Center
Meriden, Connecticut, 06451
Site Public Contact, 866-662-5678
Michael Sun
- Recruiting
Mary Bird Perkins Cancer Center - Metairie
Metairie, Louisiana, 70002
Site Public Contact, 504-584-6990
Scott E. Delacroix
- Recruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
Site Public Contact, 305-243-2647
Janaki N. Sharma
- Recruiting
Miami Cancer Institute
Miami, Florida, 33176
Site Public Contact, 786-596-2000
Rohan Garje
- Recruiting
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, 33176
Site Public Contact, 305-243-2647
Janaki N. Sharma
- Recruiting
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Site Public Contact, 305-674-2625, Yvonne.Enriquez@msmc.com
Oleg Gligich
- Recruiting
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Site Public Contact, 212-639-7592
David H. Aggen
- Recruiting
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, 23114
Site Public Contact, 804-893-8978, anne_carmellat@bshsi.org
Joseph D. Pennington
- Recruiting
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
Milford, Massachusetts, 01757
Site Public Contact, 877-332-4294
Daniel E. Fein
- Recruiting
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Site Public Contact, 414-302-2304, ncorp@aurora.org
Adam P. Siegel
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Site Public Contact, 414-805-3666
Kathryn A. Bylow
- Recruiting
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
Site Public Contact, 414-302-2304, ncorp@aurora.org
Adam P. Siegel
- Active, not recruiting
NYU Langone Hospital - Long Island
Mineola, New York, 11501
- Recruiting
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
Yan Ji
- Recruiting
Community Medical Center
Missoula, Montana, 59804
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Kaiser Permanente- Modesto MOB II
Modesto, California, 95356
Site Public Contact, 877-642-4691
Andrea L. Harzstark
- Recruiting
Kaiser Permanente-Modesto
Modesto, California, 95356
Site Public Contact, 877-642-4691, Kpoct@kp.org
Andrea L. Harzstark
- Recruiting
Atrium Health Union/LCI-Union
Monroe, North Carolina, 28112
Site Public Contact, 980-442-2000
Landon C. Brown
Canada10 sites, 10 recruiting
- Recruiting
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
Site Public Contact, 888-823-5923, ctsucontact@westat.com
Nimira S. Alimohamed
- Recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Site Public Contact, 780-432-8500
Scott A. North
- Recruiting
Waterloo Regional Health Network
Kitchener, Ontario, N2G 1G3
Site Public Contact, 519-749-4370, research@wrhn.ca
Anupam Batra
- Recruiting
London Regional Cancer Program
London, Ontario, N6A 4L6
Site Public Contact, 519-685-8600
Melissa Huynh
- Recruiting
Ottawa Hospital and Cancer Center-General Campus
Ottawa, Ontario, K1H 8L6
Site Public Contact, 613-761-4395
Ana-Alicia Beltran-Bless
- Recruiting
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Site Public Contact, 306-766-2213
Osama Souied
- Recruiting
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Site Public Contact, 306-655-2914
Sunil K. Yadav
- Recruiting
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Site Public Contact, 416-480-5000
Susanna Y. Cheng
- Recruiting
University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Site Public Contact, 416-946-4501, clinical.trials@uhn.on.ca
Srikala S. Sridhar
- Recruiting
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6
Site Public Contact, 888-939-3333
Bernie (Bernhard) J. Eigl
About this study
Official title: MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of ADjuvant ThErapy in URothelial CaNcer
This phase II/III trial examines whether patients who have undergone surgical removal of bladder, kidney, ureter or urethra, but require an additional treatment called immunotherapy to help prevent their urinary tract (urothelial) cancer from coming back, can be identified by a blood test. Many types of tumors tend to lose cells or release different types of cellular products including their DNA which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for disease progression or relapse. In this study, a blood test is used to measure ctDNA and see if there is still cancer somewhere in the body after surgery and if giving a treatment will help eliminate the cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and relatlimab, can help the body's immune system to attack the cancer, and can interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine if ctDNA measurement in blood can better identify patients that need additional treatment, if treatment with nivolumab prolongs patients' life and whether the additional immunotherapy treatment with relatlimab extends time without disease progression or prolongs life of urothelial cancer patients who have undergone surgical removal of their bladder, kidney, ureter or urethra.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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. VIII. To compare disease-free survival and overall survival in patients enrolled in Cohort A treated with adjuvant nivolumab versus nivolumab + relatlimab according to receipt of neoadjuvant immune checkpoint blockade-containing therapy versus no neoadjuvant immune checkpoint blockade-containing therapy.
