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진행성 난소암 환자에서 화학요법과 베바시주맙을 병용한 뒤 더발루맙, 베바시주맙, 올라파립 유지 치료 (DUO-O)

2026년 6월 8일 업데이트: AstraZeneca

새로 진단된 진행성 난소암 환자(DUO-O)에서 Durvalumab을 화학요법 및 Bevacizumab과 병용한 후 Durvalumab, Bevacizumab 및 Olaparib을 유지 관리하는 III상 무작위, 이중 맹검, 위약 대조, 다기관 연구.

이것은 표준 치료 백금 기반 화학요법 및 베바시주맙과 병용한 뒤 두르발루맙 및 베바시주맙 유지요법 또는 두르발루맙, 베바시주맙 및 올라파립과 병용한 두르발루맙의 효능 및 안전성을 평가하기 위한 3상 무작위, 이중 맹검, 다기관 연구입니다. 진행성 난소암 진단을 받았습니다.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

적격 환자는 새로 진단되고 조직학적으로 확인된 진행성(Fédération Internationale de Gynécologie et d'Obstétrique [FIGO] Stage III-IV) 난소, 원발성 복막암 및/또는 난관암 환자입니다. 모든 환자는 진단 후 즉각적인 선행 1차 수술로 수행할 수 있거나 백금 기반 신보강 화학요법을 시작한 후에 수행할 수 있는 세포 감소 수술의 대상자여야 합니다. 모든 환자는 베바시주맙과 병용하여 1차 백금 기반 화학요법을 시작할 자격이 있어야 합니다.

이 연구의 목적은 표준 치료(SoC) 백금 기반 화학 요법과 베바시주맙에 이어 베바시주맙을 단독 요법으로, 또는 더발루맙과 병용하거나 더발루맙과 올라파립과 병용하는 것의 효능과 안전성을 평가하는 것입니다. 따라서 이 연구는 어떤 조합이 암이 재발하거나 악화되지 않고 환자가 더 오래 살 수 있는지 확인하는 것을 목표로 합니다. 이 연구는 또한 어떤 조합이 환자를 더 오래 살게 하고 치료와 암이 삶의 질에 어떤 영향을 미치는지 알아보고 있습니다.

연구 유형

중재적

등록 (실제)

