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Taking people in United StatesPhase 2/3

Blood test of tumor DNA to guide immunotherapy after urothelial cancer surgery

Tests a blood marker and nivolumab with relatlimab in adults after urothelial cancer surgery.

Plain-language title generated from the registry record
Registry title: 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

Key facts

Where
Albemarle, Albuquerque, Allentown, Altoona, Ames, Anaconda, Anaheim, Anderson, Ankeny, Ann Arbor, Appleton, Athens, Atlanta, Aurora, Aventura, Avon, Baldwin Park, Ballwin, Baltimore, Barrington, Basking Ridge, Baton Rouge, Battle Creek, Bay City, Beaver, Bellevue, Bellflower, Bemidji, Berlin Corners, Bethlehem, Bettendorf, Beverly, Billings, Bismarck, Bloomington, Boiling Springs, Boise, Boone, Boston, Bozeman, Brewer, Bridgeport, Brighton, Brooklyn, Brownstown, Buffalo, Burlington, Caldwell, Canton, Cape Girardeau, Carthage, Cary, Chapel Hill, Charleston, Charlotte, Charlottesville, Chelsea, Cherry Hill, Chicago, Cincinnati, City of Saint Peters, Clemmons, Clinton Township, Clive, Coeur d'Alene, Columbia, Columbus, Commack, Concord, Coon Rapids, Coral Gables, Creve Coeur, Crown Point, Crystal Lake, Cudahy, Cumberland, Dallas, Danville, Dearborn, Decatur, Deerfield Beach, DeKalb, Delaware, Denver, Derby, Des Moines, Detroit, Dixon, Downers Grove, Dublin, Duluth, Durham, Easley, East Stroudsburg, Eau Claire, Edina, Effingham, Elgin, Elmhurst, Erie, Escanaba, Eureka, Evanston, Fairfield, Fargo, Farmington, Farmington Hills, Fayetteville, Flint, Flushing, Fontana, Forest City, Fort Collins, Fort Dodge, Fort Worth, Foxborough, Frederick, Fremont, Fresno, Gaffney, Gainesville, Galesburg, Gastonia, Geneva, Germantown, Glastonbury, Glens Falls, Glenview, Gloucester, Grafton, Grand Rapids, Grayslake, Great Falls, Greeley, Green Bay, Greensburg, Greenville, Greenwich, Greer, Guilford, Hackensack, Harbor City, Harrisburg, Harrison, Hartford, Harvey, Hays, Hazel Crest, Highland Park, Highlands Ranch, Hollywood, Honolulu, Houston, Huntersville, Indianapolis, Iowa City, Irvine, Jackson, Jacksonville, Jefferson, Jefferson City, Jersey City, Johns Creek, Kalamazoo, Kalispell, Kansas City, Kewanee, La Jolla, Lafayette, Lake Forest, Lakewood, Lancaster, Lansing, Las Vegas, Lawrence, Lawrenceville, Lawton, Lee's Summit, Lexington, Libertyville, Lincolnton, Livingston, Livonia, Lone Tree, Long Branch, Los Angeles, Louisville, Loveland, Macomb, Madison, Manahawkin, Manchester, Mansfield, Marinette, Marion, Marshalltown, Marshfield, Matthews, Mattoon, Mechanicsburg, Mechanicsville, Meriden, Metairie, Miami, Miami Beach, Middletown, Midlothian, Milford, Milwaukee, Mineola, Minneapolis, Missoula, Modesto, Monroe, Monroeville, Montvale, Morgantown, Mukwonago, Muskegon, Nampa, Naperville, Nashville, New Britain, New Brunswick, New Castle, New Haven, New Lenox, New Orleans, New York, Newark, Newport Beach, Niles, North Haven, North Kansas City, North Miami, Norton Shores, Novi, O'Fallon, Oak Brook, Oak Lawn, Oakland, Oconomowoc, Oconto Falls, Oklahoma City, Olathe, Omaha, Ontario, Oregon City, Orland Park, Orlando, Oshkosh, Ottawa, Overland Park, Palo Alto, Panorama City, Park Ridge, Peabody, Pekin, Pembroke Pines, Peoria, Peru, Petoskey, Philadelphia, Phoenix, Pickerington, Pinehurst, Pittsburgh, Plainfield, Plantation, Pontiac, Portland, Post Falls, Princeton, Raleigh, Reed City, Rice Lake, Richardson, Richmond, Rio Rancho, Riverside, Rochester, Rock Hill, Rockford, Rogers, Roseville, Sacramento, Saginaw, Saint Cloud, Saint Joseph, Saint Louis Park, Saint Paul, Sainte Genevieve, Salina, Salt Lake City, San Diego, San Francisco, San Jose, San Leandro, San Marcos, San Rafael, Sandpoint, Santa Clara, Santa Monica, Santa Rosa, Seattle, Seneca, Sewell, Sheboygan, Shelby, Shiloh, Sioux Falls, Somerville, South Hill, South San Francisco, South Weymouth, Spartanburg, Springdale, Springfield, St Louis, Stamford, Stevens Point, Stony Brook, Sturgeon Bay, Sullivan, Summit, Sylvania, Tawas City, The Bronx, Toms River, Topeka, Torrington, Traverse City, Trumbull, Tucson, Tulsa, Two Rivers, Union, Uniondale, Urbana, Vallejo, Walnut Creek, Warrenville, Washington, Washington D.C., Waterbury, Waterford, Waukee, Waukesha, Wauwatosa, Webster, West Allis, West Bloomfield, West Branch, West Chester, West Reading, Westerly, Westerville, Weston, Westwood, Willow Grove, Winchester, Winston-Salem, Woodland Hills, Wyandotte, Wyoming, and Ypsilanti, United StatesSee the 495 sites
Phase
Phase 2/3

Where in United States

  • Atrium Health Stanly/LCI-AlbemarleAlbemarle, United StatesTaking people
  • Presbyterian Kaseman HospitalAlbuquerque, United StatesTaking people
  • University of New Mexico Cancer CenterAlbuquerque, United StatesTaking people
  • Lehigh Valley Hospital-Cedar CrestAllentown, United StatesTaking people
  • UPMC AltoonaAltoona, United StatesTaking people
  • Mary Greeley Medical CenterAmes, United StatesTaking people
  • McFarland Clinic - AmesAmes, United StatesTaking people
  • Community Hospital of AnacondaAnaconda, United StatesTaking people
  • Kaiser Permanente-AnaheimAnaheim, United StatesTaking people
  • AnMed Health Cancer CenterAnderson, United StatesTaking people
  • UI Health Care Mission Cancer and Blood - Ankeny ClinicAnkeny, United StatesTaking people
  • Trinity Health Saint Joseph Mercy Hospital Ann ArborAnn Arbor, United StatesTaking people
  • University of Michigan Rogel Cancer CenterAnn Arbor, United StatesTaking people
