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표적 면역치료제의 삼중 조합과 표준 치료 치료의 비교

2026년 10월 21일 업데이트: National Cancer Institute (NCI)

백금 내성 재발 상피 여성에서 올라파립 및 세디라닙 또는 Durvalumab(MEDI4736) 및 세디라닙 또는 표준 치료 화학 요법과 비교한 삼중 항 요법(PD-L1 억제제 Durvalumab(MEDI4736)과 Olaparib 및 Cediranib의 병용)의 무작위 2상 시험 이전에 베바시주맙을 투여받은 난소암, 원발성 복막암 또는 나팔관암

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.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

120

단계

  • 2 단계

연락처 및 위치

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연구 장소

  • 미국
    • Alaska
      • Anchorage, Alaska, 미국, 98508
        • Anchorage Associates in Radiation Medicine
      • Anchorage, Alaska, 미국, 99508
        • Alaska Breast Care and Surgery LLC
      • Anchorage, Alaska, 미국, 99508
        • Alaska Oncology and Hematology LLC
      • Anchorage, Alaska, 미국, 99508
        • Alaska Women's Cancer Care
      • Anchorage, Alaska, 미국, 99508
        • Anchorage Oncology Centre
      • Anchorage, Alaska, 미국, 99508
        • Katmai Oncology Group
      • Anchorage, Alaska, 미국, 99508
        • Providence Alaska Medical Center
      • Anchorage, Alaska, 미국, 99504
        • Anchorage Radiation Therapy Center
      • Fairbanks, Alaska, 미국, 99701
        • Fairbanks Memorial Hospital
    • Arizona
      • Goodyear, Arizona, 미국, 85338
        • CTCA at Western Regional Medical Center
      • Phoenix, Arizona, 미국, 85004
        • Cancer Center at Saint Joseph's
    • Arkansas
      • Fort Smith, Arkansas, 미국, 72903
        • Mercy Hospital Fort Smith
      • Hot Springs, Arkansas, 미국, 71913
        • CHI Saint Vincent Cancer Center Hot Springs
      • Little Rock, Arkansas, 미국, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Arroyo Grande, California, 미국, 93420
        • Mission Hope Medical Oncology - Arroyo Grande
      • Auburn, California, 미국, 95602
        • Sutter Auburn Faith Hospital
      • Auburn, California, 미국, 95603
        • Sutter Cancer Centers Radiation Oncology Services-Auburn
      • Berkeley, California, 미국, 94704
        • Alta Bates Summit Medical Center-Herrick Campus
      • Burbank, California, 미국, 91505
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • Cameron Park, California, 미국, 95682
        • Sutter Cancer Centers Radiation Oncology Services-Cameron Park
      • Castro Valley, California, 미국, 94546
        • Eden Hospital Medical Center
      • Concord, California, 미국, 94520
        • John Muir Medical Center-Concord
      • Davis, California, 미국, 95616
        • Sutter Davis Hospital
      • Duarte, California, 미국, 91010
        • City of Hope Comprehensive Cancer Center
      • Fremont, California, 미국, 94538
        • Palo Alto Medical Foundation-Fremont
      • Lancaster, California, 미국, 93534
        • City of Hope Antelope Valley
      • Los Angeles, California, 미국, 90033
        • USC / Norris Comprehensive Cancer Center
      • Los Angeles, California, 미국, 90033
        • Los Angeles General Medical Center
      • Modesto, California, 미국, 95355
        • Memorial Medical Center
      • Mountain View, California, 미국, 94040
        • Palo Alto Medical Foundation-Camino Division
      • Mountain View, California, 미국, 94040
        • Palo Alto Medical Foundation-Gynecologic Oncology
      • Palo Alto, California, 미국, 94301
        • Palo Alto Medical Foundation Health Care
      • Roseville, California, 미국, 95661
        • Sutter Cancer Centers Radiation Oncology Services-Roseville
      • Roseville, California, 미국, 95661
        • Sutter Roseville Medical Center
      • Sacramento, California, 미국, 95816
        • Sutter Medical Center Sacramento
      • San Francisco, California, 미국, 94115
        • California Pacific Medical Center-Pacific Campus
      • San Luis Obispo, California, 미국, 93401
        • Pacific Central Coast Health Center-San Luis Obispo
      • Santa Cruz, California, 미국, 95065
        • Palo Alto Medical Foundation-Santa Cruz
      • Santa Maria, California, 미국, 93444
        • Mission Hope Medical Oncology - Santa Maria
      • Santa Rosa, California, 미국, 95403
        • Sutter Pacific Medical Foundation
      • South Pasadena, California, 미국, 91030
        • City of Hope South Pasadena
      • Sunnyvale, California, 미국, 94086
        • Palo Alto Medical Foundation-Sunnyvale
      • Upland, California, 미국, 91786
        • City of Hope Upland
      • Vallejo, California, 미국, 94589
        • Sutter Solano Medical Center/Cancer Center
      • Walnut Creek, California, 미국, 94598
        • John Muir Medical Center-Walnut Creek
    • Colorado
      • Aurora, Colorado, 미국, 80012
        • Rocky Mountain Cancer Centers-Aurora
      • Boulder, Colorado, 미국, 80304
        • Rocky Mountain Cancer Centers-Boulder
      • Centennial, Colorado, 미국, 80112
        • Rocky Mountain Cancer Centers - Centennial
      • Colorado Springs, Colorado, 미국, 80907
        • Penrose-Saint Francis Healthcare
      • Colorado Springs, Colorado, 미국, 80907
        • Rocky Mountain Cancer Centers-Penrose
      • Denver, Colorado, 미국, 80210
        • AdventHealth Porter
      • Durango, Colorado, 미국, 81301
        • Mercy Medical Center
      • Durango, Colorado, 미국, 81301
        • CommonSpirit Cancer Center Mercy
      • Lakewood, Colorado, 미국, 80228
        • CommonSpirit Saint Anthony Hospital Cancer Center
      • Littleton, Colorado, 미국, 80120
        • Rocky Mountain Cancer Centers-Littleton
      • Littleton, Colorado, 미국, 80122
        • AdventHealth Littleton
      • Lone Tree, Colorado, 미국, 80124
        • Rocky Mountain Cancer Centers-Sky Ridge