IX. To compare disease-free survival and overall survival in patients enrolled in Cohort B treated with adjuvant nivolumab versus nivolumab + relatlimab according to receipt of neoadjuvant immune checkpoint blockade-containing therapy versus no neoadjuvant immune checkpoint blockade-containing therapy.
EXPLORATORY OBJECTIVES:
- 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-radical surgery treated with adjuvant nivolumab versus nivolumab + relatlimab.
III. To estimate the costs and value of care in patients with a ctDNA(-) assay post-radical surgery treated with adjuvant nivolumab versus surveillance with subsequent treatment with nivolumab at the time of conversion to ctDNA(+).
QUALITY OF LIFE OBJECTIVES:
- 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.
- 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.
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) and may undergo cystoscopy 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 and may undergo cystoscopy 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 and may undergo cystoscopy 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 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 and may undergo cystoscopy throughout the trial.
After completion of study treatment, patients are followed up at weeks 48, 60, 72, 84, 96, 120, 144, 196, and 248.
- Conditions
- Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma, Muscle Invasive Ureter Urothelial Carcinoma, Muscle Invasive Urethral Urothelial Carcinoma, Stage II Bladder Urothelial Carcinoma AJCC v6 and v7, Stage III Bladder Urothelial Carcinoma AJCC v6 and v7
- Being tested
- Biospecimen Collection, cfDNA or ctDNA Measurement, Computed Tomography, Cystoscopy, Magnetic Resonance Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo collection of tissue and blood
cfDNA or ctDNA MeasurementOther
Also called Cell-Free DNA/Circulating Tumor DNA Measurement, cfDNA/ctdDNA Measurement, cfDNA/ctDNA, cfDNA/ctDNA Measurement
Undergo ctDNA surveillance
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
CystoscopyProcedure or surgery
Also called CS
Undergo cystoscopy
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
NivolumabBiological
Also called ABP 206, BCD-263, BMS 936558, BMS-936558
Given IV
Questionnaire AdministrationOther
Ancillary studies
RelatlimabBiological
Also called BMS 986016, BMS-986016, BMS986016, Immunoglobulin G4, Anti-(human Lymphocyte Activation Gene-3 Protein) (Human Heavy Chain), Disulfide with Human Light Chain, Dimer
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Cohort A, Arm I (nivolumab) | Active comparator | Patients in Cohort A, Arm I 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 and may undergo cystoscopy throughout the trial. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Cystoscopy; Procedure: Magnetic Resonance Imaging; Biological: Nivolumab; Other: Questionnaire Administration |
| Cohort A, Arm II (nivolumab, relatlimab) | Experimental | Patients in Cohort A, Arm II 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 and may undergo cystoscopy throughout the trial. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Cystoscopy; Procedure: Magnetic Resonance Imaging; Biological: Nivolumab; Other: Questionnaire Administration; Biological: Relatlimab |
| Cohort B, Arm III (nivolumab) | Active comparator | Patients in Cohort B, Arm III 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 and may undergo cystoscopy throughout the trial. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Biological: Nivolumab; Other: Questionnaire Administration |
| Cohort B, Arm IV (ctDNA surveillance, nivolumab) | Experimental | Patients in Cohort B, Arm IV 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 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 and may undergo cystoscopy throughout the trial. Receives: Procedure: Biospecimen Collection; Other: cfDNA or ctDNA Measurement; Procedure: Computed Tomography; Procedure: Cystoscopy; Procedure: Magnetic Resonance Imaging; Biological: Nivolumab; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who are circulating tumor DNA negative (ctDNA[-]) (Cohort A Phase II)
Will be determined for each treatment arm as the number of patients who are ctDNA(-) after 12 weeks of treatment divided by the total number of patients on the treatment arm. Patients who do not have a 12-week ctDNA result will be deemed to be ctDNA(+). The comparison of the proportions of patients who are ctDNA(-) after 12 weeks of treatment between the two arms will be performed with a chi-square test.
Measured: At week 12 from treatment start date
Overall survival (OS) (Cohort A Phase III)
The analysis will be performed using a stratified log-rank test that uses the specified stratification variables. An additional analysis will be perform using a stratified Cox regression model to generate the point estimate and 90% confidence interval for the hazard ratio (HR) (comparing Arm 2 to Arm 1).