  • ThedaCare Regional Cancer CenterAppleton, United StatesTaking people
  • OhioHealth O'Bleness HospitalAthens, United StatesNo longer taking part
  • Emory Saint Joseph's HospitalAtlanta, United StatesTaking people
  • Emory University Hospital MidtownAtlanta, United StatesTaking people
  • Emory University Hospital/Winship Cancer InstituteAtlanta, United StatesTaking people
  • Grady Health SystemAtlanta, United StatesTaking people
  • Northside HospitalAtlanta, United StatesTaking people
  • UCHealth University of Colorado HospitalAurora, United StatesTaking people
  • Mount Sinai Comprehensive Cancer Center at AventuraAventura, United StatesTaking people
  • UM Sylvester Comprehensive Cancer Center at AventuraAventura, United StatesNo longer taking part
  • Hartford HealthCare - AvonAvon, United StatesTaking people
  • Kaiser Permanente-Baldwin ParkBaldwin Park, United StatesTaking people
  • Mercy Oncology and Hematology - Clayton-ClarksonBallwin, United StatesTaking people
  • Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimore, United StatesTaking people
  • University of Maryland/Greenebaum Cancer CenterBaltimore, United StatesTaking people
  • Advocate Good Shepherd HospitalBarrington, United StatesTaking people
  • Memorial Sloan Kettering Basking RidgeBasking Ridge, United StatesTaking people
  • Louisiana Hematology Oncology Associates LLCBaton Rouge, United StatesTaking people
  • Bronson Battle CreekBattle Creek, United StatesTaking people
  • McLaren Cancer Institute-Bay CityBay City, United StatesTaking people
  • UPMC-Heritage Valley Health System BeaverBeaver, United StatesTaking people
  • Nebraska Medicine-BellevueBellevue, United StatesTaking people
  • Kaiser Permanente-BellflowerBellflower, United StatesTaking people
  • Sanford Joe Lueken Cancer CenterBemidji, United StatesTaking people
  • Central Vermont Medical Center/National Life Cancer TreatmentBerlin Corners, United StatesTaking people
  • Lehigh Valley Hospital - MuhlenbergBethlehem, United StatesTaking people
  • University of Iowa Healthcare Cancer Services Quad CitiesBettendorf, United StatesNo longer taking part
  • Beverly HospitalBeverly, United StatesTaking people
  • Billings Clinic Cancer CenterBillings, United StatesTaking people
  • Sanford Bismarck Medical CenterBismarck, United StatesTaking people
  • Illinois CancerCare-BloomingtonBloomington, United StatesTaking people
  • Prisma Health Cancer Institute - SpartanburgBoiling Springs, United StatesTaking people
  • Saint Alphonsus Cancer Care Center-BoiseBoise, United StatesTaking people
  • McFarland Clinic - BooneBoone, United StatesNo longer taking part
  • Beth Israel Deaconess Medical CenterBoston, United StatesTaking people
  • Dana-Farber Cancer InstituteBoston, United StatesTaking people
  • Bozeman Health Deaconess HospitalBozeman, United StatesTaking people
  • Lafayette Family Cancer Center-EMMCBrewer, United StatesTaking people
  • Hartford HealthCare - Saint Vincent's Medical CenterBridgeport, United StatesTaking people
  • Dana-Farber Cancer Institute at Boston Medical Center - BrightonBrighton, United StatesTaking people
  • Trinity Health IHA Medical Group Hematology Oncology - BrightonBrighton, United StatesTaking people
  • University of Michigan - Brighton Center for Specialty CareBrighton, United StatesTaking people
  • Maimonides Medical CenterBrooklyn, United StatesTaking people
  • Henry Ford Cancer Institute-DownriverBrownstown, United StatesTaking people
  • Roswell Park Cancer InstituteBuffalo, United StatesNo longer taking part
  • Lahey ClinicBurlington, United StatesTaking people
  • University of Vermont and State Agricultural CollegeBurlington, United StatesTaking people
  • University of Vermont Medical CenterBurlington, United StatesTaking people
  • Saint Alphonsus Cancer Care Center-CaldwellCaldwell, United StatesTaking people
  • Illinois CancerCare-CantonCanton, United StatesTaking people
  • Trinity Health IHA Medical Group Hematology Oncology - CantonCanton, United StatesTaking people
  • Saint Francis Medical CenterCape Girardeau, United StatesTaking people
  • Illinois CancerCare-CarthageCarthage, United StatesTaking people
  • Duke Cancer Center CaryCary, United StatesNo longer taking part
  • UNC Lineberger Comprehensive Cancer CenterChapel Hill, United StatesTaking people
  • Medical University of South CarolinaCharleston, United StatesTaking people
  • Vandalia Health/CAMC Institute for Academic MedicineCharleston, United StatesTaking people
  • Atrium Health Pineville/LCI-PinevilleCharlotte, United StatesTaking people
  • Atrium Health University City/LCI-UniversityCharlotte, United StatesTaking people
  • Carolinas Medical Center/Levine Cancer InstituteCharlotte, United StatesTaking people
  • Levine Cancer Institute-BallantyneCharlotte, United StatesTaking people
  • Levine Cancer Institute-SouthParkCharlotte, United StatesTaking people
  • University of Virginia Cancer CenterCharlottesville, United StatesTaking people
  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalChelsea, United StatesTaking people
  • Jefferson Cherry Hill HospitalCherry Hill, United StatesTaking people
  • Advocate Illinois Masonic Medical CenterChicago, United StatesTaking people
  • Northwestern UniversityChicago, United StatesTaking people
  • Swedish Covenant HospitalChicago, United StatesTaking people
  • University of Chicago Comprehensive Cancer CenterChicago, United StatesTaking people
  • University of IllinoisChicago, United StatesTaking people