1407

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 대한민국
      • Goyang-si, 대한민국, 10408
        • Research Site
      • Seongnam-si, 대한민국, 13620
        • Research Site
      • Seoul, 대한민국, 03080
        • Research Site
      • Seoul, 대한민국, 03722
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      • Seoul, 대한민국, 06351
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      • Suwon, 대한민국, 16499
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  • 덴마크
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      • Aarhus N, 덴마크, 8200
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      • Odense, 덴마크, 5000
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  • 독일
      • Bad Homburg, 독일, 61352
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      • Berlin, 독일, 10117
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      • Freiburg im Breisgau, 독일, 79106
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      • Hamburg, 독일, 22457
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      • Kassel, 독일, 34125
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      • Leipzig, 독일, 04103
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      • Ludwigsburg, 독일, 71640
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      • Lübeck, 독일, 23538
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      • Mainz, 독일, 55131
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      • München, 독일, 81377
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      • Offenbach, 독일, 63069
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      • Oldenburg, 독일, 26133
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      • Rosenheim, 독일, 83022
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      • Rostock, 독일, 18057
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      • Saalfeld, 독일, 07318
        • Research Site
      • Schweinfurt, 독일, 97422
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      • Tübingen, 독일, 72016
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      • Ulm, 독일, 89075
        • Research Site
      • Worms, 독일, 67550
        • Research Site
  • 루마니아
      • Floreşti, 루마니아, 407280
        • Research Site
  • 미국
    • California
      • Foothill Ranch, California, 미국, 92610
        • Research Site
      • Los Angeles, California, 미국, 90095
        • Research Site
      • Orange, California, 미국, 92868-3298
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      • San Francisco, California, 미국, 94158
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    • Florida
      • Tampa, Florida, 미국, 33612
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    • Georgia
      • Augusta, Georgia, 미국, 30912
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    • Illinois
      • Hinsdale, Illinois, 미국, 60521
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    • Indiana
      • Indianapolis, Indiana, 미국, 46202
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    • Maryland
      • Towson, Maryland, 미국, 21204
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    • Michigan
      • Detroit, Michigan, 미국, 48202
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    • Missouri
      • Springfield, Missouri, 미국, 65807
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    • New Jersey
      • Middletown, New Jersey, 미국, 07748
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      • Montvale, New Jersey, 미국, 07645
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    • New York
      • Albany, New York, 미국, 12208
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      • New York, New York, 미국, 10065
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      • Uniondale, New York, 미국, 11553
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    • North Carolina
      • Durham, North Carolina, 미국, 27710
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    • Ohio
      • Cleveland, Ohio, 미국, 44195
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      • Dayton, Ohio, 미국, 45429
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      • Hilliard, Ohio, 미국, 43026
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    • Oklahoma
      • Tulsa, Oklahoma, 미국, 74134
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    • Pennsylvania
      • Lancaster, Pennsylvania, 미국, 17601
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      • Philadelphia, Pennsylvania, 미국, 19104
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      • Philadelphia, Pennsylvania, 미국, 19107-5097
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      • Pittsburgh, Pennsylvania, 미국, 15224
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    • Utah
      • Salt Lake City, Utah, 미국, 84112
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  • 벨기에
      • Aalst, 벨기에, 9300
        • Research Site
      • Leuven, 벨기에, 3000
        • Research Site
      • Namur, 벨기에, 5000
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      • Ostend, 벨기에, 8400
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      • Sint-Niklaas, 벨기에, 9100
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  • 불가리아
      • Burgas, 불가리아, 8000
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      • Plovdiv, 불가리아, 4004
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      • Sofia, 불가리아, 1330
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      • Varna, 불가리아, 9000
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  • 브라질
      • Barretos, 브라질, 14784-400
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      • Florianópolis, 브라질, 88034-000
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      • Fortaleza, 브라질, 60810-180
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      • Londrina, 브라질, 86015-520
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      • Porto Alegre, 브라질, 90020-090
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      • São Paulo, 브라질, 01317-000
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      • São Paulo, 브라질, 04014-002
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  • 스페인
      • Córdoba, 스페인, 14004
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      • Madrid, 스페인, 28034
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      • Madrid, 스페인, 28041
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      • Madrid, 스페인, 28040
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      • Madrid, 스페인, 28033
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      • Terrassa(Barcelona), 스페인, 08221
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      • Vigo, 스페인, 36312
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  • 오스트리아
      • Graz, 오스트리아, 8036
        • Research Site
      • Innsbruck, 오스트리아, 6020
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      • Linz, 오스트리아, 4020
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      • Vienna, 오스트리아, 1090
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  • 이탈리아
      • Brescia, 이탈리아, 25123
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      • Lecce, 이탈리아, 73100
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      • Lecco, 이탈리아, 23900