      • Longmont, Colorado, 미국, 80501
        • Longmont United Hospital
      • Longmont, Colorado, 미국, 80501
        • Rocky Mountain Cancer Centers-Longmont
      • Loveland, Colorado, 미국, 80539
        • Banner North Colorado Medical Center - Loveland Campus
      • Parker, Colorado, 미국, 80138
        • AdventHealth Parker
      • Pueblo, Colorado, 미국, 81004
        • Saint Mary Corwin Medical Center
    • Connecticut
      • Danbury, Connecticut, 미국, 06810
        • Danbury Hospital
      • Norwalk, Connecticut, 미국, 06856
        • Norwalk Hospital
    • Florida
      • Pensacola, Florida, 미국, 32504
        • Sacred Heart Hospital
    • Georgia
      • Atlanta, Georgia, 미국, 30342
        • Northside Hospital
      • Newnan, Georgia, 미국, 30265
        • CTCA at Southeastern Regional Medical Center
    • Hawaii
      • Honolulu, Hawaii, 미국, 96813
        • Queen's Medical Center
      • Honolulu, Hawaii, 미국, 96826
        • Kapiolani Medical Center for Women and Children
    • Idaho
      • Boise, Idaho, 미국, 83706
        • Saint Alphonsus Cancer Care Center-Boise
      • Boise, Idaho, 미국, 83712
        • Saint Luke's Cancer Institute - Boise
      • Caldwell, Idaho, 미국, 83605
        • Saint Alphonsus Cancer Care Center-Caldwell
      • Coeur d'Alene, Idaho, 미국, 83814
        • Kootenai Health - Coeur d'Alene
      • Emmett, Idaho, 미국, 83617
        • Walter Knox Memorial Hospital
      • Fruitland, Idaho, 미국, 83619
        • Saint Luke's Cancer Institute - Fruitland
      • Meridian, Idaho, 미국, 83642
        • Idaho Urologic Institute-Meridian
      • Meridian, Idaho, 미국, 83642
        • Saint Luke's Cancer Institute - Meridian
      • Nampa, Idaho, 미국, 83687
        • Saint Alphonsus Cancer Care Center-Nampa
      • Nampa, Idaho, 미국, 83687
        • Saint Luke's Cancer Institute - Nampa
      • Post Falls, Idaho, 미국, 83854
        • Kootenai Clinic Cancer Services - Post Falls
      • Sandpoint, Idaho, 미국, 83864
        • Kootenai Clinic Cancer Services - Sandpoint
      • Twin Falls, Idaho, 미국, 83301
        • Saint Luke's Cancer Institute - Twin Falls
    • Illinois
      • Alton, Illinois, 미국, 62002
        • OSF Saint Anthony's Health Center
      • Aurora, Illinois, 미국, 60504
        • Rush-Copley Medical Center
      • Bloomington, Illinois, 미국, 61704
        • Illinois CancerCare-Bloomington
      • Canton, Illinois, 미국, 61520
        • Illinois CancerCare-Canton
      • Carbondale, Illinois, 미국, 62902
        • Memorial Hospital of Carbondale
      • Carterville, Illinois, 미국, 62918
        • SIH Cancer Institute
      • Carthage, Illinois, 미국, 62321
        • Illinois CancerCare-Carthage
      • Centralia, Illinois, 미국, 62801
        • Centralia Oncology Clinic
      • Chicago, Illinois, 미국, 60637
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, 미국, 60612
        • John H Stroger Jr Hospital of Cook County
      • Chicago, Illinois, 미국, 60612
        • Rush MD Anderson Cancer Center
      • Danville, Illinois, 미국, 61832
        • Carle at The Riverfront
      • Decatur, Illinois, 미국, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, 미국, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Dixon, Illinois, 미국, 61021
        • Illinois CancerCare-Dixon
      • Effingham, Illinois, 미국, 62401
        • Crossroads Cancer Center
      • Effingham, Illinois, 미국, 62401
        • Carle Physician Group-Effingham
      • Eureka, Illinois, 미국, 61530
        • Illinois CancerCare-Eureka
      • Evanston, Illinois, 미국, 60201
        • NorthShore University HealthSystem-Evanston Hospital
      • Galesburg, Illinois, 미국, 61401
        • Western Illinois Cancer Treatment Center
      • Galesburg, Illinois, 미국, 61401
        • Illinois CancerCare-Galesburg
      • Geneva, Illinois, 미국, 60134
        • Northwestern Medicine Cancer Center Delnor
      • Glenview, Illinois, 미국, 60026
        • NorthShore University HealthSystem-Glenbrook Hospital
      • Harvey, Illinois, 미국, 60426
        • Ingalls Memorial Hospital
      • Highland Park, Illinois, 미국, 60035
        • NorthShore University HealthSystem-Highland Park Hospital
      • Hinsdale, Illinois, 미국, 60521
        • Sudarshan K Sharma MD Limited-Gynecologic Oncology
      • Kewanee, Illinois, 미국, 61443
        • Illinois CancerCare-Kewanee Clinic
      • Macomb, Illinois, 미국, 61455
        • Illinois CancerCare-Macomb
      • Mattoon, Illinois, 미국, 61938
        • Carle Physician Group-Mattoon/Charleston
      • Mount Vernon, Illinois, 미국, 62864
        • SSM Health Good Samaritan
      • New Lenox, Illinois, 미국, 60451
        • UC Comprehensive Cancer Center at Silver Cross
      • O'Fallon, Illinois, 미국, 62269
        • Cancer Care Center of O'Fallon
      • Orland Park, Illinois, 미국, 60462
        • University of Chicago Medicine-Orland Park
      • Ottawa, Illinois, 미국, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Pekin, Illinois, 미국, 61554
        • Illinois CancerCare-Pekin
      • Peoria, Illinois, 미국, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, 미국, 61615
        • Illinois CancerCare-Peoria
      • Peru, Illinois, 미국, 61354
        • Illinois CancerCare-Peru
      • Peru, Illinois, 미국, 61354
        • Valley Radiation Oncology
      • Princeton, Illinois, 미국, 61356
        • Illinois CancerCare-Princeton
      • Springfield, Illinois, 미국, 62702
        • Southern Illinois University School of Medicine
      • Springfield, Illinois, 미국, 62702
        • Springfield Clinic
      • Springfield, Illinois, 미국, 62781
        • Springfield Memorial Hospital