  • University of Cincinnati Cancer Center-UC Medical CenterCincinnati, United StatesTaking people
  • Siteman Cancer Center at Saint Peters HospitalCity of Saint Peters, United StatesTaking people
  • Wake Forest University at ClemmonsClemmons, United StatesTaking people
  • Henry Ford Macomb Hospital-Clinton TownshipClinton Township, United StatesTaking people
  • UI Health Care Mission Cancer and Blood - West Des Moines ClinicClive, United StatesTaking people
  • Kootenai Health - Coeur d'AleneCoeur d'Alene, United StatesTaking people
  • MU Health - University Hospital/Ellis Fischel Cancer CenterColumbia, United StatesTaking people
  • Ohio State University Comprehensive Cancer CenterColumbus, United StatesTaking people
  • Columbus Oncology and Hematology Associates IncColumbus, United StatesNo longer taking part
  • Doctors HospitalColumbus, United StatesNo longer taking part
  • Grant Medical CenterColumbus, United StatesNo longer taking part
  • Riverside Methodist HospitalColumbus, United StatesNo longer taking part
  • Memorial Sloan Kettering CommackCommack, United StatesTaking people
  • Atrium Health Cabarrus/LCI-ConcordConcord, United StatesTaking people
  • New Hampshire Oncology Hematology PA-ConcordConcord, United StatesNo longer taking part
  • Mercy HospitalCoon Rapids, United StatesTaking people
  • UM Sylvester Comprehensive Cancer Center at Coral GablesCoral Gables, United StatesTaking people
  • Siteman Cancer Center at West County HospitalCreve Coeur, United StatesTaking people
  • UChicago Medicine Northwest IndianaCrown Point, United StatesTaking people
  • AMG Crystal Lake - OncologyCrystal Lake, United StatesTaking people
  • Aurora Saint Luke's South ShoreCudahy, United StatesTaking people
  • UPMC Western MarylandCumberland, United StatesTaking people
  • UT Southwestern Simmons Cancer Center - RedBirdDallas, United StatesTaking people
  • UT Southwestern/Simmons Cancer Center-DallasDallas, United StatesTaking people
  • Carle at The RiverfrontDanville, United StatesTaking people
  • Henry Ford Medical Center-FairlaneDearborn, United StatesTaking people
  • Cancer Care Specialists of Illinois - DecaturDecatur, United StatesTaking people
  • Decatur Memorial HospitalDecatur, United StatesTaking people
  • UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield Beach, United StatesTaking people
  • Northwestern Medicine Cancer Center KishwaukeeDeKalb, United StatesTaking people
  • Delaware Health Center-Grady Cancer CenterDelaware, United StatesNo longer taking part
  • Grady Memorial HospitalDelaware, United StatesNo longer taking part
  • Kaiser Permanente-FranklinDenver, United StatesTaking people
  • Smilow Cancer Hospital-Derby Care CenterDerby, United StatesTaking people
  • Iowa Methodist Medical CenterDes Moines, United StatesTaking people
  • Mercy Medical Center - Des MoinesDes Moines, United StatesTaking people
  • UI Health Care Mission Cancer and Blood - Des Moines ClinicDes Moines, United StatesTaking people
  • UI Health Care Mission Cancer and Blood - Laurel ClinicDes Moines, United StatesTaking people
  • Henry Ford HospitalDetroit, United StatesTaking people
  • Wayne State University/Karmanos Cancer InstituteDetroit, United StatesTaking people
  • Illinois CancerCare-DixonDixon, United StatesTaking people
  • Advocate Good Samaritan HospitalDowners Grove, United StatesTaking people
  • Kaiser Permanente DublinDublin, United StatesTaking people
  • Columbus Oncology and Hematology AssociatesDublin, United StatesNo longer taking part
  • Dublin Methodist HospitalDublin, United StatesNo longer taking part
  • Northside Hospital - DuluthDuluth, United StatesTaking people
  • Duke Cancer Center SouthpointDurham, United StatesTaking people
  • Duke University Medical CenterDurham, United StatesTaking people
  • Prisma Health Cancer Institute - EasleyEasley, United StatesTaking people
  • Pocono Medical CenterEast Stroudsburg, United StatesTaking people
  • Marshfield Medical Center-EC Cancer CenterEau Claire, United StatesTaking people
  • Fairview Southdale HospitalEdina, United StatesTaking people
  • Minnesota Oncology - EdinaEdina, United StatesTaking people
  • Carle Physician Group-EffinghamEffingham, United StatesTaking people
  • Crossroads Cancer CenterEffingham, United StatesTaking people
  • Advocate Sherman HospitalElgin, United StatesTaking people
  • Elmhurst Memorial HospitalElmhurst, United StatesNo longer taking part
  • UPMC Hillman Cancer Center ErieErie, United StatesTaking people
  • OSF Saint Francis Hospital and Medical GroupEscanaba, United StatesTaking people
  • Illinois CancerCare-EurekaEureka, United StatesTaking people
  • NorthShore University HealthSystem-Evanston HospitalEvanston, United StatesTaking people
  • Hartford Healthcare - FairfieldFairfield, United StatesTaking people
  • Smilow Cancer Hospital Care Center-FairfieldFairfield, United StatesTaking people
  • Sanford Broadway Medical CenterFargo, United StatesTaking people
  • Sanford Roger Maris Cancer CenterFargo, United StatesTaking people
  • Parkland Health Center - FarmingtonFarmington, United StatesTaking people
  • Weisberg Cancer Treatment CenterFarmington Hills, United StatesTaking people
  • Highlands Oncology Group - FayettevilleFayetteville, United StatesTaking people
  • Cancer Hematology Centers - FlintFlint, United StatesTaking people
  • Genesys Hurley Cancer InstituteFlint, United StatesTaking people
  • Hurley Medical CenterFlint, United StatesTaking people
  • Genesee Hematology Oncology PCFlint, United StatesNo longer taking part
