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Sammenligning af standardbehandling med en tripletkombination af målrettede immunterapeutiske midler

21. oktober 2026 opdateret af: National Cancer Institute (NCI)

Et randomiseret fase II-forsøg med tripletterapi (en PD-L1-hæmmer Durvalumab (MEDI4736) i kombination med Olaparib og Cediranib) sammenlignet med Olaparib og Cediranib eller Durvalumab (MEDI4736) og Cediranib eller Standard of Care-tilbagevendende kemoterapi med epitheli-repideli hos kvinder Kræft i æggestokkene, primær peritoneal eller æggelederkræft, der tidligere har modtaget Bevacizumab

This phase II trial studies the possible benefits of treatment with different combinations of the drugs durvalumab, olaparib and cediranib vs. the usual treatment in patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back after a period of improvement with platinum therapy (recurrent platinum resistant). Usual treatment is the type of treatment most patients with this condition receive if they are not part of a clinical study. Combination therapies studied in this trial include MEDI4736 (durvalumab) plus olaparib and cediranib, durvalumab and cediranib, or olaparib and cediranib. Monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumors cells to grow and spread. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Cediranib may stop the growth of tumor cells by blocking VEGF (an enzyme). needed for cell growth. Giving different combinations of durvalumab, olaparib and cediranib may work better in increasing the duration of time that the cancer does not progress compared to the usual treatment.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

PRIMARY OBJECTIVE:

I. To assess the efficacy of the combinations durvalumab (MEDI4736) plus olaparib and cediranib, durvalumab (MEDI4736) plus cediranib, or olaparib and cediranib, as measured by progression-free survival (PFS), as compared to physician's choice standard of care chemotherapy, in patients with recurrent platinum-resistant ovarian, primary peritoneal or fallopian tube cancer who had prior bevacizumab.

SECONDARY OBJECTIVES:

I. To assess the efficacy of the combinations durvalumab (MEDI4736) plus olaparib and cediranib, durvalumab (MEDI4736) plus cediranib, or olaparib and cediranib, as measured by overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as compared to physician's choice standard of care chemotherapy, in patients with recurrent platinum-resistant ovarian, primary peritoneal or fallopian tube cancer who had prior bevacizumab.

II. To assess the efficacy of the combinations durvalumab (MEDI4736) plus olaparib and cediranib, durvalumab (MEDI4736) plus cediranib, or olaparib and cediranib, as measured by overall survival (OS), as compared to physician's choice standard of care chemotherapy, in patients with recurrent platinum-resistant ovarian, primary peritoneal or fallopian tube cancer who had prior bevacizumab.

OUTLINE: Patients are randomized to 1 of 4 arms.

ARM I: Patients receive paclitaxel intravenously (IV) over 60 minutes on days 1, 8, and 15, or pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1, or topotecan hydrochloride IV over 30 minutes on days 1, 8 and 15 or days 1-5 per the discretion of the treating physician. Cycles repeat every 21 or 28 days in the absence of disease progression or unacceptable toxicity. Patients may undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) during screening and as clinically indicated on study. Patients also undergo collection of blood and computed tomography (CT) with contrast during screening, and CT or magnetic resonance imaging (MRI) scans throughout the trial.

ARM II: Patients receive durvalumab IV over 60 minutes on day 1, cediranib maleate orally (PO) once daily (QD) Monday through Friday, and olaparib PO twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo collection of blood and CT with contrast during screening, and CT or MRI scans throughout the trial.

ARM III: Patients receive durvalumab IV over 60 minutes on day 1 and cediranib maleate PO QD Monday through Friday. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo collection of blood and CT with contrast during screening, and CT or MRI scans throughout the trial.

ARM IV: Patients receive cediranib maleate PO QD on days 1-28 and olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo collection of blood and CT with contrast during screening, and CT or MRI scans throughout the trial.

After completion of study treatment, patients are followed up periodically for up to 5 years.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