      • Urbana, Illinois, 미국, 61801
        • Carle Cancer Center
      • Urbana, Illinois, 미국, 61801
        • The Carle Foundation Hospital
      • Warrenville, Illinois, 미국, 60555
        • Northwestern Medicine Cancer Center Warrenville
      • Washington, Illinois, 미국, 61571
        • Illinois CancerCare - Washington
      • Yorkville, Illinois, 미국, 60560
        • Rush-Copley Healthcare Center
      • Zion, Illinois, 미국, 60099
        • Midwestern Regional Medical Center
    • Indiana
      • South Bend, Indiana, 미국, 46601
        • Memorial Hospital of South Bend
    • Iowa
      • Ames, Iowa, 미국, 50010
        • Mary Greeley Medical Center
      • Ames, Iowa, 미국, 50010
        • McFarland Clinic - Ames
      • Boone, Iowa, 미국, 50036
        • McFarland Clinic - Boone
      • Cedar Rapids, Iowa, 미국, 52403
        • Mercy Hospital
      • Cedar Rapids, Iowa, 미국, 52403
        • Oncology Associates at Mercy Medical Center
      • Clive, Iowa, 미국, 50325
        • Mercy Cancer Center-West Lakes
      • Clive, Iowa, 미국, 50325
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
      • Council Bluffs, Iowa, 미국, 51503
        • Alegent Health Mercy Hospital
      • Creston, Iowa, 미국, 50801
        • Greater Regional Medical Center
      • Des Moines, Iowa, 미국, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, 미국, 50314
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
      • Fort Dodge, Iowa, 미국, 50501
        • McFarland Clinic - Trinity Cancer Center
      • Iowa City, Iowa, 미국, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
      • Jefferson, Iowa, 미국, 50129
        • McFarland Clinic - Jefferson
      • Marshalltown, Iowa, 미국, 50158
        • McFarland Clinic - Marshalltown
      • West Des Moines, Iowa, 미국, 50266
        • Mercy Medical Center-West Lakes
    • Kansas
      • Garden City, Kansas, 미국, 67846
        • Central Care Cancer Center - Garden City
      • Great Bend, Kansas, 미국, 67530
        • Central Care Cancer Center - Great Bend
    • Kentucky
      • Bardstown, Kentucky, 미국, 40004
        • CommonSpirit Saint Joseph Hospital - Bardstown
      • Corbin, Kentucky, 미국, 40701
        • Commonwealth Cancer Center-Corbin
      • Lexington, Kentucky, 미국, 40504
        • Saint Joseph Radiation Oncology Resource Center
      • Lexington, Kentucky, 미국, 40509
        • CommonSpirit Saint Joseph Medical Center - East Lexington
      • London, Kentucky, 미국, 40741
        • CommonSpirit Saint Joseph Hospital London
      • Louisville, Kentucky, 미국, 40202
        • Jewish Hospital
      • Louisville, Kentucky, 미국, 40245
        • UofL Health Medical Center Northeast
      • Louisville, Kentucky, 미국, 40215
        • Saints Mary and Elizabeth Hospital
      • Shepherdsville, Kentucky, 미국, 40165
        • Jewish Hospital Medical Center South
    • Louisiana
      • Baton Rouge, Louisiana, 미국, 70817
        • Our Lady of the Lake Medical Oncology
    • Maine
      • Augusta, Maine, 미국, 04330
        • Harold Alfond Center for Cancer Care
      • Brewer, Maine, 미국, 04412
        • Lafayette Family Cancer Center-EMMC
      • Scarborough, Maine, 미국, 04074
        • MaineHealth Maine Medical Center- Scarborough
    • Maryland
      • Baltimore, Maryland, 미국, 21204
        • Greater Baltimore Medical Center
      • Bethesda, Maryland, 미국, 20892
        • National Institutes of Health Clinical Center
    • Michigan
      • Ann Arbor, Michigan, 미국, 48109
        • University of Michigan Rogel Cancer Center
      • Dearborn, Michigan, 미국, 48124
        • Corewell Health Dearborn Hospital
      • Royal Oak, Michigan, 미국, 48073
        • Corewell Health William Beaumont University Hospital
      • Troy, Michigan, 미국, 48085
        • Corewell Health Beaumont Troy Hospital
    • Minnesota
      • Burnsville, Minnesota, 미국, 55337
        • Fairview Ridges Hospital
      • Burnsville, Minnesota, 미국, 55337
        • Minnesota Oncology - Burnsville
      • Cambridge, Minnesota, 미국, 55008
        • Cambridge Medical Center
      • Coon Rapids, Minnesota, 미국, 55433
        • Mercy Hospital
      • Edina, Minnesota, 미국, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, 미국, 55432
        • Unity Hospital
      • Maple Grove, Minnesota, 미국, 55369
        • Fairview Clinics and Surgery Center Maple Grove
      • Maplewood, Minnesota, 미국, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, 미국, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, 미국, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, 미국, 55407
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, 미국, 55454
        • Health Partners Inc
      • Minneapolis, Minnesota, 미국, 55455
        • University of Minnesota/Masonic Cancer Center
      • Monticello, Minnesota, 미국, 55362
        • Monticello Cancer Center
      • New Ulm, Minnesota, 미국, 56073
        • New Ulm Medical Center
      • Princeton, Minnesota, 미국, 55371
        • Fairview Northland Medical Center
      • Robbinsdale, Minnesota, 미국, 55422
        • North Memorial Medical Health Center
      • Saint Louis Park, Minnesota, 미국, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, 미국, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, 미국, 55102
        • United Hospital
      • Shakopee, Minnesota, 미국, 55379
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, 미국, 55082
        • Lakeview Hospital
      • Waconia, Minnesota, 미국, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, 미국, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, 미국, 55125
        • Minnesota Oncology Hematology PA-Woodbury
