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
Study Information
Alliance Study ID: A032103
NCT Study ID (ClinicalTrials.gov): NCT05987241
Alliance Committee: Genitourinary Cancer
Disease or Cancer Type: Genitourinary Cancers – Kidney / Bladder / Urothelial / Testicular
Alliance Study Chair: Matthew D Galsky
Status: RECRUITING
Study 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.
Related Publications
For publications related to this and other clinical trials, visit the Alliance Publications Application.
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Commack, New York 11725
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Harrison, New York 10604
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New York, New York 10011
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New York, New York 10029
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
NYP/Weill Cornell Medical Center
New York, New York 10065
United States
Rochester General Hospital
Rochester, New York 14621
United States
Unity Park Ridge Campus
Rochester, New York 14626
United States
University of Rochester
Rochester, New York 14642
United States
Stony Brook University Medical Center
Stony Brook, New York 11794
United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York 10461
United States
Memorial Sloan Kettering Nassau
Uniondale, New York 11553
United States
Wilmot Cancer Institute at Webster
Webster, New York 14580
United States
Atrium Health Stanly/LCI-Albemarle
Albemarle, North Carolina 28002
United States
Duke Cancer Center Cary
Cary, North Carolina 27518
United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina 28203
United States
Atrium Health Pineville/LCI-Pineville
Charlotte, North Carolina 28210
United States
Levine Cancer Institute-SouthPark
Charlotte, North Carolina 28211
United States
Atrium Health University City/LCI-University
Charlotte, North Carolina 28262
United States
Levine Cancer Institute-Ballantyne
Charlotte, North Carolina 28277
United States
Wake Forest University at Clemmons
Clemmons, North Carolina 27012
United States
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina 28025
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
Duke Cancer Center Southpoint
Durham, North Carolina 27713
United States
Levine Cancer Institute – Rutherford
Forest City, North Carolina 28043
United States
Levine Cancer Institute-Gaston
Gastonia, North Carolina 28054
United States
Levine Cancer Institute – Huntersville
Huntersville, North Carolina 28078
United States
Atrium Health Lincoln/LCI-Lincolnton
Lincolnton, North Carolina 28092
United States
Levine Cancer Institute – Union West
Matthews, North Carolina 28104
United States
Atrium Health Union/LCI-Union
Monroe, North Carolina 28112
United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina 28374
United States
Duke Cancer Center Raleigh
Raleigh, North Carolina 27609
United States
Atrium Health Cleveland/LCI-Cleveland
Shelby, North Carolina 28150
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
United States
Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
United States
Sanford Broadway Medical Center
Fargo, North Dakota 58122
United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
United States
OhioHealth O’Bleness Hospital
Athens, Ohio 45701
United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio 45219
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio 43214
United States
Riverside Methodist Hospital
Columbus, Ohio 43214
United States
Grant Medical Center
Columbus, Ohio 43215
United States
Doctors Hospital
Columbus, Ohio 43228
United States
Delaware Health Center-Grady Cancer Center
Delaware, Ohio 43015
United States
Grady Memorial Hospital
Delaware, Ohio 43015
United States
Columbus Oncology and Hematology Associates
Dublin, Ohio 43016
United States
Dublin Methodist Hospital
Dublin, Ohio 43016
United States
OhioHealth Mansfield Hospital
Mansfield, Ohio 44903
United States
OhioHealth Marion General Hospital
Marion, Ohio 43302
United States
OhioHealth Pickerington Methodist Hospital
Pickerington, Ohio 43147
United States
ProMedica Flower Hospital
Sylvania, Ohio 43560
United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio 45069
United States
OhioHealth Westerville Medical Campus/Westerville Cancer Center
Westerville, Ohio 43082
United States
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma 73505
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma 74146
United States
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon 97914
United States
Providence Willamette Falls Medical Center
Oregon City, Oregon 97045
United States
Providence Portland Medical Center
Portland, Oregon 97213
United States
Providence Saint Vincent Medical Center
Portland, Oregon 97225
United States
Oregon Health and Science University
Portland, Oregon 97239
United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania 18103
United States
UPMC Altoona
Altoona, Pennsylvania 16601
United States
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania 15009
United States
Lehigh Valley Hospital – Muhlenberg
Bethlehem, Pennsylvania 18017
United States
Pocono Medical Center
East Stroudsburg, Pennsylvania 18301
United States
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania 16505
United States
UPMC Cancer Centers – Arnold Palmer Pavilion
Greensburg, Pennsylvania 15601
United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania 17109
United States
Lancaster General Ann B Barshinger Cancer Institute
Lancaster, Pennsylvania 17601
United States
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania 17050
United States
UPMC Hillman Cancer Center – Monroeville
Monroeville, Pennsylvania 15146
United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania 19104
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United States
Jefferson Torresdale Hospital
Philadelphia, Pennsylvania 19114
United States
UPMC-Saint Margaret
Pittsburgh, Pennsylvania 15215
United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania 15232
United States
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania 15237
United States