  • The New York Hospital Medical Center of QueensFlushing, United StatesTaking people
  • Kaiser Permanente-FontanaFontana, United StatesTaking people
  • Levine Cancer Institute - RutherfordForest City, United StatesTaking people
  • Cancer Care and Hematology-Fort CollinsFort Collins, United StatesTaking people
  • Poudre Valley HospitalFort Collins, United StatesTaking people
  • McFarland Clinic - Trinity Cancer CenterFort Dodge, United StatesTaking people
  • UT Southwestern/Simmons Cancer Center-Fort WorthFort Worth, United StatesTaking people
  • Dana-Farber Cancer Institute at FoxboroughFoxborough, United StatesTaking people
  • FMH James M Stockman Cancer InstituteFrederick, United StatesTaking people
  • Kaiser Permanente-FremontFremont, United StatesTaking people
  • Kaiser Permanente Fresno Orchard PlazaFresno, United StatesTaking people
  • Kaiser Permanente-FresnoFresno, United StatesTaking people
  • Gibbs Cancer Center-GaffneyGaffney, United StatesTaking people
  • Malcom Randall Veterans Administration Medical CenterGainesville, United StatesTaking people
  • UF Health Cancer Institute - GainesvilleGainesville, United StatesTaking people
  • Illinois CancerCare-GalesburgGalesburg, United StatesTaking people
  • Levine Cancer Institute-GastonGastonia, United StatesTaking people
  • Northwestern Medicine Cancer Center DelnorGeneva, United StatesTaking people
  • The West Clinic - Wolf RiverGermantown, United StatesNo longer taking part
  • Smilow Cancer Hospital Care Center at GlastonburyGlastonbury, United StatesNo longer taking part
  • Glens Falls HospitalGlens Falls, United StatesTaking people
  • NorthShore University HealthSystem-Glenbrook HospitalGlenview, United StatesTaking people
  • Northwestern Medicine Glenview Outpatient CenterGlenview, United StatesTaking people
  • Addison Gilbert HospitalGloucester, United StatesTaking people
  • Aurora Cancer Care-GraftonGrafton, United StatesTaking people
  • Corewell Health Grand Rapids Hospitals - Butterworth HospitalGrand Rapids, United StatesTaking people
  • Trinity Health Grand Rapids HospitalGrand Rapids, United StatesTaking people
  • Northwestern Medicine Grayslake Outpatient CenterGrayslake, United StatesTaking people
  • Benefis Sletten Cancer InstituteGreat Falls, United StatesTaking people
  • UCHealth Greeley HospitalGreeley, United StatesTaking people
  • Aurora BayCare Medical CenterGreen Bay, United StatesTaking people
  • Saint Vincent Hospital Cancer Center at Saint Mary'sGreen Bay, United StatesTaking people
  • Saint Vincent Hospital Cancer Center Green BayGreen Bay, United StatesTaking people
  • UPMC Cancer Centers - Arnold Palmer PavilionGreensburg, United StatesTaking people
  • Prisma Health Cancer Institute - ButternutGreenville, United StatesTaking people
  • Prisma Health Cancer Institute - EastsideGreenville, United StatesTaking people
  • Prisma Health Cancer Institute - FarisGreenville, United StatesTaking people
  • Prisma Health Greenville Memorial HospitalGreenville, United StatesTaking people
  • Smilow Cancer Hospital Care Center at GreenwichGreenwich, United StatesTaking people
  • Gibbs Cancer Center-PelhamGreer, United StatesTaking people
  • Prisma Health Cancer Institute - GreerGreer, United StatesTaking people
  • Smilow Cancer Hospital Care Center - GuilfordGuilford, United StatesTaking people
  • Hackensack University Medical CenterHackensack, United StatesTaking people
  • Kaiser Permanente South BayHarbor City, United StatesTaking people
  • UPMC Pinnacle Cancer Center/Community Osteopathic CampusHarrisburg, United StatesTaking people
  • Memorial Sloan Kettering WestchesterHarrison, United StatesTaking people
  • Hartford HospitalHartford, United StatesTaking people
  • Smilow Cancer Hospital Care Center at Saint FrancisHartford, United StatesNo longer taking part
  • Ingalls Memorial HospitalHarvey, United StatesTaking people
  • HaysMedHays, United StatesTaking people
  • Advocate South Suburban HospitalHazel Crest, United StatesTaking people
  • NorthShore University HealthSystem-Highland Park HospitalHighland Park, United StatesTaking people
  • UCHealth Highlands Ranch HospitalHighlands Ranch, United StatesTaking people
  • Memorial Regional Hospital/Joe DiMaggio Children's HospitalHollywood, United StatesTaking people
  • Kaiser Permanente Moanalua Medical CenterHonolulu, United StatesTaking people
  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterHouston, United StatesTaking people
  • Ben Taub General HospitalHouston, United StatesTaking people
  • Lyndon Baines Johnson General HospitalHouston, United StatesTaking people
  • Michael E. DeBakey VA Medical CenterHouston, United StatesTaking people
  • Levine Cancer Institute - HuntersvilleHuntersville, United StatesTaking people
  • Indiana University/Melvin and Bren Simon Cancer CenterIndianapolis, United StatesTaking people
  • University of Iowa/Holden Comprehensive Cancer CenterIowa City, United StatesTaking people
  • Kaiser Permanente-IrvineIrvine, United StatesTaking people
  • Allegiance HealthJackson, United StatesTaking people
  • University of Mississippi Medical CenterJackson, United StatesTaking people
  • Mayo Clinic in FloridaJacksonville, United StatesTaking people
  • McFarland Clinic - JeffersonJefferson, United StatesNo longer taking part
  • MU Health Care Goldschmidt Cancer CenterJefferson City, United StatesNo longer taking part
  • Jersey City Medical CenterJersey City, United StatesTaking people