120

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alaska
      • Anchorage, Alaska, Forenede Stater, 98508
        • Anchorage Associates in Radiation Medicine
      • Anchorage, Alaska, Forenede Stater, 99508
        • Alaska Breast Care and Surgery LLC
      • Anchorage, Alaska, Forenede Stater, 99508
        • Alaska Oncology and Hematology LLC
      • Anchorage, Alaska, Forenede Stater, 99508
        • Alaska Women's Cancer Care
      • Anchorage, Alaska, Forenede Stater, 99508
        • Anchorage Oncology Centre
      • Anchorage, Alaska, Forenede Stater, 99508
        • Katmai Oncology Group
      • Anchorage, Alaska, Forenede Stater, 99508
        • Providence Alaska Medical Center
      • Anchorage, Alaska, Forenede Stater, 99504
        • Anchorage Radiation Therapy Center
      • Fairbanks, Alaska, Forenede Stater, 99701
        • Fairbanks Memorial Hospital
    • Arizona
      • Goodyear, Arizona, Forenede Stater, 85338
        • CTCA at Western Regional Medical Center
      • Phoenix, Arizona, Forenede Stater, 85004
        • Cancer Center at Saint Joseph's
    • Arkansas
      • Fort Smith, Arkansas, Forenede Stater, 72903
        • Mercy Hospital Fort Smith
      • Hot Springs, Arkansas, Forenede Stater, 71913
        • CHI Saint Vincent Cancer Center Hot Springs
      • Little Rock, Arkansas, Forenede Stater, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Arroyo Grande, California, Forenede Stater, 93420
        • Mission Hope Medical Oncology - Arroyo Grande
      • Auburn, California, Forenede Stater, 95602
        • Sutter Auburn Faith Hospital
      • Auburn, California, Forenede Stater, 95603
        • Sutter Cancer Centers Radiation Oncology Services-Auburn
      • Berkeley, California, Forenede Stater, 94704
        • Alta Bates Summit Medical Center-Herrick Campus
      • Burbank, California, Forenede Stater, 91505
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • Cameron Park, California, Forenede Stater, 95682
        • Sutter Cancer Centers Radiation Oncology Services-Cameron Park
      • Castro Valley, California, Forenede Stater, 94546
        • Eden Hospital Medical Center
      • Concord, California, Forenede Stater, 94520
        • John Muir Medical Center-Concord
      • Davis, California, Forenede Stater, 95616
        • Sutter Davis Hospital
      • Duarte, California, Forenede Stater, 91010
        • City of Hope Comprehensive Cancer Center
      • Fremont, California, Forenede Stater, 94538
        • Palo Alto Medical Foundation-Fremont
      • Lancaster, California, Forenede Stater, 93534
        • City of Hope Antelope Valley
      • Los Angeles, California, Forenede Stater, 90033
        • USC / Norris Comprehensive Cancer Center
      • Los Angeles, California, Forenede Stater, 90033
        • Los Angeles General Medical Center
      • Modesto, California, Forenede Stater, 95355
        • Memorial Medical Center
      • Mountain View, California, Forenede Stater, 94040
        • Palo Alto Medical Foundation-Camino Division
      • Mountain View, California, Forenede Stater, 94040
        • Palo Alto Medical Foundation-Gynecologic Oncology
      • Palo Alto, California, Forenede Stater, 94301
        • Palo Alto Medical Foundation Health Care
      • Roseville, California, Forenede Stater, 95661
        • Sutter Cancer Centers Radiation Oncology Services-Roseville
      • Roseville, California, Forenede Stater, 95661
        • Sutter Roseville Medical Center
      • Sacramento, California, Forenede Stater, 95816
        • Sutter Medical Center Sacramento
      • San Francisco, California, Forenede Stater, 94115
        • California Pacific Medical Center-Pacific Campus
      • San Luis Obispo, California, Forenede Stater, 93401
        • Pacific Central Coast Health Center-San Luis Obispo
      • Santa Cruz, California, Forenede Stater, 95065
        • Palo Alto Medical Foundation-Santa Cruz
      • Santa Maria, California, Forenede Stater, 93444
        • Mission Hope Medical Oncology - Santa Maria
      • Santa Rosa, California, Forenede Stater, 95403
        • Sutter Pacific Medical Foundation
      • South Pasadena, California, Forenede Stater, 91030
        • City of Hope South Pasadena
      • Sunnyvale, California, Forenede Stater, 94086
        • Palo Alto Medical Foundation-Sunnyvale
      • Upland, California, Forenede Stater, 91786
        • City of Hope Upland
      • Vallejo, California, Forenede Stater, 94589
        • Sutter Solano Medical Center/Cancer Center
      • Walnut Creek, California, Forenede Stater, 94598
        • John Muir Medical Center-Walnut Creek
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80012
        • Rocky Mountain Cancer Centers-Aurora
      • Boulder, Colorado, Forenede Stater, 80304
        • Rocky Mountain Cancer Centers-Boulder
      • Centennial, Colorado, Forenede Stater, 80112
        • Rocky Mountain Cancer Centers - Centennial
      • Colorado Springs, Colorado, Forenede Stater, 80907
        • Penrose-Saint Francis Healthcare
      • Colorado Springs, Colorado, Forenede Stater, 80907
        • Rocky Mountain Cancer Centers-Penrose
      • Denver, Colorado, Forenede Stater, 80210
        • AdventHealth Porter
      • Durango, Colorado, Forenede Stater, 81301
        • Mercy Medical Center
      • Durango, Colorado, Forenede Stater, 81301
        • CommonSpirit Cancer Center Mercy
      • Lakewood, Colorado, Forenede Stater, 80228
        • CommonSpirit Saint Anthony Hospital Cancer Center
      • Littleton, Colorado, Forenede Stater, 80120
        • Rocky Mountain Cancer Centers-Littleton
      • Littleton, Colorado, Forenede Stater, 80122
        • AdventHealth Littleton
      • Lone Tree, Colorado, Forenede Stater, 80124
        • Rocky Mountain Cancer Centers-Sky Ridge
      • Longmont, Colorado, Forenede Stater, 80501
        • Longmont United Hospital
      • Longmont, Colorado, Forenede Stater, 80501
        • Rocky Mountain Cancer Centers-Longmont
      • Loveland, Colorado, Forenede Stater, 80539
        • Banner North Colorado Medical Center - Loveland Campus
      • Parker, Colorado, Forenede Stater, 80138
        • AdventHealth Parker
      • Pueblo, Colorado, Forenede Stater, 81004
        • Saint Mary Corwin Medical Center
    • Connecticut
      • Danbury, Connecticut, Forenede Stater, 06810
        • Danbury Hospital
      • Norwalk, Connecticut, Forenede Stater, 06856
        • Norwalk Hospital
    • Florida
      • Pensacola, Florida, Forenede Stater, 32504
        • Sacred Heart Hospital
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30342
        • Northside Hospital
      • Newnan, Georgia, Forenede Stater, 30265
        • CTCA at Southeastern Regional Medical Center
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96813
        • Queen's Medical Center
      • Honolulu, Hawaii, Forenede Stater, 96826
        • Kapiolani Medical Center for Women and Children
    • Idaho
      • Boise, Idaho, Forenede Stater, 83706
        • Saint Alphonsus Cancer Care Center-Boise
      • Boise, Idaho, Forenede Stater, 83712
        • Saint Luke's Cancer Institute - Boise
      • Caldwell, Idaho, Forenede Stater, 83605
        • Saint Alphonsus Cancer Care Center-Caldwell
      • Coeur d'Alene, Idaho, Forenede Stater, 83814
        • Kootenai Health - Coeur d'Alene
      • Emmett, Idaho, Forenede Stater, 83617
        • Walter Knox Memorial Hospital
      • Fruitland, Idaho, Forenede Stater, 83619
        • Saint Luke's Cancer Institute - Fruitland
      • Meridian, Idaho, Forenede Stater, 83642
        • Idaho Urologic Institute-Meridian
      • Meridian, Idaho, Forenede Stater, 83642
        • Saint Luke's Cancer Institute - Meridian
      • Nampa, Idaho, Forenede Stater, 83687
        • Saint Alphonsus Cancer Care Center-Nampa
      • Nampa, Idaho, Forenede Stater, 83687
        • Saint Luke's Cancer Institute - Nampa
      • Post Falls, Idaho, Forenede Stater, 83854
        • Kootenai Clinic Cancer Services - Post Falls
      • Sandpoint, Idaho, Forenede Stater, 83864
        • Kootenai Clinic Cancer Services - Sandpoint
      • Twin Falls, Idaho, Forenede Stater, 83301
        • Saint Luke's Cancer Institute - Twin Falls
    • Illinois
      • Alton, Illinois, Forenede Stater, 62002
        • OSF Saint Anthony's Health Center
      • Aurora, Illinois, Forenede Stater, 60504
        • Rush-Copley Medical Center
      • Bloomington, Illinois, Forenede Stater, 61704
        • Illinois CancerCare-Bloomington
      • Canton, Illinois, Forenede Stater, 61520
        • Illinois CancerCare-Canton
      • Carbondale, Illinois, Forenede Stater, 62902
        • Memorial Hospital of Carbondale
      • Carterville, Illinois, Forenede Stater, 62918
        • SIH Cancer Institute
      • Carthage, Illinois, Forenede Stater, 62321
        • Illinois CancerCare-Carthage
      • Centralia, Illinois, Forenede Stater, 62801
        • Centralia Oncology Clinic
      • Chicago, Illinois, Forenede Stater, 60637
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, Forenede Stater, 60612
        • John H Stroger Jr Hospital of Cook County
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush MD Anderson Cancer Center
      • Danville, Illinois, Forenede Stater, 61832
        • Carle at The Riverfront
      • Decatur, Illinois, Forenede Stater, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, Forenede Stater, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Dixon, Illinois, Forenede Stater, 61021
