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Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer
Sponsor: National Cancer Institute (NCI)
Summary
This phase II/III trial compares the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin, cisplatin, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab in combination with chemotherapy before surgery may enhance the shrinking of the tumor compared to chemotherapy alone.
Official title: A Phase II/III Trial of Durvalumab and Chemotherapy for Patients With High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
249
Start Date
2021-11-12
Completion Date
2027-09-30
Last Updated
2026-04-09
Healthy Volunteers
No
Interventions
Biopsy Procedure
Undergo tissue biopsy
Biospecimen Collection
Undergo blood sample collection
Cisplatin
Given IV
Computed Tomography
Undergo CT
Doxorubicin Hydrochloride
Given Iv
Durvalumab
Given IV
Gemcitabine Hydrochloride
Given IV
Magnetic Resonance Imaging
Undergo MRI
Methotrexate
Given IV
Pegfilgrastim
Given via injection
Therapeutic Conventional Surgery
Undergo surgery
Vinblastine Sulfate
Given Iv
Locations (258)
Kingman Regional Medical Center
Kingman, Arizona, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Sutter Auburn Faith Hospital
Auburn, California, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Palo Alto Medical Foundation-Fremont
Fremont, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Memorial Medical Center
Modesto, California, United States
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States
Sutter Roseville Medical Center
Roseville, California, United States
Sutter Medical Center Sacramento
Sacramento, California, United States
UC San Diego Medical Center - Hillcrest
San Diego, California, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California, United States
Sutter Pacific Medical Foundation
Santa Rosa, California, United States
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
UCHealth - Cherry Creek
Denver, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, United States
UCHealth Greeley Hospital
Greeley, Colorado, United States
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, United States
UCHealth Lone Tree Health Center
Lone Tree, Colorado, United States
Medical Center of the Rockies
Loveland, Colorado, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Emory Decatur Hospital
Decatur, Georgia, United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, United States
OSF Saint Anthony's Health Center
Alton, Illinois, United States
Advocate Good Shepherd Hospital
Barrington, Illinois, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States
Loyola Center for Health at Burr Ridge
Burr Ridge, Illinois, United States
Illinois CancerCare-Canton
Canton, Illinois, United States
Memorial Hospital of Carbondale
Carbondale, Illinois, United States
SIH Cancer Institute
Carterville, Illinois, United States
Illinois CancerCare-Carthage
Carthage, Illinois, United States
Centralia Oncology Clinic
Centralia, Illinois, United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, United States
Carle at The Riverfront
Danville, Illinois, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Illinois CancerCare-Dixon
Dixon, Illinois, United States
Advocate Good Samaritan Hospital
Downers Grove, Illinois, United States
Carle Physician Group-Effingham
Effingham, Illinois, United States
Crossroads Cancer Center
Effingham, Illinois, United States
Advocate Sherman Hospital
Elgin, Illinois, United States
Illinois CancerCare-Eureka
Eureka, Illinois, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, United States
Advocate South Suburban Hospital
Hazel Crest, Illinois, United States
Loyola Medicine Homer Glen
Homer Glen, Illinois, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States
AMG Libertyville - Oncology
Libertyville, Illinois, United States
Illinois CancerCare-Macomb
Macomb, Illinois, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Melrose Park, Illinois, United States
SSM Health Good Samaritan
Mount Vernon, Illinois, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Illinois CancerCare-Pekin
Pekin, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Illinois CancerCare-Peru
Peru, Illinois, United States
Valley Radiation Oncology
Peru, Illinois, United States
Illinois CancerCare-Princeton
Princeton, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
Springfield Memorial Hospital
Springfield, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Illinois CancerCare - Washington
Washington, Illinois, United States
Reid Health
Richmond, Indiana, United States
Mary Greeley Medical Center
Ames, Iowa, United States
McFarland Clinic - Ames
Ames, Iowa, United States
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, United States
McFarland Clinic - Boone
Boone, Iowa, United States
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
McFarland Clinic - Jefferson
Jefferson, Iowa, United States
McFarland Clinic - Marshalltown
Marshalltown, Iowa, United States
Central Care Cancer Center - Garden City
Garden City, Kansas, United States
Central Care Cancer Center - Great Bend
Great Bend, Kansas, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Mary Bird Perkins Cancer Center - Metairie
Metairie, Louisiana, United States
East Jefferson General Hospital
Metairie, Louisiana, United States
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, United States
MaineHealth Maine Medical Center - Biddeford
Biddeford, Maine, United States
MaineHealth Cancer Care and IV Therapy - Sanford
Sanford, Maine, United States
MaineHealth Cancer Care Center of York County