  • Emory Johns Creek HospitalJohns Creek, United StatesTaking people
  • Bronson Methodist HospitalKalamazoo, United StatesTaking people
  • West Michigan Cancer CenterKalamazoo, United StatesTaking people
  • Logan Health Medical CenterKalispell, United StatesTaking people
  • University Health Truman Medical CenterKansas City, United StatesTaking people
  • University of Kansas Cancer CenterKansas City, United StatesTaking people
  • University of Kansas Cancer Center - BriarcliffKansas City, United StatesTaking people
  • University of Kansas Cancer Center - NorthKansas City, United StatesTaking people
  • Kansas City Veterans Affairs Medical CenterKansas City, United StatesNo longer taking part
  • Illinois CancerCare-Kewanee ClinicKewanee, United StatesTaking people
  • UC San Diego Moores Cancer CenterLa Jolla, United StatesTaking people
  • Kaiser Permanente-Rock CreekLafayette, United StatesTaking people
  • Northwestern Medicine Lake Forest HospitalLake Forest, United StatesTaking people
  • Monmouth Medical Center Southern CampusLakewood, United StatesTaking people
  • Lancaster General Ann B Barshinger Cancer InstituteLancaster, United StatesNo longer taking part
  • Karmanos Cancer Institute at McLaren Greater LansingLansing, United StatesTaking people
  • University of Michigan Health - Sparrow LansingLansing, United StatesTaking people
  • OptumCare Cancer Care at CharlestonLas Vegas, United StatesNo longer taking part
  • OptumCare Cancer Care at Fort ApacheLas Vegas, United StatesNo longer taking part
  • Lawrence Memorial HospitalLawrence, United StatesTaking people
  • Northside Hospital - GwinnettLawrenceville, United StatesTaking people
  • Cancer Centers of Southwest Oklahoma ResearchLawton, United StatesTaking people
  • University of Kansas Cancer Center - Lee's SummitLee's Summit, United StatesTaking people
  • University of Kentucky/Markey Cancer CenterLexington, United StatesTaking people
  • AMG Libertyville - OncologyLibertyville, United StatesTaking people
  • Condell Memorial HospitalLibertyville, United StatesTaking people
  • Atrium Health Lincoln/LCI-LincolntonLincolnton, United StatesTaking people
  • Cooperman Barnabas Medical CenterLivingston, United StatesTaking people
  • Trinity Health Saint Mary Mercy Livonia HospitalLivonia, United StatesTaking people
  • Kaiser Permanente-Lone TreeLone Tree, United StatesTaking people
  • UCHealth Lone Tree Health CenterLone Tree, United StatesTaking people
  • Monmouth Medical CenterLong Branch, United StatesTaking people
  • Kaiser Permanente Los Angeles Medical CenterLos Angeles, United StatesTaking people
  • Kaiser Permanente West Los AngelesLos Angeles, United StatesTaking people
  • UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, United StatesTaking people
  • Keck Medicine of USC KoreatownLos Angeles, United StatesNo longer taking part
  • Los Angeles General Medical CenterLos Angeles, United StatesNo longer taking part
  • USC / Norris Comprehensive Cancer CenterLos Angeles, United StatesNo longer taking part
  • The James Graham Brown Cancer Center at University of LouisvilleLouisville, United StatesTaking people
  • UofL Health Medical Center NortheastLouisville, United StatesTaking people
  • Baptist Health LouisvilleLouisville, United StatesNo longer taking part
  • Medical Center of the RockiesLoveland, United StatesTaking people
  • Illinois CancerCare-MacombMacomb, United StatesTaking people
  • University of Wisconsin Carbone Cancer Center - Eastpark Medical CenterMadison, United StatesTaking people
  • University of Wisconsin Carbone Cancer Center - University HospitalMadison, United StatesTaking people
  • Southern Ocean County Medical CenterManahawkin, United StatesTaking people
  • Hartford HealthCare - ManchesterManchester, United StatesTaking people
  • Solinsky Center for Cancer CareManchester, United StatesNo longer taking part
  • OhioHealth Mansfield HospitalMansfield, United StatesNo longer taking part
  • Aurora Bay Area Medical Group-MarinetteMarinette, United StatesTaking people
  • OhioHealth Marion General HospitalMarion, United StatesNo longer taking part
  • McFarland Clinic - MarshalltownMarshalltown, United StatesTaking people
  • Marshfield Medical Center-MarshfieldMarshfield, United StatesTaking people
  • Levine Cancer Institute - Union WestMatthews, United StatesTaking people
  • Carle Physician Group-Mattoon/CharlestonMattoon, United StatesTaking people
  • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer PavilionMechanicsburg, United StatesTaking people
  • Bon Secours Memorial Regional Medical CenterMechanicsville, United StatesTaking people
  • Midstate Medical CenterMeriden, United StatesTaking people
  • Mary Bird Perkins Cancer Center - MetairieMetairie, United StatesTaking people
  • Miami Cancer InstituteMiami, United StatesTaking people
  • UM Sylvester Comprehensive Cancer Center at KendallMiami, United StatesTaking people
  • University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, United StatesTaking people
  • Mount Sinai Medical CenterMiami Beach, United StatesTaking people
  • Memorial Sloan Kettering MonmouthMiddletown, United StatesTaking people
  • Bon Secours Saint Francis Medical CenterMidlothian, United StatesTaking people
  • Dana-Farber/Brigham and Women's Cancer Center at Milford RegionalMilford, United StatesTaking people
  • Aurora Saint Luke's Medical CenterMilwaukee, United StatesTaking people
  • Aurora Sinai Medical CenterMilwaukee, United StatesTaking people
  • Medical College of WisconsinMilwaukee, United StatesTaking people