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      • Milan, 이탈리아, 20141
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      • Milan, 이탈리아, 20132
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      • Mirano, 이탈리아, 30035
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      • Naples, 이탈리아, 80131
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      • Roma, 이탈리아, 00168
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      • Torino, 이탈리아, 10126
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      • Torino, 이탈리아, 10128
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  • 일본
      • Fukuoka, 일본, 811-1395
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      • Kashiwa-shi, 일본, 277-8567
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      • Kobe, 일본, 650-0047
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      • Kurume-shi, 일본, 830-0011
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      • Kyoto, 일본, 606-8507
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      • Kōtoku, 일본, 135-8550
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      • Minatoku, 일본, 105-8471
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      • Nagoya, 일본, 464-8681
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      • Niigata, 일본, 951-8520
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      • Okayama, 일본, 700-8558
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      • Sapporo, 일본, 003-0804
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      • Sendai, 일본, 980-8574
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      • Shinjuku-ku, 일본, 160-8582
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      • Sunto-gun, 일본, 411-8777
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      • Toyoake-shi, 일본, 470-1192
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  • 중국
      • Beijing, 중국, CN-100730
        • Research Site
      • Beijing, 중국, 100026
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      • Bengbu, 중국, 233004
        • Research Site
      • Changchun, 중국, 130021
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      • Changsha, 중국, 410008
        • Research Site
      • Changsha, 중국, 430033
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      • Chengdu, 중국, 610041
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      • Chongqing, 중국, 400030
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      • Dalian, 중국, 116001
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      • Guangzhou, 중국, 510080
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      • Guangzhou, 중국, 510060
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      • Hangzhou, 중국, 310022
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      • Hangzhou, 중국, 310009
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      • Harbin, 중국, 150081
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      • Hefei, 중국, 230031
        • Research Site
      • Jinhua, 중국, 321099
        • Research Site
      • Kunming, 중국, 650118
        • Research Site
      • Lanzhou, 중국, 730030
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      • Luzhou, 중국, 646099
        • Research Site
      • Nanchong, 중국, 637000
        • Research Site
      • Nanjing, 중국, 2100008
        • Research Site
      • Nanning, 중국, 530021
        • Research Site
      • Nantong, 중국, 226361
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      • Shanghai, 중국, 200011
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      • Shanghai, 중국, 200032
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      • Wuhan, 중국, 430030
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      • Wuhan, 중국, 430060
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      • Xi'an, 중국, 710061
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      • Zhengzhou, 중국, 450008
        • Research Site
      • Zhengzhou, 중국, 450002
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      • Zhuhai, 중국, 519099
        • Research Site
  • 캐나다
    • Alberta
      • Calgary, Alberta, 캐나다, T2N 5G2
        • Research Site
    • Ontario
      • Barrie, Ontario, 캐나다, L4M 6M2
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      • Greater Sudbury, Ontario, 캐나다, P3E 5J1
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      • Toronto, Ontario, 캐나다, M5G 2M9
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    • Quebec
      • Montreal, Quebec, 캐나다, H4A 3J1
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      • Montreal, Quebec, 캐나다, H3T 1E2
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      • Montreal, Quebec, 캐나다, H2X 3E4
        • Research Site
      • Québec, Quebec, 캐나다, G1J 1Z4
        • Research Site
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  • 터키 (Türkiye)
      • Adana, 터키 (Türkiye), 1260
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      • Ankara, 터키 (Türkiye), 06230
        • Research Site
      • Ankara, 터키 (Türkiye), 06490
        • Research Site
      • Istanbul, 터키 (Türkiye), 34093
        • Research Site
      • Istanbul, 터키 (Türkiye), 34384
        • Research Site
      • Izmir, 터키 (Türkiye), 35100
        • Research Site
  • 페루
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      • La Libertad, 페루, 13013
        • Research Site
      • Lima, 페루, LIMA 34
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      • Lima, 페루, LIMA 41
        • Research Site
      • Lima, 페루, LIMA 31
        • Research Site
      • Lima, 페루, Lima 32
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      • San Isidro, 페루, 27
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  • 폴란드
      • Gdynia, 폴란드, 81-519
        • Research Site
      • Lodz, 폴란드, 93-513
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      • Szczecin, 폴란드, 70-111
        • Research Site
      • Warsaw, 폴란드, 02-781
        • Research Site
      • Warsaw, 폴란드, 04-141
        • Research Site
  • 프랑스
      • Besançon, 프랑스, 25000
        • Research Site
      • Bordeaux, 프랑스, 33076
        • Research Site
      • Limoges, 프랑스, 87042
        • Research Site
      • Lyon, 프랑스, 69373
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      • Marseille, 프랑스, 13273
        • Research Site
      • Nantes, 프랑스, 44202
        • Research Site
      • Paris, 프랑스, 75012
        • Research Site
      • Paris, 프랑스, 75015
        • Research Site
      • Paris, 프랑스, 75674
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      • Saint-Herblain, 프랑스, 44805
        • Research Site
      • Vandœuvre-lès-Nancy, 프랑스, 54519
        • Research Site
  • 핀란드
      • Kuopio, 핀란드, 70210
        • Research Site
      • Oulu, 핀란드, 90029
        • Research Site
      • Turku, 핀란드, 20521
        • Research Site
  • 헝가리
      • Budapest, 헝가리, 1122
        • Research Site
      • Budapest, 헝가리, 1062
        • Research Site
      • Debrecen, 헝가리, 4032
        • Research Site
      • Győr, 헝가리, 9024
        • Research Site
      • Kaposvár, 헝가리, 7400
        • Research Site
      • Szeged, 헝가리, 6725
        • Research Site
      • Zalaegerszeg, 헝가리, 8900
        • Research Site