Sanford, Maine, United States
MaineHealth Cancer Care and IV Therapy - South Portland
South Portland, Maine, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, United States
Trinity Health Medical Center - Brighton
Brighton, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, United States
Trinity Health Medical Center - Canton
Canton, Michigan, United States
Chelsea Hospital
Chelsea, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, United States
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, United States
Newland Medical Associates-Clarkston
Clarkston, Michigan, United States
Cancer Hematology Centers - Flint
Flint, Michigan, United States
Genesee Hematology Oncology PC
Flint, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Hope Cancer Clinic
Livonia, Michigan, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, United States
Henry Ford Saint John Hospital - Macomb Medical
Macomb, Michigan, United States
Michigan Healthcare Professionals Pontiac
Pontiac, Michigan, United States
Newland Medical Associates-Pontiac
Pontiac, Michigan, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, United States
MyMichigan Medical Center Saginaw
Saginaw, Michigan, United States
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, United States
MyMichigan Medical Center Tawas
Tawas City, Michigan, United States
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan, United States
Huron Gastroenterology PC
Ypsilanti, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Minnesota Oncology - Burnsville
Burnsville, Minnesota, United States
Cambridge Medical Center
Cambridge, Minnesota, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Unity Hospital
Fridley, Minnesota, United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Health Partners Inc
Minneapolis, Minnesota, United States
Monticello Cancer Center
Monticello, Minnesota, United States
New Ulm Medical Center
New Ulm, Minnesota, United States
Fairview Northland Medical Center
Princeton, Minnesota, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States
Lakeview Hospital
Stillwater, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Rice Memorial Hospital
Willmar, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, United States
Fairview Lakes Medical Center
Wyoming, Minnesota, United States
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, United States
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Parkland Health Center - Farmington
Farmington, Missouri, United States
MU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri, United States
Freeman Health System
Joplin, Missouri, United States
Mercy Hospital Joplin
Joplin, Missouri, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States
Phelps Health Delbert Day Cancer Institute
Rolla, Missouri, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Mercy Infusion Center - Chippewa
St Louis, Missouri, United States
Mercy Hospital South
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, United States
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, United States
Mercy Hospital Washington
Washington, Missouri, United States
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Community Medical Center
Toms River, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, United States
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, United States
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, United States
Miami Valley Hospital South
Centerville, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Premier Blood and Cancer Center
Dayton, Ohio, United States
Dayton Physician LLC - Englewood
Dayton, Ohio, United States
Miami Valley Hospital North
Dayton, Ohio, United States
Armes Family Cancer Center
Findlay, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States
Dayton Physicians LLC-Atrium
Franklin, Ohio, United States
Miami Valley Cancer Care and Infusion
Greenville, Ohio, United States
Greater Dayton Cancer Center
Kettering, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Springfield Regional Cancer Center
Springfield, Ohio, United States
ProMedica Flower Hospital
Sylvania, Ohio, United States
Upper Valley Medical Center
Troy, Ohio, United States
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, United States
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, United States
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, United States
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, United States
UPMC Cancer Center-Washington
Washington, Pennsylvania, United States
Reading Hospital
West Reading, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Parkland Memorial Hospital
Dallas, Texas, United States
UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas, United States
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
University of Washington Medical Center - Montlake
Seattle, Washington, United States
West Virginia University Charleston Division
Charleston, West Virginia, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, United States
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, United States
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States
Aurora Cancer Care-Racine
Racine, Wisconsin, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, United States
Aurora Medical Center in Summit
Summit, Wisconsin, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, United States
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, United States
ThedaCare Cancer Care - Waupaca
Waupaca, Wisconsin, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, United States