      • Wyoming, Minnesota, 미국, 55092
        • Fairview Lakes Medical Center
    • Missouri
      • Ballwin, Missouri, 미국, 63011
        • Mercy Oncology and Hematology - Clayton-Clarkson
      • Bolivar, Missouri, 미국, 65613
        • Central Care Cancer Center - Bolivar
      • Cape Girardeau, Missouri, 미국, 63703
        • Saint Francis Medical Center
      • Cape Girardeau, Missouri, 미국, 63703
        • Mercy Cancer Center - Cape Girardeau
      • Farmington, Missouri, 미국, 63640
        • Parkland Health Center - Farmington
      • Jefferson City, Missouri, 미국, 65109
        • MU Health Care Goldschmidt Cancer Center
      • Joplin, Missouri, 미국, 64804
        • Freeman Health System
      • Joplin, Missouri, 미국, 64804
        • Mercy Hospital Joplin
      • Rolla, Missouri, 미국, 65401
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Rolla, Missouri, 미국, 65401
        • Phelps Health Delbert Day Cancer Institute
      • Saint Joseph, Missouri, 미국, 64506
        • Heartland Regional Medical Center
      • Sainte Genevieve, Missouri, 미국, 63670
        • Sainte Genevieve County Memorial Hospital
      • Springfield, Missouri, 미국, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, 미국, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, 미국, 63110
        • Washington University School of Medicine
      • St Louis, Missouri, 미국, 63131
        • Missouri Baptist Medical Center
      • St Louis, Missouri, 미국, 63109
        • Mercy Infusion Center - Chippewa
      • St Louis, Missouri, 미국, 63141
        • Mercy Hospital Saint Louis
      • St Louis, Missouri, 미국, 63128
        • Mercy Hospital South
      • Sullivan, Missouri, 미국, 63080
        • Missouri Baptist Sullivan Hospital
      • Washington, Missouri, 미국, 63090
        • Mercy Hospital Washington
    • Montana
      • Anaconda, Montana, 미국, 59711
        • Community Hospital of Anaconda
      • Billings, Montana, 미국, 59101
        • Billings Clinic Cancer Center
      • Bozeman, Montana, 미국, 59715
        • Bozeman Health Deaconess Hospital
      • Great Falls, Montana, 미국, 59405
        • Great Falls Clinic
      • Great Falls, Montana, 미국, 59405
        • Benefis Sletten Cancer Institute
      • Kalispell, Montana, 미국, 59901
        • Logan Health Medical Center
      • Missoula, Montana, 미국, 59802
        • Saint Patrick Hospital - Community Hospital
      • Missoula, Montana, 미국, 59804
        • Community Medical Center
    • Nebraska
      • Grand Island, Nebraska, 미국, 68803
        • Nebraska Cancer Specialists/Oncology Hematology West PC
      • Kearney, Nebraska, 미국, 68847
        • CHI Health Good Samaritan
      • Lincoln, Nebraska, 미국, 68510
        • Saint Elizabeth Regional Medical Center
      • Lincoln, Nebraska, 미국, 68516
        • Cancer Partners of Nebraska
      • Omaha, Nebraska, 미국, 68114
        • Nebraska Methodist Hospital
      • Omaha, Nebraska, 미국, 68198
        • University of Nebraska Medical Center
      • Omaha, Nebraska, 미국, 68124
        • Alegent Health Bergan Mercy Medical Center
      • Omaha, Nebraska, 미국, 68122
        • Alegent Health Immanuel Medical Center
      • Omaha, Nebraska, 미국, 68130
        • Alegent Health Lakeside Hospital
      • Papillion, Nebraska, 미국, 68046
        • Midlands Community Hospital
    • Nevada
      • Las Vegas, Nevada, 미국, 89106
        • Women's Cancer Center of Nevada
    • New Jersey
      • Neptune City, New Jersey, 미국, 07753
        • Jersey Shore Medical Center
    • New Mexico
      • Albuquerque, New Mexico, 미국, 87106
        • University of New Mexico Cancer Center
      • Las Cruces, New Mexico, 미국, 88011
        • Memorial Medical Center-Las Cruces
      • Rio Rancho, New Mexico, 미국, 87124
        • Presbyterian Rust Medical Center/Jorgensen Cancer Center
    • New York
      • Bay Shore, New York, 미국, 11706
        • Northwell Health Imbert Cancer Center
      • Brightwaters, New York, 미국, 11718
        • Island Gynecologic Oncology
      • Buffalo, New York, 미국, 14263
        • Roswell Park Cancer Institute
      • Lake Success, New York, 미국, 11042
        • Northwell Health/Center for Advanced Medicine
      • Syracuse, New York, 미국, 13210
        • State University of New York Upstate Medical University
      • White Plains, New York, 미국, 10601
        • Dickstein Cancer Treatment Center
    • North Carolina
      • Clinton, North Carolina, 미국, 28328
        • Southeastern Medical Oncology Center-Clinton
      • Goldsboro, North Carolina, 미국, 27534
        • Southeastern Medical Oncology Center-Goldsboro
      • Jacksonville, North Carolina, 미국, 28546
        • Southeastern Medical Oncology Center-Jacksonville
    • Ohio
      • Akron, Ohio, 미국, 44304
        • Summa Health System - Akron Campus
      • Alliance, Ohio, 미국, 44601
        • Aultman Alliance Community Hospital
      • Beachwood, Ohio, 미국, 44122
        • UHHS-Chagrin Highlands Medical Center
      • Belpre, Ohio, 미국, 45714
        • Strecker Cancer Center-Belpre
      • Canton, Ohio, 미국, 44710
        • Aultman Health Foundation
      • Centerville, Ohio, 미국, 45459
        • Miami Valley Hospital South
      • Chardon, Ohio, 미국, 44024
        • Geauga Hospital
      • Chillicothe, Ohio, 미국, 45601
        • Adena Regional Medical Center
      • Cincinnati, Ohio, 미국, 45220
        • Good Samaritan Hospital - Cincinnati
      • Cincinnati, Ohio, 미국, 45242
        • Bethesda North Hospital
      • Cincinnati, Ohio, 미국, 45247
        • TriHealth Cancer Institute-Westside
      • Cincinnati, Ohio, 미국, 45255
        • TriHealth Cancer Institute-Anderson