        • Illinois CancerCare-Dixon
      • Effingham, Illinois, Forenede Stater, 62401
        • Crossroads Cancer Center
      • Effingham, Illinois, Forenede Stater, 62401
        • Carle Physician Group-Effingham
      • Eureka, Illinois, Forenede Stater, 61530
        • Illinois CancerCare-Eureka
      • Evanston, Illinois, Forenede Stater, 60201
        • NorthShore University HealthSystem-Evanston Hospital
      • Galesburg, Illinois, Forenede Stater, 61401
        • Western Illinois Cancer Treatment Center
      • Galesburg, Illinois, Forenede Stater, 61401
        • Illinois CancerCare-Galesburg
      • Geneva, Illinois, Forenede Stater, 60134
        • Northwestern Medicine Cancer Center Delnor
      • Glenview, Illinois, Forenede Stater, 60026
        • NorthShore University HealthSystem-Glenbrook Hospital
      • Harvey, Illinois, Forenede Stater, 60426
        • Ingalls Memorial Hospital
      • Highland Park, Illinois, Forenede Stater, 60035
        • NorthShore University HealthSystem-Highland Park Hospital
      • Hinsdale, Illinois, Forenede Stater, 60521
        • Sudarshan K Sharma MD Limited-Gynecologic Oncology
      • Kewanee, Illinois, Forenede Stater, 61443
        • Illinois CancerCare-Kewanee Clinic
      • Macomb, Illinois, Forenede Stater, 61455
        • Illinois CancerCare-Macomb
      • Mattoon, Illinois, Forenede Stater, 61938
        • Carle Physician Group-Mattoon/Charleston
      • Mount Vernon, Illinois, Forenede Stater, 62864
        • SSM Health Good Samaritan
      • New Lenox, Illinois, Forenede Stater, 60451
        • UC Comprehensive Cancer Center at Silver Cross
      • O'Fallon, Illinois, Forenede Stater, 62269
        • Cancer Care Center of O'Fallon
      • Orland Park, Illinois, Forenede Stater, 60462
        • University of Chicago Medicine-Orland Park
      • Ottawa, Illinois, Forenede Stater, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Pekin, Illinois, Forenede Stater, 61554
        • Illinois CancerCare-Pekin
      • Peoria, Illinois, Forenede Stater, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, Forenede Stater, 61615
        • Illinois CancerCare-Peoria
      • Peru, Illinois, Forenede Stater, 61354
        • Illinois CancerCare-Peru
      • Peru, Illinois, Forenede Stater, 61354
        • Valley Radiation Oncology
      • Princeton, Illinois, Forenede Stater, 61356
        • Illinois CancerCare-Princeton
      • Springfield, Illinois, Forenede Stater, 62702
        • Southern Illinois University School of Medicine
      • Springfield, Illinois, Forenede Stater, 62702
        • Springfield Clinic
      • Springfield, Illinois, Forenede Stater, 62781
        • Springfield Memorial Hospital
      • Urbana, Illinois, Forenede Stater, 61801
        • Carle Cancer Center
      • Urbana, Illinois, Forenede Stater, 61801
        • The Carle Foundation Hospital
      • Warrenville, Illinois, Forenede Stater, 60555
        • Northwestern Medicine Cancer Center Warrenville
      • Washington, Illinois, Forenede Stater, 61571
        • Illinois CancerCare - Washington
      • Yorkville, Illinois, Forenede Stater, 60560
        • Rush-Copley Healthcare Center
      • Zion, Illinois, Forenede Stater, 60099
        • Midwestern Regional Medical Center
    • Indiana
      • South Bend, Indiana, Forenede Stater, 46601
        • Memorial Hospital of South Bend
    • Iowa
      • Ames, Iowa, Forenede Stater, 50010
        • Mary Greeley Medical Center
      • Ames, Iowa, Forenede Stater, 50010
        • McFarland Clinic - Ames
      • Boone, Iowa, Forenede Stater, 50036
        • McFarland Clinic - Boone
      • Cedar Rapids, Iowa, Forenede Stater, 52403
        • Mercy Hospital
      • Cedar Rapids, Iowa, Forenede Stater, 52403
        • Oncology Associates at Mercy Medical Center
      • Clive, Iowa, Forenede Stater, 50325
        • Mercy Cancer Center-West Lakes
      • Clive, Iowa, Forenede Stater, 50325
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
      • Council Bluffs, Iowa, Forenede Stater, 51503
        • Alegent Health Mercy Hospital
      • Creston, Iowa, Forenede Stater, 50801
        • Greater Regional Medical Center
      • Des Moines, Iowa, Forenede Stater, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, Forenede Stater, 50314
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
      • Fort Dodge, Iowa, Forenede Stater, 50501
        • McFarland Clinic - Trinity Cancer Center
      • Iowa City, Iowa, Forenede Stater, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
      • Jefferson, Iowa, Forenede Stater, 50129
        • McFarland Clinic - Jefferson
      • Marshalltown, Iowa, Forenede Stater, 50158
        • McFarland Clinic - Marshalltown
      • West Des Moines, Iowa, Forenede Stater, 50266
        • Mercy Medical Center-West Lakes
    • Kansas
      • Garden City, Kansas, Forenede Stater, 67846
        • Central Care Cancer Center - Garden City
      • Great Bend, Kansas, Forenede Stater, 67530
        • Central Care Cancer Center - Great Bend
    • Kentucky
      • Bardstown, Kentucky, Forenede Stater, 40004
        • CommonSpirit Saint Joseph Hospital - Bardstown
      • Corbin, Kentucky, Forenede Stater, 40701
        • Commonwealth Cancer Center-Corbin
      • Lexington, Kentucky, Forenede Stater, 40504
        • Saint Joseph Radiation Oncology Resource Center
      • Lexington, Kentucky, Forenede Stater, 40509
        • CommonSpirit Saint Joseph Medical Center - East Lexington
      • London, Kentucky, Forenede Stater, 40741
        • CommonSpirit Saint Joseph Hospital London
      • Louisville, Kentucky, Forenede Stater, 40202
        • Jewish Hospital
      • Louisville, Kentucky, Forenede Stater, 40245
        • UofL Health Medical Center Northeast
      • Louisville, Kentucky, Forenede Stater, 40215
        • Saints Mary and Elizabeth Hospital
      • Shepherdsville, Kentucky, Forenede Stater, 40165
        • Jewish Hospital Medical Center South
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70817
        • Our Lady of the Lake Medical Oncology
    • Maine
      • Augusta, Maine, Forenede Stater, 04330
        • Harold Alfond Center for Cancer Care
      • Brewer, Maine, Forenede Stater, 04412
        • Lafayette Family Cancer Center-EMMC
      • Scarborough, Maine, Forenede Stater, 04074
        • MaineHealth Maine Medical Center- Scarborough
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21204
        • Greater Baltimore Medical Center
      • Bethesda, Maryland, Forenede Stater, 20892
        • National Institutes of Health Clinical Center
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University of Michigan Rogel Cancer Center
      • Dearborn, Michigan, Forenede Stater, 48124
        • Corewell Health Dearborn Hospital
      • Royal Oak, Michigan, Forenede Stater, 48073
        • Corewell Health William Beaumont University Hospital
      • Troy, Michigan, Forenede Stater, 48085
        • Corewell Health Beaumont Troy Hospital
    • Minnesota
      • Burnsville, Minnesota, Forenede Stater, 55337
        • Fairview Ridges Hospital
      • Burnsville, Minnesota, Forenede Stater, 55337
        • Minnesota Oncology - Burnsville
      • Cambridge, Minnesota, Forenede Stater, 55008
        • Cambridge Medical Center
      • Coon Rapids, Minnesota, Forenede Stater, 55433
        • Mercy Hospital
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        • Fairview Southdale Hospital
      • Fridley, Minnesota, Forenede Stater, 55432
        • Unity Hospital
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        • Fairview Clinics and Surgery Center Maple Grove
      • Maplewood, Minnesota, Forenede Stater, 55109
        • Saint John's Hospital - Healtheast
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        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, Forenede Stater, 55415
        • Hennepin County Medical Center
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        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, Forenede Stater, 55454
        • Health Partners Inc
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • University of Minnesota/Masonic Cancer Center
      • Monticello, Minnesota, Forenede Stater, 55362
        • Monticello Cancer Center
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        • New Ulm Medical Center
      • Princeton, Minnesota, Forenede Stater, 55371
        • Fairview Northland Medical Center
      • Robbinsdale, Minnesota, Forenede Stater, 55422
        • North Memorial Medical Health Center
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        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, Forenede Stater, 55101
        • Regions Hospital
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        • United Hospital
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        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, Forenede Stater, 55082
        • Lakeview Hospital
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        • Ridgeview Medical Center
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        • Rice Memorial Hospital
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        • Minnesota Oncology Hematology PA-Woodbury
      • Wyoming, Minnesota, Forenede Stater, 55092
        • Fairview Lakes Medical Center
    • Missouri
      • Ballwin, Missouri, Forenede Stater, 63011