  • NYU Langone Hospital - Long IslandMineola, United StatesNo longer taking part
  • Abbott-Northwestern HospitalMinneapolis, United StatesTaking people
  • Hennepin County Medical CenterMinneapolis, United StatesTaking people
  • Community Medical CenterMissoula, United StatesTaking people
  • Kaiser Permanente- Modesto MOB IIModesto, United StatesTaking people
  • Kaiser Permanente-ModestoModesto, United StatesTaking people
  • Atrium Health Union/LCI-UnionMonroe, United StatesTaking people
  • UPMC Hillman Cancer Center - MonroevilleMonroeville, United StatesTaking people
  • Memorial Sloan Kettering BergenMontvale, United StatesTaking people
  • West Virginia University HealthcareMorgantown, United StatesTaking people
  • ProHealth D N Greenwald CenterMukwonago, United StatesTaking people
  • Trinity Health Muskegon HospitalMuskegon, United StatesTaking people
  • Saint Alphonsus Cancer Care Center-NampaNampa, United StatesTaking people
  • Edward Hospital/Cancer CenterNaperville, United StatesNo longer taking part
  • Vanderbilt University/Ingram Cancer CenterNashville, United StatesTaking people
  • The Hospital of Central ConnecticutNew Britain, United StatesTaking people
  • Rutgers Cancer Institute of New JerseyNew Brunswick, United StatesTaking people
  • UPMC Hillman Cancer Center - New CastleNew Castle, United StatesTaking people
  • Yale UniversityNew Haven, United StatesTaking people
  • UC Comprehensive Cancer Center at Silver CrossNew Lenox, United StatesTaking people
  • Ochsner Medical Center JeffersonNew Orleans, United StatesTaking people
  • Memorial Sloan-Kettering Cancer CenterNew York, United StatesTaking people
  • Mount Sinai ChelseaNew York, United StatesTaking people
  • Mount Sinai HospitalNew York, United StatesTaking people
  • NYP/Weill Cornell Medical CenterNew York, United StatesTaking people
  • Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew York, United StatesNo longer taking part
  • Helen F Graham Cancer CenterNewark, United StatesTaking people
  • Medical Oncology Hematology Consultants PANewark, United StatesTaking people
  • USC Norris Oncology/Hematology-Newport BeachNewport Beach, United StatesNo longer taking part
  • Corewell Health Lakeland Hospitals - Niles HospitalNiles, United StatesTaking people
  • Yale-New Haven Hospital North Haven Medical CenterNorth Haven, United StatesTaking people
  • University of Kansas Cancer Center at North Kansas City HospitalNorth Kansas City, United StatesNo longer taking part
  • University of Miami Sylvester Comprehensive Cancer Center at Sole MiaNorth Miami, United StatesTaking people
  • Cancer and Hematology Centers of Western Michigan - Norton ShoresNorton Shores, United StatesTaking people
  • Henry Ford Medical Center-ColumbusNovi, United StatesTaking people
  • Cancer Care Center of O'FallonO'Fallon, United StatesTaking people
  • Northwestern Medicine Oak BrookOak Brook, United StatesTaking people
  • Advocate Christ Medical CenterOak Lawn, United StatesTaking people
  • Kaiser Permanente-OaklandOakland, United StatesTaking people
  • ProHealth Oconomowoc Memorial HospitalOconomowoc, United StatesTaking people
  • Saint Vincent Hospital Cancer Center at Oconto FallsOconto Falls, United StatesTaking people
  • University of Oklahoma Health Sciences CenterOklahoma City, United StatesTaking people
  • The University of Kansas Cancer Center - OlatheOlathe, United StatesTaking people
  • Nebraska Medicine-Village PointeOmaha, United StatesTaking people
  • University of Nebraska Medical CenterOmaha, United StatesTaking people
  • Kaiser Permanente-OntarioOntario, United StatesTaking people
  • Saint Alphonsus Cancer Care Center-OntarioOntario, United StatesTaking people
  • Providence Willamette Falls Medical CenterOregon City, United StatesTaking people
  • Northwestern Medicine Orland ParkOrland Park, United StatesTaking people
  • University of Chicago Medicine-Orland ParkOrland Park, United StatesTaking people
  • AdventHealth OrlandoOrlando, United StatesTaking people
  • Vince Lombardi Cancer Clinic - OshkoshOshkosh, United StatesTaking people
  • Illinois CancerCare-Ottawa ClinicOttawa, United StatesTaking people
  • University of Kansas Cancer Center-Overland ParkOverland Park, United StatesTaking people
  • Stanford Cancer Institute Palo AltoPalo Alto, United StatesTaking people
  • Kaiser Permanente - Panorama CityPanorama City, United StatesTaking people
  • Advocate Lutheran General HospitalPark Ridge, United StatesTaking people
  • Lahey Clinic PeabodyPeabody, United StatesTaking people
  • Illinois CancerCare-PekinPekin, United StatesTaking people
  • Memorial Hospital WestPembroke Pines, United StatesTaking people
  • Illinois CancerCare-PeoriaPeoria, United StatesTaking people
  • Illinois CancerCare-PeruPeru, United StatesTaking people
  • McLaren Cancer Institute-Northern MichiganPetoskey, United StatesTaking people
  • Jefferson Torresdale HospitalPhiladelphia, United StatesTaking people
  • Thomas Jefferson University HospitalPhiladelphia, United StatesTaking people
  • University of Pennsylvania/Abramson Cancer CenterPhiladelphia, United StatesNo longer taking part
  • Cancer Center at Saint Joseph'sPhoenix, United StatesTaking people
  • Mayo Clinic Hospital in ArizonaPhoenix, United StatesTaking people
  • OhioHealth Pickerington Methodist HospitalPickerington, United StatesNo longer taking part
  • FirstHealth of the Carolinas-Moore Regional HospitalPinehurst, United StatesTaking people