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania 15243
United States
Reading Hospital
West Reading, Pennsylvania 19611
United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania 19090
United States
Smilow Cancer Hospital Care Center – Westerly
Westerly, Rhode Island 02891
United States
AnMed Health Cancer Center
Anderson, South Carolina 29621
United States
Prisma Health Cancer Institute – Spartanburg
Boiling Springs, South Carolina 29316
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
Prisma Health Cancer Institute – Easley
Easley, South Carolina 29640
United States
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina 29341
United States
Prisma Health Cancer Institute – Butternut
Greenville, South Carolina 29605
United States
Prisma Health Cancer Institute – Faris
Greenville, South Carolina 29605
United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina 29605
United States
Prisma Health Cancer Institute – Eastside
Greenville, South Carolina 29615
United States
Prisma Health Cancer Institute – Greer
Greer, South Carolina 29650
United States
Gibbs Cancer Center-Pelham
Greer, South Carolina 29651
United States
Levine Cancer Institute-Rock Hill
Rock Hill, South Carolina 29732
United States
Prisma Health Cancer Institute – Seneca
Seneca, South Carolina 29672
United States
Spartanburg Medical Center
Spartanburg, South Carolina 29303
United States
SMC Center for Hematology Oncology Union
Union, South Carolina 29379
United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
United States
Sanford USD Medical Center – Sioux Falls
Sioux Falls, South Dakota 57117-5134
United States
The West Clinic – Wolf River
Germantown, Tennessee 38138
United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
United States
UT Southwestern Simmons Cancer Center – RedBird
Dallas, Texas 75237
United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
United States
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas 76104
United States
Lyndon Baines Johnson General Hospital
Houston, Texas 77026-1967
United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas 77030
United States
Ben Taub General Hospital
Houston, Texas 77030
United States
Michael E DeBakey VA Medical Center
Houston, Texas 77030
United States
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas 75080
United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont 05602
United States
University of Vermont Medical Center
Burlington, Vermont 05401
United States
University of Vermont and State Agricultural College
Burlington, Vermont 05405
United States
University of Virginia Cancer Center
Charlottesville, Virginia 22908
United States
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia 23116
United States
Bon Secours Saint Francis Medical Center
Midlothian, Virginia 23114
United States
Bon Secours Richmond Community Hospital
Richmond, Virginia 23223
United States
Bon Secours Saint Mary’s Hospital
Richmond, Virginia 23226
United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia 23235
United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia 23298
United States
VCU Community Memorial Health Center
South Hill, Virginia 23970
United States
Virginia Mason Medical Center
Seattle, Washington 98101
United States
West Virginia University Charleston Division
Charleston, West Virginia 25304
United States
West Virginia University Healthcare
Morgantown, West Virginia 26506
United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin 54911
United States
Aurora Saint Luke’s South Shore
Cudahy, Wisconsin 53110
United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin 53024
United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin 54301
United States
Saint Vincent Hospital Cancer Center at Saint Mary’s
Green Bay, Wisconsin 54303
United States
Aurora BayCare Medical Center
Green Bay, Wisconsin 54311
United States
University of Wisconsin Carbone Cancer Center – Eastpark Medical Center
Madison, Wisconsin 53718
United States
University of Wisconsin Carbone Cancer Center – University Hospital
Madison, Wisconsin 53792
United States
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin 54143
United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
United States
Aurora Saint Luke’s Medical Center
Milwaukee, Wisconsin 53215
United States
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin 53233
United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin 53149
United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin 53066
United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin 54154
United States
Vince Lombardi Cancer Clinic – Oshkosh
Oshkosh, Wisconsin 54904
United States
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin 53081
United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin 53081
United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin 54482
United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin 54235-1495
United States
Aurora Medical Center in Summit
Summit, Wisconsin 53066
United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin 54241
United States
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin 53188
United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin 53188
United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin 53226
United States
Aurora West Allis Medical Center
West Allis, Wisconsin 53227
United States
Marshfield Medical Center – Weston
Weston, Wisconsin 54476
United States
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta T2N 5G2
Canada
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
Canada
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia V5Z 4E6
Canada
Waterloo Regional Health Network
Kitchener, Ontario N2G 1G3
Canada
London Regional Cancer Program
London, Ontario N6A 4L6
Canada
Ottawa Hospital and Cancer Center-General Campus
Ottawa, Ontario K1H 8L6
Canada
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario M4N 3M5
Canada
University Health Network-Princess Margaret Hospital
Toronto, Ontario M5G 2M9
Canada
Data Sources & Contacts
Full trial details
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