        • Mercy Oncology and Hematology - Clayton-Clarkson
      • Bolivar, Missouri, Forenede Stater, 65613
        • Central Care Cancer Center - Bolivar
      • Cape Girardeau, Missouri, Forenede Stater, 63703
        • Saint Francis Medical Center
      • Cape Girardeau, Missouri, Forenede Stater, 63703
        • Mercy Cancer Center - Cape Girardeau
      • Farmington, Missouri, Forenede Stater, 63640
        • Parkland Health Center - Farmington
      • Jefferson City, Missouri, Forenede Stater, 65109
        • MU Health Care Goldschmidt Cancer Center
      • Joplin, Missouri, Forenede Stater, 64804
        • Freeman Health System
      • Joplin, Missouri, Forenede Stater, 64804
        • Mercy Hospital Joplin
      • Rolla, Missouri, Forenede Stater, 65401
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Rolla, Missouri, Forenede Stater, 65401
        • Phelps Health Delbert Day Cancer Institute
      • Saint Joseph, Missouri, Forenede Stater, 64506
        • Heartland Regional Medical Center
      • Sainte Genevieve, Missouri, Forenede Stater, 63670
        • Sainte Genevieve County Memorial Hospital
      • Springfield, Missouri, Forenede Stater, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, Forenede Stater, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine
      • St Louis, Missouri, Forenede Stater, 63131
        • Missouri Baptist Medical Center
      • St Louis, Missouri, Forenede Stater, 63109
        • Mercy Infusion Center - Chippewa
      • St Louis, Missouri, Forenede Stater, 63141
        • Mercy Hospital Saint Louis
      • St Louis, Missouri, Forenede Stater, 63128
        • Mercy Hospital South
      • Sullivan, Missouri, Forenede Stater, 63080
        • Missouri Baptist Sullivan Hospital
      • Washington, Missouri, Forenede Stater, 63090
        • Mercy Hospital Washington
    • Montana
      • Anaconda, Montana, Forenede Stater, 59711
        • Community Hospital of Anaconda
      • Billings, Montana, Forenede Stater, 59101
        • Billings Clinic Cancer Center
      • Bozeman, Montana, Forenede Stater, 59715
        • Bozeman Health Deaconess Hospital
      • Great Falls, Montana, Forenede Stater, 59405
        • Great Falls Clinic
      • Great Falls, Montana, Forenede Stater, 59405
        • Benefis Sletten Cancer Institute
      • Kalispell, Montana, Forenede Stater, 59901
        • Logan Health Medical Center
      • Missoula, Montana, Forenede Stater, 59802
        • Saint Patrick Hospital - Community Hospital
      • Missoula, Montana, Forenede Stater, 59804
        • Community Medical Center
    • Nebraska
      • Grand Island, Nebraska, Forenede Stater, 68803
        • Nebraska Cancer Specialists/Oncology Hematology West PC
      • Kearney, Nebraska, Forenede Stater, 68847
        • CHI Health Good Samaritan
      • Lincoln, Nebraska, Forenede Stater, 68510
        • Saint Elizabeth Regional Medical Center
      • Lincoln, Nebraska, Forenede Stater, 68516
        • Cancer Partners of Nebraska
      • Omaha, Nebraska, Forenede Stater, 68114
        • Nebraska Methodist Hospital
      • Omaha, Nebraska, Forenede Stater, 68198
        • University of Nebraska Medical Center
      • Omaha, Nebraska, Forenede Stater, 68124
        • Alegent Health Bergan Mercy Medical Center
      • Omaha, Nebraska, Forenede Stater, 68122
        • Alegent Health Immanuel Medical Center
      • Omaha, Nebraska, Forenede Stater, 68130
        • Alegent Health Lakeside Hospital
      • Papillion, Nebraska, Forenede Stater, 68046
        • Midlands Community Hospital
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89106
        • Women's Cancer Center of Nevada
    • New Jersey
      • Neptune City, New Jersey, Forenede Stater, 07753
        • Jersey Shore Medical Center
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87106
        • University of New Mexico Cancer Center
      • Las Cruces, New Mexico, Forenede Stater, 88011
        • Memorial Medical Center-Las Cruces
      • Rio Rancho, New Mexico, Forenede Stater, 87124
        • Presbyterian Rust Medical Center/Jorgensen Cancer Center
    • New York
      • Bay Shore, New York, Forenede Stater, 11706
        • Northwell Health Imbert Cancer Center
      • Brightwaters, New York, Forenede Stater, 11718
        • Island Gynecologic Oncology
      • Buffalo, New York, Forenede Stater, 14263
        • Roswell Park Cancer Institute
      • Lake Success, New York, Forenede Stater, 11042
        • Northwell Health/Center for Advanced Medicine
      • Syracuse, New York, Forenede Stater, 13210
        • State University of New York Upstate Medical University
      • White Plains, New York, Forenede Stater, 10601
        • Dickstein Cancer Treatment Center
    • North Carolina
      • Clinton, North Carolina, Forenede Stater, 28328
        • Southeastern Medical Oncology Center-Clinton
      • Goldsboro, North Carolina, Forenede Stater, 27534
        • Southeastern Medical Oncology Center-Goldsboro
      • Jacksonville, North Carolina, Forenede Stater, 28546
        • Southeastern Medical Oncology Center-Jacksonville
    • Ohio
      • Akron, Ohio, Forenede Stater, 44304
        • Summa Health System - Akron Campus
      • Alliance, Ohio, Forenede Stater, 44601
        • Aultman Alliance Community Hospital
      • Beachwood, Ohio, Forenede Stater, 44122
        • UHHS-Chagrin Highlands Medical Center
      • Belpre, Ohio, Forenede Stater, 45714
        • Strecker Cancer Center-Belpre
      • Canton, Ohio, Forenede Stater, 44710
        • Aultman Health Foundation
      • Centerville, Ohio, Forenede Stater, 45459
        • Miami Valley Hospital South
      • Chardon, Ohio, Forenede Stater, 44024
        • Geauga Hospital
      • Chillicothe, Ohio, Forenede Stater, 45601
        • Adena Regional Medical Center
      • Cincinnati, Ohio, Forenede Stater, 45220
        • Good Samaritan Hospital - Cincinnati
      • Cincinnati, Ohio, Forenede Stater, 45242
        • Bethesda North Hospital
      • Cincinnati, Ohio, Forenede Stater, 45247
        • TriHealth Cancer Institute-Westside
      • Cincinnati, Ohio, Forenede Stater, 45255
        • TriHealth Cancer Institute-Anderson
      • Cleveland, Ohio, Forenede Stater, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, Forenede Stater, 44111
        • Cleveland Clinic Cancer Center/Fairview Hospital
      • Columbus, Ohio, Forenede Stater, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, Forenede Stater, 43210
        • Ohio State University Comprehensive Cancer Center
      • Columbus, Ohio, Forenede Stater, 43219
        • The Mark H Zangmeister Center
      • Columbus, Ohio, Forenede Stater, 43214
        • Columbus Oncology and Hematology Associates Inc
      • Columbus, Ohio, Forenede Stater, 43228
        • Doctors Hospital
      • Columbus, Ohio, Forenede Stater, 43213
        • Mount Carmel East Hospital
      • Columbus, Ohio, Forenede Stater, 43215
        • Grant Medical Center
      • Columbus, Ohio, Forenede Stater, 43222
        • Mount Carmel Health Center West
      • Dayton, Ohio, Forenede Stater, 45409
        • Miami Valley Hospital
      • Delaware, Ohio, Forenede Stater, 43015
        • Delaware Health Center-Grady Cancer Center
      • Delaware, Ohio, Forenede Stater, 43015
        • Grady Memorial Hospital
      • Dublin, Ohio, Forenede Stater, 43016
        • Dublin Methodist Hospital
      • Gahanna, Ohio, Forenede Stater, 43230
        • Central Ohio Breast and Endocrine Surgery
      • Grove City, Ohio, Forenede Stater, 43123
        • Mount Carmel Grove City Hospital
      • Lancaster, Ohio, Forenede Stater, 43130
        • Fairfield Medical Center
      • Lima, Ohio, Forenede Stater, 45801
        • Saint Rita's Medical Center
      • Mansfield, Ohio, Forenede Stater, 44903
        • OhioHealth Mansfield Hospital
      • Marietta, Ohio, Forenede Stater, 45750
        • Marietta Memorial Hospital
      • Marion, Ohio, Forenede Stater, 43302
        • OhioHealth Marion General Hospital
      • Mayfield Heights, Ohio, Forenede Stater, 44124
        • Hillcrest Hospital Cancer Center
      • Mentor, Ohio, Forenede Stater, 44060
        • UH Seidman Cancer Center at Lake Health Mentor Campus
      • Mount Vernon, Ohio, Forenede Stater, 43050
        • Knox Community Hospital
      • Newark, Ohio, Forenede Stater, 43055
        • Licking Memorial Hospital
      • Newark, Ohio, Forenede Stater, 43055
        • Newark Radiation Oncology
      • Perrysburg, Ohio, Forenede Stater, 43551
        • Mercy Health - Perrysburg Hospital
      • Portsmouth, Ohio, Forenede Stater, 45662
        • Southern Ohio Medical Center
      • Toledo, Ohio, Forenede Stater, 43623
        • Mercy Health - Saint Anne Hospital
      • Toledo, Ohio, Forenede Stater, 43608
        • Mercy Health - Saint Vincent Hospital
      • Wadsworth, Ohio, Forenede Stater, 44281
        • University Hospitals Sharon Health Center
      • Westerville, Ohio, Forenede Stater, 43081
        • Saint Ann's Hospital
      • Westlake, Ohio, Forenede Stater, 44145
        • UH Seidman Cancer Center at Saint John Medical Center
      • Zanesville, Ohio, Forenede Stater, 43701
        • Genesis Healthcare System Cancer Care Center
    • Oklahoma
      • Lawton, Oklahoma, Forenede Stater, 73505
        • Cancer Centers of Southwest Oklahoma Research
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • University of Oklahoma Health Sciences Center
