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Brief Title: Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer
Official Title: A Phase II/III Trial of Durvalumab and Chemotherapy for Patients With High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy
Study ID: NCT04628767
Brief 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.
Detailed Description: PRIMARY OBJECTIVES: I. To compare event-free survival (EFS) between patients with upper tract urothelial cancer (UTUC) randomized to neoadjuvant accelerated methotrexate, vinblastine, adriamycin, cisplatin (aMVAC) alone or in combination with durvalumab. (Cisplatin eligible patients \[Arms A and B\]) II. Evaluation of pathologic complete response at radical nephroureterectomy (RNU) (pathologic complete response \[pCR\], pT0N0/ Nx). (Cisplatin ineligible patients \[Arm C\]). SECONDARY OBJECTIVES: I. To assess pathologic complete response (pCR) at surgery. (Cisplatin eligible cohort) II. Event-free survival (EFS) will be evaluated for the cisplatin ineligible cohort as a secondary endpoint. (Cisplatin ineligible cohort) III. Overall survival in all, and by post chemotherapy response (ypCR, yp =\< T1N0, yp \>= T2Nany). (All patients) IV. To evaluate disease-free survival (DFS) in each arm of the trial separately. (All patients) V. To evaluate cancer-specific survival of patients in each arm of the trial separately. (All patients) VI. To evaluate renal function outcomes following systemic treatment and following surgery (\[RNU) in each arm of the trial separately. (All patients) VII. To evaluate safety and tolerability of neoadjuvant aMVAC alone or in combination with durvalumab prior to RNU. (All patients) OUTLINE: Patients eligible for cisplatin are randomized to Arms A or B. Patients ineligible for cisplatin are assigned to Arm C. ARM A: Patients receive durvalumab intravenously (IV) over 60 minutes on day 1 of chemotherapy cycles 1 and 3. Patients also receive methotrexate IV over 2-3 minutes, vinblastine sulfate IV, doxorubicin IV, cisplatin IV over at least 2 hours on day 1. Treatments repeat every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery. ARM B: Patients also receive methotrexate IV over 2-3 minutes, vinblastine sulfate IV, doxorubicin IV, cisplatin IV over at least 2 hours on day 1. Treatments repeat every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment, patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery. ARM C: Patients receive durvalumab IV over 60 minutes on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 21- 60 days after completion of systemic treatment patients with continued lack of radiographic presence of metastatic or unresectable disease undergo surgery. Patients also undergo tissue biopsy and blood sample collection on study, and computed tomography (CT) or magnetic resonance imaging (MRI) throughout the trial. After completion of study treatment, patients are followed up within 30 days and then every 3-6 months for up to 5 years from study entry.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
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
California Pacific Medical Center-Pacific Campus, San Francisco, California, United States
Palo Alto Medical Foundation-Santa Cruz, Santa Cruz, 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
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
Medical Center of the Rockies, Loveland, Colorado, United States
MedStar Washington Hospital Center, Washington, District of Columbia, United States
Sibley Memorial Hospital, Washington, 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
Saint Anthony's Health, 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
Good Samaritan Regional Health Center, 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
Memorial Medical Center, 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
East Jefferson General Hospital, Metairie, Louisiana, United States
LSU Healthcare Network / Metairie Multi-Specialty Clinic, Metairie, Louisiana, United States
Harold Alfond Center for Cancer Care, Augusta, Maine, United States
MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford, Biddeford, Maine, United States
MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford, Sanford, Maine, United States
Maine Medical Partners - 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
Saint Joseph Mercy Chelsea, 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
Genesee Cancer and Blood Disease Treatment Center, Flint, Michigan, United States
Genesee Hematology Oncology PC, Flint, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
Hope Cancer Clinic, Livonia, Michigan, United States
Trinity Health Saint Mary Mercy Livonia Hospital, Livonia, Michigan, United States
Great Lakes Cancer Management Specialists-Macomb Medical Campus, 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
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
Saint Louis Cancer and Breast Institute-Ballwin, Ballwin, Missouri, United States
Central Care Cancer Center - Bolivar, Bolivar, Missouri, United States
Saint Francis Medical Center, Cape Girardeau, Missouri, United States
Southeast Cancer 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
Delbert Day Cancer Institute at PCRMC, Rolla, Missouri, United States
Mercy Clinic-Rolla-Cancer and Hematology, Rolla, Missouri, United States
Heartland Regional Medical Center, Saint Joseph, Missouri, United States
Saint Louis Cancer and Breast Institute-South City, Saint Louis, Missouri, United States
Mercy Hospital South, Saint Louis, Missouri, United States
Missouri Baptist Medical Center, Saint Louis, Missouri, United States
Mercy Hospital Saint Louis, Saint Louis, 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
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
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
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
FHCC South Lake Union, Seattle, Washington, United States
Fred Hutchinson Cancer Center, Seattle, Washington, United States
University of Washington Medical Center - Montlake, Seattle, Washington, 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 Clinic-Minocqua Center, 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
Name: Jean H Hoffman-Censits
Affiliation: ECOG-ACRIN Cancer Research Group
Role: PRINCIPAL_INVESTIGATOR