Measured: From randomization until death due to any cause, assessed up to 5 years after completion of study treatment
Disease-Free Survival (DFS) (Cohort B)
A stratified Cox model (using the randomization stratification variables will be used to generate a 90% confidence interval (CI) for the HR. If the 90% CI does not contain 1.39, Arm 4 (surveillance with ctDNA serial testing to determine whether patient is treated with nivolumab) will be deemed to be non-inferior to treating patients immediately with nivolumab.
Measured: From randomization until confirmed disease recurrence as assessed by the treating physician or death due to any cause, assessed up to 5 years after completion of study treatment
Secondary outcomes (8)
Proportion of patients who are ctDNA(-) (Cohort A Phase III) from treatment start date
Will be determined for each treatment arm as the number of patients who are ctDNA(-) after 12 weeks of treatment divided by the total number of patients on the treatment arm. Patients who do not have a 12-week ctDNA result will be deemed to be ctDNA(+).
Measured: At week 12
OS (Cohort A Phase II)
If the trial does not continue to phase III, OS will be a secondary endpoint.
Measured: From randomization until death due to any cause, assessed up to 5 years after completion of study treatment
DFS (Cohort A Phase II or III)
This will be a secondary endpoint for the phase III trial, if completed, or for the phase II trial if the phase III trial is not performed.
Measured: From randomization until confirmed disease recurrence as assessed by the treating physician or death due to any cause, assessed up to 5 years after completion of study treatment
Incidence of adverse events (Cohort A)
Will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. Adverse events (AEs) will be summarized with frequencies and relative frequencies. The maximum grade for an AE will be recorded for each patient by treatment arm. The number (percent) of patients that experience each observed adverse event will be summarized by treatment arm. In addition, the proportion of patients that experience a grade 3+, grade 4+, and grade 5 adverse event will be summarized as the number and percent of patients by treatment arm. The primary summary will be regardless of attribution.
Measured: Up to 5 years after completion of study treatment
OS (Cohort B)
Measured: From randomization until death due to any cause, assessed up to 5 years after completion of study treatment
Cumulative incidence of ctDNA(+) conversion (Cohort B)
Measured: From randomization until a patient becomes ctDNA(+), assessed up to 5 years after completion of study treatment
Lead time for ctDNA(+) conversion (Cohort B)
Measured: From when a patient becomes ctDNA(+) until a confirmed radiographic disease recurrence, assessed up to 5 years after completion of study treatment
Incidence of adverse events (Cohort B)
Will be assessed using CTCAE v5.0. Adverse events will be summarized with frequencies and relative frequencies. The maximum grade for an AE will be recorded for each patient by treatment arm. The number (percent) of patients that experience each observed adverse event will be summarized by treatment arm. In addition, the proportion of patients that experience a grade 3+, grade 4+, and grade 5 adverse event will be summarized as the number and percent of patients by treatment arm. The primary summary will be regardless of attribution.
Measured: Up to 5 years after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start2 Feb 2024
- Primary completion2 Sep 2030 (estimated)
- Study completion2 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Invasive Bladder Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 992 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Matthew D Galsky, Principal investigator, Alliance for Clinical Trials in Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987241
- Sponsor's protocol ID
- NCI-2023-05980
- Other IDs
- NCI-2023-05980, A032103, A032103, U10CA180821
- Status last verified
- Oct 2026
- First submitted
- 10 Aug 2023
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of ADjuvant ThErapy in URothelial CaNcer
- ClinicalTrials.gov ID
- NCT05987241
- Acronym / sponsor ID
- NCI-2023-05980
- Conditions
- Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma, Muscle Invasive Ureter Urothelial Carcinoma, Muscle Invasive Urethral Urothelial Carcinoma, Stage II Bladder Urothelial Carcinoma AJCC v6 and v7, Stage III Bladder Urothelial Carcinoma AJCC v6 and v7
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 992 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 2 Sep 2030 (estimated)
- Study completion
- 2 Sep 2030 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II/III trial examines whether patients who have undergone surgical removal of bladder, kidney, ureter or urethra, but require an additional treatment called immunotherapy to help prevent their urinary tract (urothelial) cancer from coming back, can be identified by a blood test. Many types of tumors tend to lose cells or release different types of cellular products including their DNA which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for disease progression or relapse. In this study, a blood test is used to measure ctDNA and see if there is still cancer somewhere in the body after surgery and if giving a treatment will help eliminate the cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and relatlimab, can help the body's immune system to attack the cancer, and can interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine if ctDNA measurement in blood can better identify patients that need additional treatment, if treatment with nivolumab prolongs patients' life and whether the additional immunotherapy treatment with relatlimab extends time without disease progression or prolongs life of urothelial cancer patients who have undergone surgical removal of their bladder, kidney, ureter or urethra.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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. VIII. To compare disease-free survival and overall survival in patients enrolled in Cohort A treated with adjuvant nivolumab versus nivolumab + relatlimab according to receipt of neoadjuvant immune checkpoint blockade-containing therapy versus no neoadjuvant immune checkpoint blockade-containing therapy.