      • Oklahoma City, Oklahoma, Forenede Stater, 73120
        • Mercy Hospital Oklahoma City
      • Tulsa, Oklahoma, Forenede Stater, 74146
        • Oklahoma Cancer Specialists and Research Institute-Tulsa
    • Oregon
      • Baker City, Oregon, Forenede Stater, 97814
        • Saint Alphonsus Cancer Care Center-Baker City
      • Bend, Oregon, Forenede Stater, 97701
        • Saint Charles Health System
      • Clackamas, Oregon, Forenede Stater, 97015
        • Clackamas Radiation Oncology Center
      • Clackamas, Oregon, Forenede Stater, 97015
        • Providence Cancer Institute Clackamas Clinic
      • Coos Bay, Oregon, Forenede Stater, 97420
        • Bay Area Hospital
      • Newberg, Oregon, Forenede Stater, 97132
        • Providence Newberg Medical Center
      • Ontario, Oregon, Forenede Stater, 97914
        • Saint Alphonsus Cancer Care Center-Ontario
      • Portland, Oregon, Forenede Stater, 97210
        • Legacy Good Samaritan Hospital and Medical Center
      • Portland, Oregon, Forenede Stater, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, Forenede Stater, 97225
        • Providence Saint Vincent Medical Center
      • Redmond, Oregon, Forenede Stater, 97756
        • Saint Charles Health System-Redmond
      • Tualatin, Oregon, Forenede Stater, 97062
        • Legacy Meridian Park Hospital
    • Pennsylvania
      • Butler, Pennsylvania, Forenede Stater, 16001
        • UPMC Hillman Cancer Center at Butler Health System
      • Erie, Pennsylvania, Forenede Stater, 16505
        • UPMC Hillman Cancer Center Erie
      • Paoli, Pennsylvania, Forenede Stater, 19301
        • Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, Forenede Stater, 19114
        • Jefferson Torresdale Hospital
      • Pittsburgh, Pennsylvania, Forenede Stater, 15224
        • West Penn Hospital
      • Pittsburgh, Pennsylvania, Forenede Stater, 15232
        • UPMC Hillman Cancer Center
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • UPMC-Magee Womens Hospital
      • Pittsburgh, Pennsylvania, Forenede Stater, 15237
        • UPMC-Passavant Hospital
      • Willow Grove, Pennsylvania, Forenede Stater, 19090
        • Asplundh Cancer Pavilion
      • Wynnewood, Pennsylvania, Forenede Stater, 19096
        • Lankenau Medical Center
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02905
        • Women and Infants Hospital
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Medical University of South Carolina
      • Greenville, South Carolina, Forenede Stater, 29607
        • Saint Francis Cancer Center
      • Greenville, South Carolina, Forenede Stater, 29601
        • Saint Francis Hospital
    • South Dakota
      • Rapid City, South Dakota, Forenede Stater, 57701
        • Rapid City Regional Hospital
    • Tennessee
      • Bristol, Tennessee, Forenede Stater, 37620
        • Bristol Regional Medical Center
      • Kingsport, Tennessee, Forenede Stater, 37660
        • Ballad Health Cancer Care - Kingsport
      • Kingsport, Tennessee, Forenede Stater, 37660
        • Wellmont Holston Valley Hospital and Medical Center
      • Knoxville, Tennessee, Forenede Stater, 37916
        • Covenant Health Cancer Centers
      • Knoxville, Tennessee, Forenede Stater, 37932
        • Covenant Health Cancer Centers - West
      • Nashville, Tennessee, Forenede Stater, 37232
        • Vanderbilt University/Ingram Cancer Center
      • Nashville, Tennessee, Forenede Stater, 37204
        • Vanderbilt Breast Center at One Hundred Oaks
    • Texas
      • Bryan, Texas, Forenede Stater, 77802
        • Saint Joseph Regional Cancer Center
      • Dallas, Texas, Forenede Stater, 75235
        • Parkland Memorial Hospital
      • Dallas, Texas, Forenede Stater, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Houston, Texas, Forenede Stater, 77030
        • Houston Methodist Hospital
      • Houston, Texas, Forenede Stater, 77070
        • Methodist Willowbrook Hospital
      • Houston, Texas, Forenede Stater, 77094
        • Houston Methodist West Hospital
      • Sugar Land, Texas, Forenede Stater, 77479
        • Houston Methodist Sugar Land Hospital
      • The Woodlands, Texas, Forenede Stater, 77385
        • Houston Methodist The Woodlands Hospital
    • Virginia
      • Bristol, Virginia, Forenede Stater, 24201
        • Ballad Health Cancer Care - Bristol
      • Norton, Virginia, Forenede Stater, 24273
        • Ballad Health Cancer Care - Norton
    • Washington
      • Aberdeen, Washington, Forenede Stater, 98520
        • Providence Regional Cancer System-Aberdeen
      • Bellingham, Washington, Forenede Stater, 98225
        • PeaceHealth Saint Joseph Medical Center
      • Burien, Washington, Forenede Stater, 98166
        • Saint Anne Hospital
      • Centralia, Washington, Forenede Stater, 98531
        • Providence Regional Cancer System-Centralia
      • Edmonds, Washington, Forenede Stater, 98026
        • Swedish Cancer Institute-Edmonds
      • Enumclaw, Washington, Forenede Stater, 98022
        • Saint Elizabeth Hospital
      • Everett, Washington, Forenede Stater, 98201
        • Providence Regional Cancer Partnership
      • Federal Way, Washington, Forenede Stater, 98003
        • Saint Francis Hospital
      • Issaquah, Washington, Forenede Stater, 98029
        • Swedish Cancer Institute-Issaquah
      • Kennewick, Washington, Forenede Stater, 99336
        • Kadlec Clinic Hematology and Oncology
      • Lacey, Washington, Forenede Stater, 98503
        • Providence Regional Cancer System-Lacey
      • Lakewood, Washington, Forenede Stater, 98499
        • Saint Clare Hospital
      • Longview, Washington, Forenede Stater, 98632
        • PeaceHealth Saint John Medical Center
      • Port Townsend, Washington, Forenede Stater, 98368
        • Jefferson Healthcare
      • Seattle, Washington, Forenede Stater, 98107
        • Swedish Medical Center-Ballard Campus
      • Seattle, Washington, Forenede Stater, 98122
        • Swedish Medical Center-First Hill
      • Seattle, Washington, Forenede Stater, 98104
        • Pacific Gynecology Specialists
      • Seattle, Washington, Forenede Stater, 98122-5711
        • Swedish Medical Center-Cherry Hill
      • Sedro-Woolley, Washington, Forenede Stater, 98284
        • PeaceHealth United General Medical Center
      • Shelton, Washington, Forenede Stater, 98584
        • Providence Regional Cancer System-Shelton
      • Silverdale, Washington, Forenede Stater, 98383
        • Saint Joseph Medical Center Hematology and Oncology - Silverdale
      • Tacoma, Washington, Forenede Stater, 98405
        • Franciscan Research Center-Northwest Medical Plaza
      • Vancouver, Washington, Forenede Stater, 98686
        • Legacy Salmon Creek Hospital
      • Vancouver, Washington, Forenede Stater, 98664
        • PeaceHealth Southwest Medical Center
      • Walla Walla, Washington, Forenede Stater, 99362
        • Providence Saint Mary Regional Cancer Center
      • Yelm, Washington, Forenede Stater, 98597
        • Providence Regional Cancer System-Yelm
    • West Virginia
      • Charleston, West Virginia, Forenede Stater, 25304
        • Vandalia Health/CAMC Institute for Academic Medicine
    • Wisconsin
      • Green Bay, Wisconsin, Forenede Stater, 54301
        • Saint Vincent Hospital Cancer Center Green Bay
      • Green Bay, Wisconsin, Forenede Stater, 54303
        • Saint Vincent Hospital Cancer Center at Saint Mary's
      • La Crosse, Wisconsin, Forenede Stater, 54601
        • Gundersen Lutheran Medical Center
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Medical College of Wisconsin
      • Mukwonago, Wisconsin, Forenede Stater, 53149
        • ProHealth D N Greenwald Center
      • New Richmond, Wisconsin, Forenede Stater, 54017
        • Cancer Center of Western Wisconsin
      • Oconomowoc, Wisconsin, Forenede Stater, 53066
        • ProHealth Oconomowoc Memorial Hospital
      • Oconto Falls, Wisconsin, Forenede Stater, 54154
        • Saint Vincent Hospital Cancer Center at Oconto Falls
      • Sturgeon Bay, Wisconsin, Forenede Stater, 54235-1495
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
      • Waukesha, Wisconsin, Forenede Stater, 53188
        • UW Cancer Center at ProHealth Care
      • Waukesha, Wisconsin, Forenede Stater, 53188
        • ProHealth Waukesha Memorial Hospital
    • Wyoming
      • Cody, Wyoming, Forenede Stater, 82414
        • Billings Clinic-Cody
      • Sheridan, Wyoming, Forenede Stater, 82801
        • Welch Cancer Center
  • Puerto Rico
      • Bayamón, Puerto Rico, 00959-5060
        • Cancer Center-Metro Medical Center Bayamon
      • Caguas, Puerto Rico, 00726
        • HIMA San Pablo Oncologic Hospital
      • Manati, Puerto Rico, 00674
        • Doctors Cancer Center
      • Ponce, Puerto Rico, 00716
        • Instituto Oncologia Moderna Ponce
      • San Juan, Puerto Rico, 00917
        • San Juan Community Oncology Group
      • San Juan, Puerto Rico, 00927
        • Centro Comprensivo de Cancer de UPR
      • San Juan, Puerto Rico, 00936
        • San Juan City Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Women with recurrent/persistent platinum-resistant ovarian, primary peritoneal, or fallopian tube cancers; platinum-resistant disease is defined as progression within < 6 months from completion of platinum based therapy. The date should be calculated from the last administered dose of platinum therapy