  • UPMC Hillman Cancer CenterPittsburgh, United StatesTaking people
  • UPMC-Passavant HospitalPittsburgh, United StatesTaking people
  • UPMC-Saint Clair Hospital Cancer CenterPittsburgh, United StatesTaking people
  • UPMC-Saint MargaretPittsburgh, United StatesTaking people
  • Edward Hospital/Cancer Center?PlainfieldPlainfield, United StatesNo longer taking part
  • UM Sylvester Comprehensive Cancer Center at PlantationPlantation, United StatesTaking people
  • Trinity Health Saint Joseph Mercy Oakland HospitalPontiac, United StatesTaking people
  • Oregon Health and Science UniversityPortland, United StatesTaking people
  • Providence Portland Medical CenterPortland, United StatesTaking people
  • Providence Saint Vincent Medical CenterPortland, United StatesTaking people
  • Kootenai Clinic Cancer Services - Post FallsPost Falls, United StatesTaking people
  • Illinois CancerCare-PrincetonPrinceton, United StatesTaking people
  • Duke Cancer Center RaleighRaleigh, United StatesTaking people
  • Corewell Health Reed City HospitalReed City, United StatesTaking people
  • Marshfield Medical Center-Rice LakeRice Lake, United StatesTaking people
  • UT Southwestern Clinical Center at Richardson/PlanoRichardson, United StatesTaking people
  • Bon Secours Richmond Community HospitalRichmond, United StatesTaking people
  • Bon Secours Saint Mary's HospitalRichmond, United StatesTaking people
  • VCU Massey Cancer Center at Stony PointRichmond, United StatesTaking people
  • VCU Massey Comprehensive Cancer CenterRichmond, United StatesTaking people
  • Presbyterian Rust Medical Center/Jorgensen Cancer CenterRio Rancho, United StatesTaking people
  • Kaiser Permanente-RiversideRiverside, United StatesTaking people
  • Rochester General HospitalRochester, United StatesTaking people
  • Unity Park Ridge CampusRochester, United StatesTaking people
  • University of RochesterRochester, United StatesTaking people
  • Levine Cancer Institute-Rock HillRock Hill, United StatesTaking people
  • UW Health Carbone Cancer Center RockfordRockford, United StatesTaking people
  • Highlands Oncology Group - RogersRogers, United StatesTaking people
  • Kaiser Permanente-RosevilleRoseville, United StatesTaking people
  • Kaiser Permanente Downtown CommonsSacramento, United StatesTaking people
  • Kaiser Permanente-South SacramentoSacramento, United StatesTaking people
  • University of California Davis Comprehensive Cancer CenterSacramento, United StatesTaking people
  • MyMichigan Medical Center SaginawSaginaw, United StatesTaking people
  • Oncology Hematology Associates of Saginaw Valley PCSaginaw, United StatesNo longer taking part
  • Coborn Cancer Center at Saint Cloud HospitalSaint Cloud, United StatesTaking people
  • Corewell Health Lakeland Hospitals - Marie Yeager Cancer CenterSaint Joseph, United StatesTaking people
  • Corewell Health Lakeland Hospitals - Saint Joseph HospitalSaint Joseph, United StatesTaking people
  • Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, United StatesTaking people
  • Regions HospitalSaint Paul, United StatesTaking people
  • United HospitalSaint Paul, United StatesTaking people
  • Sainte Genevieve County Memorial HospitalSainte Genevieve, United StatesTaking people
  • Salina Regional Health CenterSalina, United StatesTaking people
  • Huntsman Cancer Institute/University of UtahSalt Lake City, United StatesTaking people
  • Kaiser Permanente-San Diego ZionSan Diego, United StatesTaking people
  • Kaiser Permanente-San FranciscoSan Francisco, United StatesTaking people
  • Kaiser Permanente-Santa Teresa-San JoseSan Jose, United StatesTaking people
  • Kaiser Permanente San LeandroSan Leandro, United StatesTaking people
  • Kaiser Permanente-San MarcosSan Marcos, United StatesTaking people
  • Kaiser San Rafael-GallinasSan Rafael, United StatesTaking people
  • Kootenai Clinic Cancer Services - SandpointSandpoint, United StatesTaking people
  • Kaiser Permanente Medical Center - Santa ClaraSanta Clara, United StatesTaking people
  • Saint John's Cancer InstituteSanta Monica, United StatesTaking people
  • Kaiser Permanente-Santa RosaSanta Rosa, United StatesTaking people
  • Virginia Mason Medical CenterSeattle, United StatesTaking people
  • Prisma Health Cancer Institute - SenecaSeneca, United StatesTaking people
  • Sidney Kimmel Cancer Center Washington TownshipSewell, United StatesTaking people
  • Saint Vincent Hospital Cancer Center at SheboyganSheboygan, United StatesTaking people
  • Vince Lombardi Cancer Clinic-SheboyganSheboygan, United StatesTaking people
  • Atrium Health Cleveland/LCI-ClevelandShelby, United StatesTaking people
  • Memorial Hospital EastShiloh, United StatesTaking people
  • Sanford Cancer Center Oncology ClinicSioux Falls, United StatesTaking people
  • Sanford USD Medical Center - Sioux FallsSioux Falls, United StatesTaking people
  • Robert Wood Johnson University Hospital SomersetSomerville, United StatesTaking people
  • VCU Community Memorial Health CenterSouth Hill, United StatesTaking people
  • Kaiser Permanente-South San FranciscoSouth San Francisco, United StatesTaking people
  • Dana-Farber/Brigham and Women's Cancer Center at South ShoreSouth Weymouth, United StatesTaking people
  • Spartanburg Medical CenterSpartanburg, United StatesTaking people
  • Highlands Oncology GroupSpringdale, United StatesTaking people
  • Mercy Hospital SpringfieldSpringfield, United StatesTaking people
  • Southern Illinois University School of MedicineSpringfield, United StatesTaking people