      • Cleveland, Ohio, 미국, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, 미국, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, 미국, 44111
        • Cleveland Clinic Cancer Center/Fairview Hospital
      • Columbus, Ohio, 미국, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, 미국, 43210
        • Ohio State University Comprehensive Cancer Center
      • Columbus, Ohio, 미국, 43219
        • The Mark H Zangmeister Center
      • Columbus, Ohio, 미국, 43214
        • Columbus Oncology and Hematology Associates Inc
      • Columbus, Ohio, 미국, 43228
        • Doctors Hospital
      • Columbus, Ohio, 미국, 43213
        • Mount Carmel East Hospital
      • Columbus, Ohio, 미국, 43215
        • Grant Medical Center
      • Columbus, Ohio, 미국, 43222
        • Mount Carmel Health Center West
      • Dayton, Ohio, 미국, 45409
        • Miami Valley Hospital
      • Delaware, Ohio, 미국, 43015
        • Delaware Health Center-Grady Cancer Center
      • Delaware, Ohio, 미국, 43015
        • Grady Memorial Hospital
      • Dublin, Ohio, 미국, 43016
        • Dublin Methodist Hospital
      • Gahanna, Ohio, 미국, 43230
        • Central Ohio Breast and Endocrine Surgery
      • Grove City, Ohio, 미국, 43123
        • Mount Carmel Grove City Hospital
      • Lancaster, Ohio, 미국, 43130
        • Fairfield Medical Center
      • Lima, Ohio, 미국, 45801
        • Saint Rita's Medical Center
      • Mansfield, Ohio, 미국, 44903
        • OhioHealth Mansfield Hospital
      • Marietta, Ohio, 미국, 45750
        • Marietta Memorial Hospital
      • Marion, Ohio, 미국, 43302
        • OhioHealth Marion General Hospital
      • Mayfield Heights, Ohio, 미국, 44124
        • Hillcrest Hospital Cancer Center
      • Mentor, Ohio, 미국, 44060
        • UH Seidman Cancer Center at Lake Health Mentor Campus
      • Mount Vernon, Ohio, 미국, 43050
        • Knox Community Hospital
      • Newark, Ohio, 미국, 43055
        • Licking Memorial Hospital
      • Newark, Ohio, 미국, 43055
        • Newark Radiation Oncology
      • Perrysburg, Ohio, 미국, 43551
        • Mercy Health - Perrysburg Hospital
      • Portsmouth, Ohio, 미국, 45662
        • Southern Ohio Medical Center
      • Toledo, Ohio, 미국, 43623
        • Mercy Health - Saint Anne Hospital
      • Toledo, Ohio, 미국, 43608
        • Mercy Health - Saint Vincent Hospital
      • Wadsworth, Ohio, 미국, 44281
        • University Hospitals Sharon Health Center
      • Westerville, Ohio, 미국, 43081
        • Saint Ann's Hospital
      • Westlake, Ohio, 미국, 44145
        • UH Seidman Cancer Center at Saint John Medical Center
      • Zanesville, Ohio, 미국, 43701
        • Genesis Healthcare System Cancer Care Center
    • Oklahoma
      • Lawton, Oklahoma, 미국, 73505
        • Cancer Centers of Southwest Oklahoma Research
      • Oklahoma City, Oklahoma, 미국, 73104
        • University of Oklahoma Health Sciences Center
      • Oklahoma City, Oklahoma, 미국, 73120
        • Mercy Hospital Oklahoma City
      • Tulsa, Oklahoma, 미국, 74146
        • Oklahoma Cancer Specialists and Research Institute-Tulsa
    • Oregon
      • Baker City, Oregon, 미국, 97814
        • Saint Alphonsus Cancer Care Center-Baker City
      • Bend, Oregon, 미국, 97701
        • Saint Charles Health System
      • Clackamas, Oregon, 미국, 97015
        • Clackamas Radiation Oncology Center
      • Clackamas, Oregon, 미국, 97015
        • Providence Cancer Institute Clackamas Clinic
      • Coos Bay, Oregon, 미국, 97420
        • Bay Area Hospital
      • Newberg, Oregon, 미국, 97132
        • Providence Newberg Medical Center
      • Ontario, Oregon, 미국, 97914
        • Saint Alphonsus Cancer Care Center-Ontario
      • Portland, Oregon, 미국, 97210
        • Legacy Good Samaritan Hospital and Medical Center
      • Portland, Oregon, 미국, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, 미국, 97225
        • Providence Saint Vincent Medical Center
      • Redmond, Oregon, 미국, 97756
        • Saint Charles Health System-Redmond
      • Tualatin, Oregon, 미국, 97062
        • Legacy Meridian Park Hospital
    • Pennsylvania
      • Butler, Pennsylvania, 미국, 16001
        • UPMC Hillman Cancer Center at Butler Health System
      • Erie, Pennsylvania, 미국, 16505
        • UPMC Hillman Cancer Center Erie
      • Paoli, Pennsylvania, 미국, 19301
        • Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, 미국, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, 미국, 19114
        • Jefferson Torresdale Hospital
      • Pittsburgh, Pennsylvania, 미국, 15224
        • West Penn Hospital
      • Pittsburgh, Pennsylvania, 미국, 15232
        • UPMC Hillman Cancer Center
      • Pittsburgh, Pennsylvania, 미국, 15213
        • UPMC-Magee Womens Hospital
      • Pittsburgh, Pennsylvania, 미국, 15237
        • UPMC-Passavant Hospital
      • Willow Grove, Pennsylvania, 미국, 19090
        • Asplundh Cancer Pavilion
      • Wynnewood, Pennsylvania, 미국, 19096
        • Lankenau Medical Center
    • Rhode Island
      • Providence, Rhode Island, 미국, 02905
        • Women and Infants Hospital
    • South Carolina
      • Charleston, South Carolina, 미국, 29425
        • Medical University of South Carolina
      • Greenville, South Carolina, 미국, 29607
        • Saint Francis Cancer Center
      • Greenville, South Carolina, 미국, 29601
        • Saint Francis Hospital
    • South Dakota
      • Rapid City, South Dakota, 미국, 57701
        • Rapid City Regional Hospital
    • Tennessee
      • Bristol, Tennessee, 미국, 37620
        • Bristol Regional Medical Center
      • Kingsport, Tennessee, 미국, 37660
