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Spots Global Cancer Trial Database for Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

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

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

Contact Details

Name: Jean H Hoffman-Censits

Affiliation: ECOG-ACRIN Cancer Research Group

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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