  • Patients must have histologically or cytologically confirmed ovarian cancer, peritoneal cancer or fallopian tube cancer and must have a histological diagnosis of high grade serous, grade 3 endometrioid or clear cell carcinoma based on local histopathological findings. Patients with low grade serous, grade 1 or 2 endometrioid, mixed epithelial, undifferentiated carcinoma, or mucinous carcinoma histologies are also eligible, provided that the patient has a known deleterious BRCA1 or BRCA2 mutation identified through testing at a clinical laboratory. Histologic confirmation of the original primary tumor is required via the pathology report (upload of report required). Confirmation of BRCA1 and BRCA2 germline and/or somatic mutation status and hormone receptor (HR) status is required for all entered patients (if available) via testing report (upload of report[s] required)

  • Evaluable disease - defined as RECIST 1.1 measurable disease OR non-measurable disease (defined as solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions OR ascites and/or pleural effusion that has been pathologically demonstrated to be disease-related in the setting of a CA125 >= 2 x upper limit of normal [ULN])

  • Prior therapy:

    • At least two prior treatment regimens (including primary therapy) but up to 5 lines of systemic anticancer therapy. Hormonal therapy (such as tamoxifen, aromatase inhibitors) will not count as a previous treatment regimen.
    • Prior use of bevacizumab in the upfront or recurrent setting is required.
    • Prior use of PARP inhibitor is allowed.
    • Prior use of immune checkpoint blockade (e.g., a PD-L1/PD-1inhibitor or a CTLA-4 inhibitor) is allowed

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

  • Absolute neutrophil count (ANC) >= 1,500/mcL

  • Hemoglobin >= 10 g/dL

  • Platelets >= 100,000/mcL

  • Creatinine clearance (CrCL) or estimated glomerular filtration rate (eGFR) of > 50 mL/min estimated using either the Cockcroft-Gault equation, the Modification of Diet in Renal Disease Study, or as reported in the comprehensive metabolic panel/basic metabolic panel (eGFR)

  • Urine protein: creatinine ratio (UPC) of =< 1

  • Total serum bilirubin level =< 1.5 x ULN (patients with known Gilbert's disease who have bilirubin level =< 3 x ULN may be enrolled)

  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN

  • Age >= 18 years

  • Body weight > 30 kg

  • Adequately controlled blood pressure (systolic blood pressure [SBP] =< 140; diastolic blood pressure [DBP] =< 90 mmHg) on a maximum of three antihypertensive medications. Patients must have a BP of =< 140/90 mmHg taken in the clinic setting by a medical professional within 2 weeks prior to study registration. It is strongly recommended that patients who are on three antihypertensive medications be followed by a cardiologist or a primary care physician for management of BP while on protocol. Patients must be willing and able to check and record daily blood pressure readings. BP cuffs will be provided to patients randomized to the cediranib-containing arms

  • Adequately controlled thyroid dysfunction with no symptoms of thyroid dysfunction and normal thyroid stimulating hormone (TSH). If TSH is not within normal range despite no symptoms of thyroid dysfunction, normal free T4 level is required

  • Able to swallow and retain oral medications and no gastrointestinal (GI) illnesses that would preclude absorption of olaparib and cediranib as judged by treating physician

  • Toxicities of prior therapy (excepting alopecia and vitiligo), should be resolved to less than or equal to grade 1 as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  • Women of childbearing potential (WOCBP) must agree to use two forms of birth control (hormonal or barrier method of birth control; abstinence). Note: Definition of women of no longer having childbearing potential: Postmenopausal or evidence of non-childbearing status for women of childbearing potential as confirmed by a negative urine or serum pregnancy test within 7 days prior to start of study treatment. Postmenopausal is defined as: Age >= 60 years, or age < 60 with any one or more of the conditions below:

    • Amenorrhoeic for >= 1 year in the absence of chemotherapy and/or hormonal treatments,
    • Luteinizing hormone and/or follicle stimulating hormone and/or estradiol levels in the post-menopausal range,
    • Radiation-induced oophorectomy with last menses > 1 year ago,
    • Chemotherapy-induced menopause with > 1 year interval since last menses,
    • Surgical sterilization (bilateral oophorectomy or hysterectomy)

  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and authorization permitting release of personal health information

Exclusion Criteria:

  • Primary platinum-refractory disease defined as progression during first-line platinum-based chemotherapy

  • Rising CA-125 only without RECIST 1.1 evaluable disease

  • Prior therapy:

    • Patients who have had chemotherapy, investigational drugs or radiotherapy within 3 weeks prior to study registration or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier.

    • Patients may not have had hormonal therapy within 2 weeks of study registration. Patients receiving raloxifene for bone health as per Food and Drug Administration (FDA) indication may remain on raloxifene absent other drug interactions.

    • Prior use of concurrent olaparib and cediranib combination.

    • Patients who have experienced immune-mediated adverse events requiring dose modification or discontinuation.

    • For patients who have received prior PARP inhibitor:

      • Patients who have required dose modification or dose reduction of olaparib will not be eligible, as they will not be able to start this study at full dose.
      • Patients who have required dose reduction of non-olaparib PARP inhibitors for hematologic adverse events will not be eligible (Note: niraparib that is initiated at 200mg daily per weight and platelet guidelines is not considered a dose reduction).
      • Patients who required dose-reduction of non-olaparib PARP inhibitors for non-hematologic adverse events may be eligible after discussion with the Study Chair if the treating investigator feels that they could appropriately receive olaparib at full dose.

  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 3 months prior to study registration

  • Current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 3 months of study registration except temporary (< 24 hr) improved with medical management, within last 3 months

  • Any prior grade >= 3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE > grade 1

  • Dependency on IV hydration or total parenteral nutrition (TPN)

  • Pregnant women. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with these drugs, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study

  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

  • Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on computed tomography (CT) or magnetic resonance imaging (MRI) scans should not be included on this study, since neurologic dysfunction may confound the evaluation of neurologic and other adverse events. Patients with treated brain metastases and resolution of any associated symptoms must demonstrate stable post-therapeutic imaging for at least 6 months following therapy prior to starting study registration

  • Patients who have the following clinical conditions are considered to be at increased risk for cardiac toxicities. Patients with any cardiac history of the following conditions:

    • History of myocardial infarction or myocarditis within six months of study registration
    • Unstable angina
    • Resting electrocardiogram (ECG) with clinically significant abnormal findings.
    • New York Heart Association functional classification of III or IV

  • If cardiac function assessment is clinically indicated or performed: left ventricular ejection fraction (LVEF) less than normal per institutional guidelines, or < 55%, if threshold for normal not otherwise specified by institutional guidelines. Patients with the following risk factors should have a baseline cardiac function assessment:

    • Prior treatment with anthracyclines
    • Prior treatment with trastuzumab or T-DM1
    • Prior central thoracic radiation therapy (RT), including RT to the heart
    • History of myocardial infarction within 6 to 12 months (Patients with history of myocardial infarction within 6 months are excluded from the study)
    • Prior history of impaired cardiac function

  • History of stroke or transient ischemic attack within six months of study registration

  • Clinically significant peripheral vascular disease or vascular disease (aortic aneurysm or aortic dissection)

  • Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study treatment. Patients must have recovered from any effects of any major surgery and surgical wound should have healed prior to starting treatment. Note: Local surgery of isolated lesions for palliative intent is acceptable

  • Evidence of coagulopathy or bleeding diathesis. Therapeutic anticoagulation for prior thromboembolic events, including warfarin, is permitted. Patients receiving warfarin are recommended to have careful monitoring of international normalized ratio (INR)

  • Evidence suggestive of myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) on peripheral blood smear or bone marrow biopsy, if clinically indicated. No prior allogeneic bone marrow transplant or double umbilical cord blood transplantation (dUBCT)

  • Human immunodeficiency virus (HIV) positive patients due to potential drug and drug interactions