        • Ballad Health Cancer Care - Kingsport
      • Kingsport, Tennessee, 미국, 37660
        • Wellmont Holston Valley Hospital and Medical Center
      • Knoxville, Tennessee, 미국, 37916
        • Covenant Health Cancer Centers
      • Knoxville, Tennessee, 미국, 37932
        • Covenant Health Cancer Centers - West
      • Nashville, Tennessee, 미국, 37232
        • Vanderbilt University/Ingram Cancer Center
      • Nashville, Tennessee, 미국, 37204
        • Vanderbilt Breast Center at One Hundred Oaks
    • Texas
      • Bryan, Texas, 미국, 77802
        • Saint Joseph Regional Cancer Center
      • Dallas, Texas, 미국, 75235
        • Parkland Memorial Hospital
      • Dallas, Texas, 미국, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Houston, Texas, 미국, 77030
        • Houston Methodist Hospital
      • Houston, Texas, 미국, 77070
        • Methodist Willowbrook Hospital
      • Houston, Texas, 미국, 77094
        • Houston Methodist West Hospital
      • Sugar Land, Texas, 미국, 77479
        • Houston Methodist Sugar Land Hospital
      • The Woodlands, Texas, 미국, 77385
        • Houston Methodist The Woodlands Hospital
    • Virginia
      • Bristol, Virginia, 미국, 24201
        • Ballad Health Cancer Care - Bristol
      • Norton, Virginia, 미국, 24273
        • Ballad Health Cancer Care - Norton
    • Washington
      • Aberdeen, Washington, 미국, 98520
        • Providence Regional Cancer System-Aberdeen
      • Bellingham, Washington, 미국, 98225
        • PeaceHealth Saint Joseph Medical Center
      • Burien, Washington, 미국, 98166
        • Saint Anne Hospital
      • Centralia, Washington, 미국, 98531
        • Providence Regional Cancer System-Centralia
      • Edmonds, Washington, 미국, 98026
        • Swedish Cancer Institute-Edmonds
      • Enumclaw, Washington, 미국, 98022
        • Saint Elizabeth Hospital
      • Everett, Washington, 미국, 98201
        • Providence Regional Cancer Partnership
      • Federal Way, Washington, 미국, 98003
        • Saint Francis Hospital
      • Issaquah, Washington, 미국, 98029
        • Swedish Cancer Institute-Issaquah
      • Kennewick, Washington, 미국, 99336
        • Kadlec Clinic Hematology and Oncology
      • Lacey, Washington, 미국, 98503
        • Providence Regional Cancer System-Lacey
      • Lakewood, Washington, 미국, 98499
        • Saint Clare Hospital
      • Longview, Washington, 미국, 98632
        • PeaceHealth Saint John Medical Center
      • Port Townsend, Washington, 미국, 98368
        • Jefferson Healthcare
      • Seattle, Washington, 미국, 98107
        • Swedish Medical Center-Ballard Campus
      • Seattle, Washington, 미국, 98122
        • Swedish Medical Center-First Hill
      • Seattle, Washington, 미국, 98104
        • Pacific Gynecology Specialists
      • Seattle, Washington, 미국, 98122-5711
        • Swedish Medical Center-Cherry Hill
      • Sedro-Woolley, Washington, 미국, 98284
        • PeaceHealth United General Medical Center
      • Shelton, Washington, 미국, 98584
        • Providence Regional Cancer System-Shelton
      • Silverdale, Washington, 미국, 98383
        • Saint Joseph Medical Center Hematology and Oncology - Silverdale
      • Tacoma, Washington, 미국, 98405
        • Franciscan Research Center-Northwest Medical Plaza
      • Vancouver, Washington, 미국, 98686
        • Legacy Salmon Creek Hospital
      • Vancouver, Washington, 미국, 98664
        • PeaceHealth Southwest Medical Center
      • Walla Walla, Washington, 미국, 99362
        • Providence Saint Mary Regional Cancer Center
      • Yelm, Washington, 미국, 98597
        • Providence Regional Cancer System-Yelm
    • West Virginia
      • Charleston, West Virginia, 미국, 25304
        • Vandalia Health/CAMC Institute for Academic Medicine
    • Wisconsin
      • Green Bay, Wisconsin, 미국, 54301
        • Saint Vincent Hospital Cancer Center Green Bay
      • Green Bay, Wisconsin, 미국, 54303
        • Saint Vincent Hospital Cancer Center at Saint Mary's
      • La Crosse, Wisconsin, 미국, 54601
        • Gundersen Lutheran Medical Center
      • Milwaukee, Wisconsin, 미국, 53226
        • Medical College of Wisconsin
      • Mukwonago, Wisconsin, 미국, 53149
        • ProHealth D N Greenwald Center
      • New Richmond, Wisconsin, 미국, 54017
        • Cancer Center of Western Wisconsin
      • Oconomowoc, Wisconsin, 미국, 53066
        • ProHealth Oconomowoc Memorial Hospital
      • Oconto Falls, Wisconsin, 미국, 54154
        • Saint Vincent Hospital Cancer Center at Oconto Falls
      • Sturgeon Bay, Wisconsin, 미국, 54235-1495
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
      • Waukesha, Wisconsin, 미국, 53188
        • UW Cancer Center at ProHealth Care
      • Waukesha, Wisconsin, 미국, 53188
        • ProHealth Waukesha Memorial Hospital
    • Wyoming
      • Cody, Wyoming, 미국, 82414
        • Billings Clinic-Cody
      • Sheridan, Wyoming, 미국, 82801
        • Welch Cancer Center
  • 푸에르토 리코
      • Bayamón, 푸에르토 리코, 00959-5060
        • Cancer Center-Metro Medical Center Bayamon
      • Caguas, 푸에르토 리코, 00726
        • HIMA San Pablo Oncologic Hospital
      • Manati, 푸에르토 리코, 00674
        • Doctors Cancer Center
      • Ponce, 푸에르토 리코, 00716
        • Instituto Oncologia Moderna Ponce
      • San Juan, 푸에르토 리코, 00917
        • San Juan Community Oncology Group
      • San Juan, 푸에르토 리코, 00927
        • Centro Comprensivo de Cancer de UPR
      • San Juan, 푸에르토 리코, 00936
        • San Juan City Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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.
의약품: Paclitaxel