IX. To compare disease-free survival and overall survival in patients enrolled in Cohort B treated with adjuvant nivolumab versus nivolumab + relatlimab according to receipt of neoadjuvant immune checkpoint blockade-containing therapy versus no neoadjuvant immune checkpoint blockade-containing therapy.
EXPLORATORY OBJECTIVES:
- 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-radical surgery treated with adjuvant nivolumab versus nivolumab + relatlimab.
III. To estimate the costs and value of care in patients with a ctDNA(-) assay post-radical surgery treated with adjuvant nivolumab versus surveillance with subsequent treatment with nivolumab at the time of conversion to ctDNA(+).
QUALITY OF LIFE OBJECTIVES:
- 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.
- 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.
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) and may undergo cystoscopy 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 and may undergo cystoscopy 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 and may undergo cystoscopy 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 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 and may undergo cystoscopy throughout the trial.
After completion of study treatment, patients are followed up at weeks 48, 60, 72, 84, 96, 120, 144, 196, and 248.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A, Arm I (nivolumab) | Active comparator | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Procedure: Cystoscopy, Procedure: Magnetic Resonance Imaging, Biological: Nivolumab, Other: Questionnaire AdministrationPatients in Cohort A, Arm I 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 and may undergo cystoscopy throughout the trial. |
| Cohort A, Arm II (nivolumab, relatlimab) | Experimental | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Procedure: Cystoscopy, Procedure: Magnetic Resonance Imaging, Biological: Nivolumab, Other: Questionnaire Administration, Biological: RelatlimabPatients in Cohort A, Arm II 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 and may undergo cystoscopy throughout the trial. |
| Cohort B, Arm III (nivolumab) | Active comparator | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Biological: Nivolumab, Other: Questionnaire AdministrationPatients in Cohort B, Arm III 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 and may undergo cystoscopy throughout the trial. |
| Cohort B, Arm IV (ctDNA surveillance, nivolumab) | Experimental | Procedure: Biospecimen Collection, Other: cfDNA or ctDNA Measurement, Procedure: Computed Tomography, Procedure: Cystoscopy, Procedure: Magnetic Resonance Imaging, Biological: Nivolumab, Other: Questionnaire AdministrationPatients in Cohort B, Arm IV 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 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 and may undergo cystoscopy throughout the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (69 listed)
- PRE-REGISTRATION (STEP 0): Histologically confirmed muscle-invasive urothelial carcinoma of the urethra, bladder, ureter or renal pelvis
- PRE-REGISTRATION (STEP 0): Variant histology, including neuroendocrine differentiation, sarcomatoid, micropapillary, glandular, trophoblastic, Mullerian, 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 (STEP 0): Radical surgery (cystectomy with lymph node dissection or nephroureterectomy or ureterectomy) must be ≥ 3 weeks and ≤ 12 weeks (central Signatera pathway) or ≤ 16 weeks (commercial Signatera pathwary) prior to pre-registration. Patients who have had a partial cystectomy as definitive therapy are not eligible
- PRE-REGISTRATION (STEP 0): Patients who have had a partial cystectomy as definitive therapy are not eligible
- PRE-REGISTRATION (STEP 0): 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo collection of tissue and blood | Procedure or surgery | Cohort A, Arm I (nivolumab), Cohort A, Arm II (nivolumab, relatlimab), Cohort B, Arm III (nivolumab), Cohort B, Arm IV (ctDNA surveillance, nivolumab) |
| cfDNA or ctDNA MeasurementAlso: Cell-Free DNA/Circulating Tumor DNA Measurement, cfDNA/ctdDNA Measurement, cfDNA/ctDNA, cfDNA/ctDNA MeasurementUndergo ctDNA surveillance | Other | Cohort B, Arm IV (ctDNA surveillance, nivolumab) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Cohort A, Arm I (nivolumab), Cohort A, Arm II (nivolumab, relatlimab), Cohort B, Arm III (nivolumab), Cohort B, Arm IV (ctDNA surveillance, nivolumab) |