  • Patients may not use any complementary or alternative medicines including natural herbal products or folk remedies as they may interfere with the effectiveness of the study treatments

  • Receipt of live attenuated vaccine within 30 days prior to the first dose of study treatment. Note: Patients, if enrolled, should not receive live vaccine whilst receiving study treatment and up to 30 days after the last dose of study treatment

  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (other than atrial fibrillation with controlled ventricular rate), or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring adverse events or compromise the ability of the patient to given written informed consent

  • Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4. Dihydropyridine calcium-channel blockers are permitted for management of hypertension

  • Current or prior use of immunosuppressive medication within 14 days of study registration. The following are exceptions to this criterion:

    • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
    • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
    • Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)

  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to durvalumab, olaparib, or cediranib

  • Patients with active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment

  • Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis [TB] testing in line with local practice), hepatitis B (known positive hepatitis B virus [HBV] surface antigen (HBsAg) result), or hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for hepatitis C virus (HCV) ribonucleic acid (RNA)

  • Patients who have a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Arm I (paclitaxel, doxorubicin, topotecan hydrochloride))

Patients receive paclitaxel IV over 60 minutes on days 1, 8, and 15, or pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1, or topotecan hydrochloride IV over 30 minutes on days 1, 8 and 15 or days 1-5 per the discretion of the treating physician. Cycles repeat every 21 or 28 days in the absence of disease progression or unacceptable toxicity. Patients may undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo collection of blood and CT with contrast during screening, and CT or MRI scans throughout the trial.
Medicin: Paclitaxel

Given IV

Andre navne:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat
Procedure: Computed Tomography

Undergo CT

Andre navne:
  • CT
  • KAT
  • CAT-scanning
  • Beregnet aksial tomografi
  • Computerstyret aksial tomografi
  • Computerstyret tomografi
  • CT-scanning
  • tomografi
  • Computerstyret aksial tomografi (procedure)
  • Computerstyret tomografi (CT) scanning
  • Diagnostisk CAT -scanning
  • Diagnostic CAT Scan Service Type
Procedure: Magnetic Resonance Imaging

Undergo MRI

Andre navne:
  • MR
  • Magnetisk resonans
  • Magnetisk resonansbilledscanning
  • Medicinsk billeddannelse, magnetisk resonans / kernemagnetisk resonans
  • HR
  • MR billeddannelse
  • MR-scanning
  • NMR billeddannelse
  • NMRI
  • Kernemagnetisk resonansbilleddannelse
  • Magnetisk resonansbilleddannelse (MRI)
  • sMRI
  • Magnetisk resonansbilleddannelse (procedure)
  • MRI'er
  • Strukturel MR
Procedure: Echocardiography Test

Undergo ECHO

Andre navne:
  • Ekkokardiografi
  • EC
Procedure: Multigated Acquisition Scan

Undergo MUGA

Andre navne:
  • Blood Pool Scan
  • Ligevægtsradionuklidangiografi
  • Gated Blood Pool Imaging
  • MUGA
  • Radionuklid ventrikulografi
  • RNVG
  • SYMA-scanning
  • Synkroniseret Multigated Acquisition Scanning
  • MUGA Scan
  • Multi-Gated Acquisition Scan
  • Radionuklid Ventrikulogram Scan
  • Gated Heart Pool Scan
  • RNV Scan
Procedure: Biospecimen Collection

Undergo collection of blood

Andre navne:
  • Biologisk prøvesamling
  • Bioprøve indsamlet
  • Prøvesamling
  • Prøvekollektion
Medicin: Pegylated Liposomal Doxorubicin Hydrochloride

Given IV

Andre navne:
  • ATI-0918
  • Caelyx
  • Doxil
  • Doxilen
  • Doxorubicin HCl liposom
  • Duomeisu
  • Evacet
  • LipoDox
  • Liposomal Adriamycin
  • Liposomal-indkapslet doxorubicin
  • Pegyleret doxorubicin HCl liposom
  • S-liposomal doxorubicin
  • Stealth Liposomal Doxorubicin
  • TLC D-99
  • Dox-SL
  • Doxorubicin HCl Liposomal
  • Doxorubicin hydrochlorid liposom
  • Lipodox 50
  • Liposomal doxorubicin hydrochlorid
  • Pegyleret liposomalt doxorubicin
  • Doxorubicin liposomal
Medicin: Topotecan Hydrochloride

Given IV

Andre navne:
  • Hycamtin
  • Hycamptamin
  • SKF S-104864-A
  • Topotecan HCl
  • topotecan hydrochlorid (oral)
  • Potactasol
  • Evotopin
  • Topotec
  • Nogitecan Hydrochlorid
  • SKF S 104864 A
  • SKF S104864A
Procedure: Computed Tomography with Contrast

Undergo CT with contrast

Andre navne:
  • Kontrastforbedret computertomografi
  • KONTRAST FORBEDRET CT-SCANNING
  • Kontrastforstærket computertomografi
  • CT-scanning med kontrast
  • CT med kontrast
Eksperimentel: Arm II (durvalumab, cediranib maleate, olaparib)

Patients receive durvalumab IV over 60 minutes on day 1, cediranib maleate PO QD Monday through Friday, and olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo collection of blood and CT with contrast during screening, and CT or MRI scans throughout the trial.
Procedure: Computed Tomography

Undergo CT

Andre navne:
  • CT
  • KAT
  • CAT-scanning
  • Beregnet aksial tomografi
  • Computerstyret aksial tomografi
  • Computerstyret tomografi
  • CT-scanning
  • tomografi
  • Computerstyret aksial tomografi (procedure)
  • Computerstyret tomografi (CT) scanning
  • Diagnostisk CAT -scanning
  • Diagnostic CAT Scan Service Type
Procedure: Magnetic Resonance Imaging

Undergo MRI

Andre navne:
  • MR
  • Magnetisk resonans
  • Magnetisk resonansbilledscanning
  • Medicinsk billeddannelse, magnetisk resonans / kernemagnetisk resonans
  • HR
  • MR billeddannelse
  • MR-scanning
  • NMR billeddannelse
  • NMRI
  • Kernemagnetisk resonansbilleddannelse
  • Magnetisk resonansbilleddannelse (MRI)
  • sMRI
  • Magnetisk resonansbilleddannelse (procedure)
  • MRI'er
  • Strukturel MR
Procedure: Echocardiography Test

Undergo ECHO

Andre navne:
  • Ekkokardiografi
  • EC
Procedure: Multigated Acquisition Scan

Undergo MUGA

Andre navne:
  • Blood Pool Scan
  • Ligevægtsradionuklidangiografi
  • Gated Blood Pool Imaging
  • MUGA
  • Radionuklid ventrikulografi
  • RNVG
  • SYMA-scanning
  • Synkroniseret Multigated Acquisition Scanning
  • MUGA Scan
  • Multi-Gated Acquisition Scan
  • Radionuklid Ventrikulogram Scan
  • Gated Heart Pool Scan
  • RNV Scan
Procedure: Biospecimen Collection

Undergo collection of blood

Andre navne:
  • Biologisk prøvesamling
  • Bioprøve indsamlet
  • Prøvesamling
  • Prøvekollektion
Medicin: Cediranib Maleate

Given PO

Andre navne:
  • AZD2171
  • AZD2171 maleat
  • Recentin
Medicin: Olaparib

Given PO

Andre navne:
  • Lynparza
  • AZD 2281
  • AZD-2281
  • AZD2281
  • KU-0059436
  • PARP-hæmmer AZD2281
  • KU0059436
  • Olanib
  • Olaparix
  • KU 0059436
Procedure: Computed Tomography with Contrast

Undergo CT with contrast

Andre navne:
  • Kontrastforbedret computertomografi
  • KONTRAST FORBEDRET CT-SCANNING
  • Kontrastforstærket computertomografi
  • CT-scanning med kontrast
  • CT med kontrast
Biologisk: Durvalumab

Given IV

Andre navne:
  • Imfinzi
  • Immunoglobulin G1, Anti-(Humant Protein B7-H1) (Human Monoklonal MEDI4736 Heavy Chain), Disulfid med Human Monoklonal MEDI4736 Kappa-kæde, Dimer
  • MEDI-4736
  • MEDI4736
  • MEDI 4736
Eksperimentel: Arm III (durvalumab, cediranib maleate)

Patients receive durvalumab IV over 60 minutes on day 1 and cediranib maleate PO QD Monday through Friday. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo collection of blood and CT with contrast during screening, and CT or MRI scans throughout the trial.
Procedure: Computed Tomography