Given IV

다른 이름들:
  • 탁솔
  • 안자탁스
  • 아소탁스
  • 브리스타솔
  • 프락셀
  • 탁솔 콘첸트라트
절차: Computed Tomography

Undergo CT

다른 이름들:
  • CT
  • 고양이
  • 고양이 스캔
  • 컴퓨터 축 단층 촬영
  • 전산화 단층 촬영
  • CT 스캔
  • 단층 촬영
  • 컴퓨터 축 단층 촬영(시술)
  • 컴퓨터 단층촬영(CT) 스캔
  • 진단 CAT 스캔
  • 진단 CAT 스캔 서비스 유형
절차: Magnetic Resonance Imaging

Undergo MRI

다른 이름들:
  • MRI
  • 자기 공명
  • 자기공명영상 스캔
  • 의료영상, 자기공명 / 핵자기공명
  • 씨
  • MR 이미징
  • MRI 검사
  • NMR 이미징
  • NMRI
  • 핵자기공명영상
  • 자기공명영상(MRI)
  • SMRI
  • 자기공명영상(시술)
  • 구조적 MRI
절차: Echocardiography Test

Undergo ECHO

다른 이름들:
  • 심초음파
  • EC
절차: Multigated Acquisition Scan

Undergo MUGA

다른 이름들:
  • 혈액 풀 스캔
  • 평형 방사성핵종 혈관조영술
  • 게이티드 혈액 풀 이미징
  • 무가
  • 방사성핵종 뇌실조영술
  • RNVG
  • SYMA 스캐닝
  • 동기화된 다중 게이트 수집 스캐닝
  • 무가 스캔
  • 다중 게이트 획득 스캔
  • 방사성핵종 뇌실도 스캔
  • 게이트 하트 풀 스캔
  • RNV 스캔
절차: Biospecimen Collection

Undergo collection of blood

다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집
의약품: Pegylated Liposomal Doxorubicin Hydrochloride

Given IV

다른 이름들:
  • ATI-0918
  • Caelyx
  • 독실
  • 독실렌
  • 독소루비신 HCl 리포좀
  • 두오메이수
  • 에바셋
  • 리포독스
  • 리포솜 아드리아마이신
  • 리포솜 캡슐화된 독소루비신
  • 페길화된 독소루비신 HCl 리포좀
  • S-리포좀 독소루비신
  • 스텔스 리포솜 독소루비신
  • TLC D-99
  • Dox-SL
  • 독소루비신 HCl 리포솜
  • 독소루비신 염산염 리포솜
  • 리포독스 50
  • 리포솜 독소루비신 염산염
  • 페길화된 리포솜 독소루비신
  • 리포솜 독소루비신
의약품: Topotecan Hydrochloride

Given IV

다른 이름들:
  • 하이캄틴
  • 히캄파민
  • SKF S-104864-A
  • 토포테칸 HCl
  • 토포테칸 염산염(경구)
  • 포탁타솔
  • 에보토핀
  • 토포텍
  • 노기테칸 염산염
  • SKF S 104864 A
  • SKF S104864A
절차: Computed Tomography with Contrast

Undergo CT with contrast

다른 이름들:
  • 조영 증강 컴퓨터 단층 촬영
  • 대비 강화 CT 스캔
  • 대비가 있는 CT 스캔
  • 대비가 있는 CT
실험적: 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.
절차: Computed Tomography

Undergo CT

다른 이름들:
  • CT
  • 고양이
  • 고양이 스캔
  • 컴퓨터 축 단층 촬영
  • 전산화 단층 촬영
  • CT 스캔
  • 단층 촬영
  • 컴퓨터 축 단층 촬영(시술)
  • 컴퓨터 단층촬영(CT) 스캔
  • 진단 CAT 스캔
  • 진단 CAT 스캔 서비스 유형
절차: Magnetic Resonance Imaging

Undergo MRI

다른 이름들:
  • MRI
  • 자기 공명
  • 자기공명영상 스캔
  • 의료영상, 자기공명 / 핵자기공명
  • 씨
  • MR 이미징
  • MRI 검사
  • NMR 이미징
  • NMRI
  • 핵자기공명영상
  • 자기공명영상(MRI)
  • SMRI
  • 자기공명영상(시술)
  • 구조적 MRI
절차: Echocardiography Test

Undergo ECHO

다른 이름들:
  • 심초음파
  • EC
절차: Multigated Acquisition Scan

Undergo MUGA

다른 이름들:
  • 혈액 풀 스캔
  • 평형 방사성핵종 혈관조영술
  • 게이티드 혈액 풀 이미징
  • 무가
  • 방사성핵종 뇌실조영술
  • RNVG
  • SYMA 스캐닝
  • 동기화된 다중 게이트 수집 스캐닝
  • 무가 스캔
  • 다중 게이트 획득 스캔
  • 방사성핵종 뇌실도 스캔
  • 게이트 하트 풀 스캔
  • RNV 스캔
절차: Biospecimen Collection