  • Springfield ClinicSpringfield, United StatesTaking people
  • Springfield Memorial HospitalSpringfield, United StatesTaking people
  • Mercy Hospital Saint LouisSt Louis, United StatesTaking people
  • Mercy Hospital SouthSt Louis, United StatesTaking people
  • Missouri Baptist Medical CenterSt Louis, United StatesTaking people
  • Siteman Cancer Center at Christian HospitalSt Louis, United StatesTaking people
  • Siteman Cancer Center-South CountySt Louis, United StatesTaking people
  • Veteran's Affairs Medical Center - Saint LouisSt Louis, United StatesTaking people
  • Washington University School of MedicineSt Louis, United StatesTaking people
  • Smilow Cancer Hospital Care Center at Long RidgeStamford, United StatesTaking people
  • Marshfield Medical Center-River Region at Stevens PointStevens Point, United StatesTaking people
  • Stony Brook University Medical CenterStony Brook, United StatesTaking people
  • Saint Vincent Hospital Cancer Center at Sturgeon BaySturgeon Bay, United StatesTaking people
  • Missouri Baptist Sullivan HospitalSullivan, United StatesTaking people
  • Aurora Medical Center in SummitSummit, United StatesTaking people
  • ProMedica Flower HospitalSylvania, United StatesTaking people
  • MyMichigan Medical Center TawasTawas City, United StatesTaking people
  • Montefiore Medical Center-Einstein CampusThe Bronx, United StatesTaking people
  • Community Medical CenterToms River, United StatesTaking people
  • University of Kansas Health System Saint Francis CampusTopeka, United StatesTaking people
  • Smilow Cancer Hospital-Torrington Care CenterTorrington, United StatesTaking people
  • Munson Medical CenterTraverse City, United StatesTaking people
  • Smilow Cancer Hospital Care Center-TrumbullTrumbull, United StatesTaking people
  • Banner University Medical Center - TucsonTucson, United StatesTaking people
  • University of Arizona Cancer Center-North CampusTucson, United StatesTaking people
  • University of Arizona Cancer Center-Orange Grove CampusTucson, United StatesNo longer taking part
  • Oklahoma Cancer Specialists and Research Institute-TulsaTulsa, United StatesNo longer taking part
  • Vince Lombardi Cancer Clinic-Two RiversTwo Rivers, United StatesTaking people
  • SMC Center for Hematology Oncology UnionUnion, United StatesTaking people
  • Memorial Sloan Kettering NassauUniondale, United StatesTaking people
  • Carle Cancer CenterUrbana, United StatesTaking people
  • Kaiser Permanente-VallejoVallejo, United StatesTaking people
  • Kaiser Permanente-Walnut CreekWalnut Creek, United StatesTaking people
  • Northwestern Medicine Cancer Center WarrenvilleWarrenville, United StatesTaking people
  • Illinois CancerCare - WashingtonWashington, United StatesTaking people
  • George Washington University Medical CenterWashington D.C., United StatesTaking people
  • MedStar Georgetown University HospitalWashington D.C., United StatesTaking people
  • MedStar Washington Hospital CenterWashington D.C., United StatesTaking people
  • Sibley Memorial HospitalWashington D.C., United StatesTaking people
  • Smilow Cancer Hospital-Waterbury Care CenterWaterbury, United StatesTaking people
  • Smilow Cancer Hospital Care Center - WaterfordWaterford, United StatesTaking people
  • UI Health Care Mission Cancer and Blood - Waukee ClinicWaukee, United StatesTaking people
  • ProHealth Waukesha Memorial HospitalWaukesha, United StatesTaking people
  • UW Cancer Center at ProHealth CareWaukesha, United StatesTaking people
  • Aurora Cancer Care-Milwaukee WestWauwatosa, United StatesTaking people
  • Wilmot Cancer Institute at WebsterWebster, United StatesTaking people
  • Aurora West Allis Medical CenterWest Allis, United StatesTaking people
  • Henry Ford West Bloomfield HospitalWest Bloomfield, United StatesTaking people
  • Saint Mary's Oncology/Hematology Associates of West BranchWest Branch, United StatesNo longer taking part
  • University of Cincinnati Cancer Center-West ChesterWest Chester, United StatesTaking people
  • Reading HospitalWest Reading, United StatesTaking people
  • Smilow Cancer Hospital Care Center - WesterlyWesterly, United StatesTaking people
  • OhioHealth Westerville Medical Campus/Westerville Cancer CenterWesterville, United StatesNo longer taking part
  • Marshfield Medical Center - WestonWeston, United StatesTaking people
  • University of Kansas Hospital-Westwood Cancer CenterWestwood, United StatesTaking people
  • Asplundh Cancer PavilionWillow Grove, United StatesTaking people
  • Beth Israel Deaconess Medical Center/Winchester Center for Cancer CareWinchester, United StatesNo longer taking part
  • Wake Forest University Health SciencesWinston-Salem, United StatesTaking people
  • Kaiser Permanente-Woodland HillsWoodland Hills, United StatesTaking people
  • Henry Ford Wyandotte HospitalWyandotte, United StatesTaking people
  • University of Michigan Health - WestWyoming, United StatesTaking people
  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusYpsilanti, United StatesTaking people

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Trial details

Who runs it
National Cancer Institute (NCI)
Trial code
NCT05987241
Record updated
6 November 2026
Original description
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 full original descriptionShow less

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.

Inclusion: 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); 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.

ClinicalTrials.gov NCT05987241