Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer
Sponsor: National Cancer Institute (NCI) • ClinicalTrials.gov ID: NCT04628767
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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.
Interventions
-
Biopsy Procedure
(Procedure)
Undergo tissue biopsy
-
Biospecimen Collection
(Procedure)
Undergo blood sample collection
-
Cisplatin
(Drug)
Given IV
-
Computed Tomography
(Procedure)
Undergo CT
-
Doxorubicin Hydrochloride
(Drug)
Given Iv
-
Durvalumab
(Biological)
Given IV
-
Gemcitabine Hydrochloride
(Drug)
Given IV
-
Magnetic Resonance Imaging
(Procedure)
Undergo MRI
-
Methotrexate
(Drug)
Given IV
-
Pegfilgrastim
(Biological)
Given via injection
-
Therapeutic Conventional Surgery
(Procedure)
Undergo surgery
-
Vinblastine Sulfate
(Drug)
Given Iv
Eligibility criteria
Conditions
Locations
- 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 Maine Medical Center- Scarborough — Scarborough, 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
- Mercy Hospital Washington — Washington, Missouri, 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
- Cooperman 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
- UPMC Hillman Cancer Center — 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
- Vandalia Health/CAMC Institute for Academic Medicine — 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
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