| CystoscopyAlso: CSUndergo cystoscopy | Procedure or surgery | Cohort A, Arm I (nivolumab), Cohort A, Arm II (nivolumab, relatlimab), Cohort B, Arm IV (ctDNA surveillance, nivolumab) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo MRI | Procedure or surgery | Cohort A, Arm I (nivolumab), Cohort A, Arm II (nivolumab, relatlimab), Cohort B, Arm III (nivolumab), Cohort B, Arm IV (ctDNA surveillance, nivolumab) |
| NivolumabAlso: ABP 206, BCD-263, BMS 936558, BMS-936558Given IV | Biological | Cohort A, Arm I (nivolumab), Cohort A, Arm II (nivolumab, relatlimab), Cohort B, Arm III (nivolumab), Cohort B, Arm IV (ctDNA surveillance, nivolumab) |
| Questionnaire AdministrationAncillary studies | Other | Cohort A, Arm I (nivolumab), Cohort A, Arm II (nivolumab, relatlimab), Cohort B, Arm III (nivolumab), Cohort B, Arm IV (ctDNA surveillance, nivolumab) |
| RelatlimabAlso: BMS 986016, BMS-986016, BMS986016, Immunoglobulin G4, Anti-(human Lymphocyte Activation Gene-3 Protein) (Human Heavy Chain), Disulfide with Human Light Chain, DimerGiven IV | Biological | Cohort A, Arm II (nivolumab, relatlimab) |
Primary outcome
Proportion of patients who are circulating tumor DNA negative (ctDNA[-]) (Cohort A Phase II)
Time frame: At week 12 from treatment start date
Will be determined for each treatment arm as the number of patients who are ctDNA(-) after 12 weeks of treatment divided by the total number of patients on the treatment arm. Patients who do not have a 12-week ctDNA result will be deemed to be ctDNA(+). The comparison of the proportions of patients who are ctDNA(-) after 12 weeks of treatment between the two arms will be performed with a chi-square test.
Overall survival (OS) (Cohort A Phase III)
Time frame: From randomization until death due to any cause, assessed up to 5 years after completion of study treatment
The analysis will be performed using a stratified log-rank test that uses the specified stratification variables. An additional analysis will be perform using a stratified Cox regression model to generate the point estimate and 90% confidence interval for the hazard ratio (HR) (comparing Arm 2 to Arm 1).
Disease-Free Survival (DFS) (Cohort B)
Time frame: From randomization until confirmed disease recurrence as assessed by the treating physician or death due to any cause, assessed up to 5 years after completion of study treatment
A stratified Cox model (using the randomization stratification variables will be used to generate a 90% confidence interval (CI) for the HR. If the 90% CI does not contain 1.39, Arm 4 (surveillance with ctDNA serial testing to determine whether patient is treated with nivolumab) will be deemed to be non-inferior to treating patients immediately with nivolumab.
8 secondary outcomes
Proportion of patients who are ctDNA(-) (Cohort A Phase III) from treatment start date
Time frame: At week 12
OS (Cohort A Phase II)
Time frame: From randomization until death due to any cause, assessed up to 5 years after completion of study treatment
DFS (Cohort A Phase II or III)
Time frame: From randomization until confirmed disease recurrence as assessed by the treating physician or death due to any cause, assessed up to 5 years after completion of study treatment
Incidence of adverse events (Cohort A)
Time frame: Up to 5 years after completion of study treatment
OS (Cohort B)
Time frame: From randomization until death due to any cause, assessed up to 5 years after completion of study treatment
Cumulative incidence of ctDNA(+) conversion (Cohort B)
Time frame: From randomization until a patient becomes ctDNA(+), assessed up to 5 years after completion of study treatment
Lead time for ctDNA(+) conversion (Cohort B)
Time frame: From when a patient becomes ctDNA(+) until a confirmed radiographic disease recurrence, assessed up to 5 years after completion of study treatment
Incidence of adverse events (Cohort B)
Time frame: Up to 5 years after completion of study treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Yes. NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cancer Center at Saint Joseph's
Phoenix, United States
Matthew D Galsky principal investigator
Alliance for Clinical Trials in Oncology
505 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Biospecimen Collection, cfDNA or ctDNA Measurement and Computed Tomography in people with Muscle Invasive Bladder Urothelial Carcinoma and Muscle Invasive Renal Pelvis Urothelial Carcinoma, run by National Cancer Institute (NCI) at 505 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 69 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 505 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who are circulating tumor DNA negative (ctDNA[-]) (Cohort A Phase II) (time frame: At week 12 from treatment start date). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.