Undergo collection of blood

다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집
의약품: Cediranib Maleate

Given PO

다른 이름들:
  • AZD2171
  • AZD2171 말레이트
  • 레센틴
의약품: Olaparib

Given PO

다른 이름들:
  • 린파자
  • AZD2281
  • AZD-2281
  • KU-0059436
  • PARP 억제제 AZD2281
  • KU0059436
  • 올라닙
  • 올라파릭스
  • 쿠 0059436
절차: Computed Tomography with Contrast

Undergo CT with contrast

다른 이름들:
  • 조영 증강 컴퓨터 단층 촬영
  • 대비 강화 CT 스캔
  • 대비가 있는 CT 스캔
  • 대비가 있는 CT
생물학적: Durvalumab

Given IV

다른 이름들:
  • 임핀지
  • Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, 이합체
  • 메디-4736
  • 메디4736
실험적: 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.
절차: Computed Tomography

Undergo CT

다른 이름들:
  • CT
  • 고양이
  • 고양이 스캔
  • 컴퓨터 축 단층 촬영
  • 전산화 단층 촬영
  • CT 스캔
  • 단층 촬영
  • 컴퓨터 축 단층 촬영(시술)
  • 컴퓨터 단층촬영(CT) 스캔
  • 진단 CAT 스캔
  • 진단 CAT 스캔 서비스 유형
절차: Magnetic Resonance Imaging

Undergo MRI

다른 이름들:
  • MRI
  • 자기 공명
  • 자기공명영상 스캔
  • 의료영상, 자기공명 / 핵자기공명
  • 씨
  • MR 이미징
  • MRI 검사
  • NMR 이미징
  • NMRI
  • 핵자기공명영상
  • 자기공명영상(MRI)
  • SMRI
  • 자기공명영상(시술)
  • 구조적 MRI
절차: Echocardiography Test

Undergo ECHO

다른 이름들:
  • 심초음파
  • EC
절차: Multigated Acquisition Scan

Undergo MUGA

다른 이름들:
  • 혈액 풀 스캔
  • 평형 방사성핵종 혈관조영술
  • 게이티드 혈액 풀 이미징
  • 무가
  • 방사성핵종 뇌실조영술
  • RNVG
  • SYMA 스캐닝
  • 동기화된 다중 게이트 수집 스캐닝
  • 무가 스캔
  • 다중 게이트 획득 스캔
  • 방사성핵종 뇌실도 스캔
  • 게이트 하트 풀 스캔
  • RNV 스캔
절차: Biospecimen Collection

Undergo collection of blood

다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집
의약품: Cediranib Maleate

Given PO

다른 이름들:
  • AZD2171
  • AZD2171 말레이트
  • 레센틴
절차: Computed Tomography with Contrast

Undergo CT with contrast

다른 이름들:
  • 조영 증강 컴퓨터 단층 촬영
  • 대비 강화 CT 스캔
  • 대비가 있는 CT 스캔
  • 대비가 있는 CT
생물학적: Durvalumab

Given IV

다른 이름들:
  • 임핀지
  • Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, 이합체
  • 메디-4736
  • 메디4736
실험적: 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.
절차: Computed Tomography

Undergo CT

다른 이름들:
  • CT
  • 고양이
  • 고양이 스캔
  • 컴퓨터 축 단층 촬영
  • 전산화 단층 촬영
  • CT 스캔
  • 단층 촬영
  • 컴퓨터 축 단층 촬영(시술)
  • 컴퓨터 단층촬영(CT) 스캔
  • 진단 CAT 스캔
  • 진단 CAT 스캔 서비스 유형
절차: Magnetic Resonance Imaging

Undergo MRI

다른 이름들:
  • MRI
  • 자기 공명
  • 자기공명영상 스캔
  • 의료영상, 자기공명 / 핵자기공명
  • 씨
  • MR 이미징
  • MRI 검사
  • NMR 이미징
  • NMRI
  • 핵자기공명영상
  • 자기공명영상(MRI)
  • SMRI
  • 자기공명영상(시술)
  • 구조적 MRI
절차: Echocardiography Test

Undergo ECHO

다른 이름들:
  • 심초음파
  • EC
절차: Biospecimen Collection

Undergo collection of blood

다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집
의약품: Cediranib Maleate

Given PO

다른 이름들:
  • AZD2171
  • AZD2171 말레이트
  • 레센틴
의약품: Olaparib

Given PO

다른 이름들:
  • 린파자
  • AZD2281
  • AZD-2281
  • KU-0059436
  • PARP 억제제 AZD2281
  • KU0059436
  • 올라닙
  • 올라파릭스
  • 쿠 0059436
절차: Computed Tomography with Contrast

Undergo CT with contrast

다른 이름들:
  • 조영 증강 컴퓨터 단층 촬영
  • 대비 강화 CT 스캔
  • 대비가 있는 CT 스캔
  • 대비가 있는 CT

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Progression Free Survival
기간: 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).

2차 결과 측정

결과 측정
측정값 설명
기간
Objective Response Rate
기간: 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
기간: 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
기간: 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
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

National Cancer Institute (NCI)

협력자

NRG Oncology

수사관

  • 수석 연구원: Jung-min Lee, NRG Oncology

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 6월 10일

기본 완료 (실제)

2023년 1월 26일

연구 완료 (추정된)

2027년 6월 25일

연구 등록 날짜

최초 제출

2021년 2월 4일

QC 기준을 충족하는 최초 제출

2021년 2월 4일

처음 게시됨 (실제)

2021년 2월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 21일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • NCI-2021-00615
  • U10CA180868 (미국 NIH 보조금/계약)
  • NCI-2021-00615 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
  • NRG-GY023 (기타 식별자: CTEP)
  • NRG-GY023 (기타 식별자: NRG Oncology)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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