Undergo CT

Andre navne:
  • CT
  • KAT
  • CAT-scanning
  • Beregnet aksial tomografi
  • Computerstyret aksial tomografi
  • Computerstyret tomografi
  • CT-scanning
  • tomografi
  • Computerstyret aksial tomografi (procedure)
  • Computerstyret tomografi (CT) scanning
  • Diagnostisk CAT -scanning
  • Diagnostic CAT Scan Service Type
Procedure: Magnetic Resonance Imaging

Undergo MRI

Andre navne:
  • MR
  • Magnetisk resonans
  • Magnetisk resonansbilledscanning
  • Medicinsk billeddannelse, magnetisk resonans / kernemagnetisk resonans
  • HR
  • MR billeddannelse
  • MR-scanning
  • NMR billeddannelse
  • NMRI
  • Kernemagnetisk resonansbilleddannelse
  • Magnetisk resonansbilleddannelse (MRI)
  • sMRI
  • Magnetisk resonansbilleddannelse (procedure)
  • MRI'er
  • Strukturel MR
Procedure: Echocardiography Test

Undergo ECHO

Andre navne:
  • Ekkokardiografi
  • EC
Procedure: Multigated Acquisition Scan

Undergo MUGA

Andre navne:
  • Blood Pool Scan
  • Ligevægtsradionuklidangiografi
  • Gated Blood Pool Imaging
  • MUGA
  • Radionuklid ventrikulografi
  • RNVG
  • SYMA-scanning
  • Synkroniseret Multigated Acquisition Scanning
  • MUGA Scan
  • Multi-Gated Acquisition Scan
  • Radionuklid Ventrikulogram Scan
  • Gated Heart Pool Scan
  • RNV Scan
Procedure: Biospecimen Collection

Undergo collection of blood

Andre navne:
  • Biologisk prøvesamling
  • Bioprøve indsamlet
  • Prøvesamling
  • Prøvekollektion
Medicin: Cediranib Maleate

Given PO

Andre navne:
  • AZD2171
  • AZD2171 maleat
  • Recentin
Procedure: Computed Tomography with Contrast

Undergo CT with contrast

Andre navne:
  • Kontrastforbedret computertomografi
  • KONTRAST FORBEDRET CT-SCANNING
  • Kontrastforstærket computertomografi
  • CT-scanning med kontrast
  • CT med kontrast
Biologisk: Durvalumab

Given IV

Andre navne:
  • Imfinzi
  • Immunoglobulin G1, Anti-(Humant Protein B7-H1) (Human Monoklonal MEDI4736 Heavy Chain), Disulfid med Human Monoklonal MEDI4736 Kappa-kæde, Dimer
  • MEDI-4736
  • MEDI4736
  • MEDI 4736
Eksperimentel: Arm IV (cediranib maleate, olaparib)

Patients receive cediranib maleate PO QD on days 1-28 and olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo collection of blood and CT with contrast during screening, and CT or MRI scans throughout the trial.
Procedure: Computed Tomography

Undergo CT

Andre navne:
  • CT
  • KAT
  • CAT-scanning
  • Beregnet aksial tomografi
  • Computerstyret aksial tomografi
  • Computerstyret tomografi
  • CT-scanning
  • tomografi
  • Computerstyret aksial tomografi (procedure)
  • Computerstyret tomografi (CT) scanning
  • Diagnostisk CAT -scanning
  • Diagnostic CAT Scan Service Type
Procedure: Magnetic Resonance Imaging

Undergo MRI

Andre navne:
  • MR
  • Magnetisk resonans
  • Magnetisk resonansbilledscanning
  • Medicinsk billeddannelse, magnetisk resonans / kernemagnetisk resonans
  • HR
  • MR billeddannelse
  • MR-scanning
  • NMR billeddannelse
  • NMRI
  • Kernemagnetisk resonansbilleddannelse
  • Magnetisk resonansbilleddannelse (MRI)
  • sMRI
  • Magnetisk resonansbilleddannelse (procedure)
  • MRI'er
  • Strukturel MR
Procedure: Echocardiography Test

Undergo ECHO

Andre navne:
  • Ekkokardiografi
  • EC
Procedure: Biospecimen Collection

Undergo collection of blood

Andre navne:
  • Biologisk prøvesamling
  • Bioprøve indsamlet
  • Prøvesamling
  • Prøvekollektion
Medicin: Cediranib Maleate

Given PO

Andre navne:
  • AZD2171
  • AZD2171 maleat
  • Recentin
Medicin: Olaparib

Given PO

Andre navne:
  • Lynparza
  • AZD 2281
  • AZD-2281
  • AZD2281
  • KU-0059436
  • PARP-hæmmer AZD2281
  • KU0059436
  • Olanib
  • Olaparix
  • KU 0059436
Procedure: Computed Tomography with Contrast

Undergo CT with contrast

Andre navne:
  • Kontrastforbedret computertomografi
  • KONTRAST FORBEDRET CT-SCANNING
  • Kontrastforstærket computertomografi
  • CT-scanning med kontrast
  • CT med kontrast

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression Free Survival
Tidsramme: From start of treatment to time of progression or death, whichever occurs first. Median follow-up time was 4.8 months (Inter-Quartile Range: 2.0-7.9 months).

The relationship of randomized treatment assignment to progression free survival. The RECIST 1.1 criteria are used for disease progression. Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
From start of treatment to time of progression or death, whichever occurs first. Median follow-up time was 4.8 months (Inter-Quartile Range: 2.0-7.9 months).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective Response Rate
Tidsramme: From the start of the treatment until disease progression/recurrence, or termination by the DMC. The median followup time was 4.3 months. The maximum followup time was 11 months. Patients are no longer being assessed.

Determination of response should take into consideration all target and non-target lesions. Here are the definitions of CR, PR, PD and SD: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters (i.e. the nadir) while on study. The CI is the Jeffreys interval.
From the start of the treatment until disease progression/recurrence, or termination by the DMC. The median followup time was 4.3 months. The maximum followup time was 11 months. Patients are no longer being assessed.
Duration of Response
Tidsramme: Throughout study treatment, up to 10.6 months.

Tumor response was assessed using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) criteria. Duration of response was defined as the time from the first documentation of objective tumor response (complete response (CR) or partial response (PR)) to the first documented progressive disease (PD), or to death due to any cause, whichever occurs first.

Per RECIST, Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as an >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Reporting the number of months from complete or partial response until disease progression, death or censoring, whichever occurs first. In the absence of disease progression or death, censoring time is based on date of last CT scan.
Throughout study treatment, up to 10.6 months.
Overall Survival
Tidsramme: Time from study entry to date of death from any cause, or termination by the DMC. The median followup time was 4.3 months. The maximum followup time was 11 months. Patients are no longer being assessed.

Overall survival will be presented by Kaplan Meier methods. Overall Survival (OS) is defined as the duration of time from study entry to date of death from any cause. A subject who has not died will be censored on the date that they were last known to be alive.
Time from study entry to date of death from any cause, or termination by the DMC. The median followup time was 4.3 months. The maximum followup time was 11 months. Patients are no longer being assessed.
Count of Participants With a Grade 3 (or Higher) Adverse Event
Tidsramme: From the start of treatment until disease progression/recurrence or termination by the DMC. The median followup time was 4.3 months. The maximum followup time was 11 months. Patients are no longer being assessed.

The number of patients (in each reporting group) who experienced a grade 3 (or higher) adverse event
From the start of treatment until disease progression/recurrence or termination by the DMC. The median followup time was 4.3 months. The maximum followup time was 11 months. Patients are no longer being assessed.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Cancer Institute (NCI)

Samarbejdspartnere

NRG Oncology

Efterforskere

  • Ledende efterforsker: Jung-min Lee, NRG Oncology

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. juni 2021

Primær færdiggørelse (Faktiske)

26. januar 2023

Studieafslutning (Anslået)

25. juni 2027

Datoer for studieregistrering

Først indsendt

4. februar 2021

Først indsendt, der opfyldte QC-kriterier

4. februar 2021

Først opslået (Faktiske)

5. februar 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. oktober 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NCI-2021-00615
  • U10CA180868 (U.S. NIH-bevilling/kontrakt)
  • NCI-2021-00615 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • NRG-GY023 (Anden identifikator: CTEP)
  • NRG-GY023 (Anden identifikator: NRG Oncology)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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