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 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

설명

주요 포함 기준:

새로 진단되고, 조직학적으로 확인된, 진행성(단계 III-IV) 높은 등급의 심각한, 높은 등급의 자궁내막양, 투명 세포 난소암 또는 암육종, 원발성 복막암 및/또는 나팔관암을 포함하는 높은 등급의 상피성 난소암을 가진 여성 환자

  • 환자는 18세 이상이어야 합니다. 일본에 등록된 고령 환자
  • 모든 환자는 세포감소 수술 대상자여야 합니다. 사전 1차 수술 또는 간격 축소 수술과 함께 화학요법을 받을 계획
  • 종양 조직에서 BRCA1/2 돌연변이의 존재 또는 부재의 증거
  • 중앙 집중식 tBRCA 검사를 위한 종양 샘플 의무 제공
  • ECOG 수행 상태 0-1
  • 환자는 장기 및 골수 기능이 보존되어 있어야 합니다.
  • 가임 여성의 폐경 후 또는 비가임 상태의 증거: 음성 소변 또는 혈청 임신 검사

주요 제외 기준:

비상피성 난소암, 경계성 종양, 저등급 상피성 종양 또는 점액성 조직학

  • 난소암에 대한 선행 전신 항암 요법
  • 유해하거나 유해한 것으로 의심되는 BRCA 돌연변이의 존재 또는 부재를 판단할 수 없음
  • PARP 억제제 또는 면역 매개 요법으로 사전 치료
  • 계획된 복강 내 세포 독성 화학 요법
  • 활동성 또는 이전에 기록된 자가면역 또는 염증성 장애
  • 심각하고 통제되지 않는 병발성 질병으로 인해 의학적 위험이 낮은 것으로 간주되는 환자
  • 임상적으로 중요한 심혈관 질환
  • 뇌 전이가 알려진 환자

  • 다음을 제외한 다른 원발성 악성 종양의 병력:

    • 치료 목적으로 치료되고 연구 치료의 첫 번째 투여 전 5년 이상 알려진 활성 질환이 없고 재발에 대한 잠재적 위험이 낮은 악성 종양(초기 유방암에 대해 이전에 보조 화학 요법을 받은 환자는 완료한 경우 적격일 수 있음) 등록 전 ≥3년, 환자가 재발성 또는 전이성 질환이 없음)
    • 질병의 증거 없이 적절하게 치료된 비흑색종 피부암 또는 악성 흑자
    • 질병의 증거 없이 적절하게 치료된 상피내 암종
    • 자궁내막암 FIGO IA기, 1등급 또는 2등급
  • 이전 암 요법으로 인한 지속적인 독성 CTCAE 등급 >2
  • olaparib, durvalumab 또는 이들 제품의 부형제 및 조합/비교 제제에 알려진 과민증이 있는 환자
  • 모유 수유 여성

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: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 팔 1
베바시주맙 및 더발루맙 위약(식염수 IV 주입)과 병용한 백금 기반 화학요법 이후 베바시주맙, 더발루맙 위약(식염수 IV 주입) 및 올라파립 위약(정제) 유지 관리.
의약품: 베바시주맙
정맥 주입에 의한 베바시주맙. tBRCAm 코호트에서 베바시주맙은 현지 관행에 따라 선택 사항입니다.
의약품: 위약 올라파립
올라파립과 일치하는 위약 정제
의약품: Durvalumab 위약
정맥 주입을 위한 일치하는 위약
의약품: 카보플라틴+파클리탁셀
치료 표준 화학 요법
실험적: 팔 2
베바시주맙 및 더발루맙과 병용한 백금 기반 화학요법 이후 베바시주맙, 더발루맙 및 올라파립 위약 유지.
의약품: 베바시주맙
정맥 주입에 의한 베바시주맙. tBRCAm 코호트에서 베바시주맙은 현지 관행에 따라 선택 사항입니다.
의약품: 위약 올라파립
올라파립과 일치하는 위약 정제
의약품: 카보플라틴+파클리탁셀
치료 표준 화학 요법
의약품: 더발루맙
정맥 주입에 의한 Durvalumab
실험적: 팔 3
베바시주맙 및 더발루맙과 병용한 백금 기반 화학요법 이후 베바시주맙, 더발루맙 및 올라파립 유지.
의약품: 올라파립
올라파립 정제
의약품: 베바시주맙
정맥 주입에 의한 베바시주맙. tBRCAm 코호트에서 베바시주맙은 현지 관행에 따라 선택 사항입니다.
의약품: 카보플라틴+파클리탁셀
치료 표준 화학 요법
의약품: 더발루맙
정맥 주입에 의한 Durvalumab
실험적: tBRCAm 코호트
베바시주맙 및 더발루맙과 병용한 백금 기반 화학요법 이후 베바시주맙, 더발루맙 및 올라파립 유지. Bevacizumab은 현지 관행에 따라 선택 사항입니다.
의약품: 올라파립
올라파립 정제
의약품: 베바시주맙
정맥 주입에 의한 베바시주맙. tBRCAm 코호트에서 베바시주맙은 현지 관행에 따라 선택 사항입니다.
의약품: 카보플라틴+파클리탁셀
치료 표준 화학 요법
의약품: 더발루맙
정맥 주입에 의한 Durvalumab

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Progression-free Survival (PFS) by Investigator Assessment Using Modified RECIST 1.1 - Full Analysis Set
기간: At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Assessed until primary analysis - (05DEC2022 for Global cohort, 17MAR2025 for China cohort) - upto 46 months

To determine the efficacy of durvalumab in combination with platinum based chemotherapy and bevacizumab and continued as maintenance in combination with bevacizumab and olaparib versus SoC platinum based chemotherapy in combination with bevacizumab by assessment of PFS (using investigator assessment according to Response Evaluation Criteria in Solid Tumours version 1.1 [RECIST 1.1]) in the first line treatment of patients with newly diagnosed advanced ovarian cancer.

Per MTP, the comparison of SoC+D+O v SoC in the Non-tbRCAm patients is a primary endpoint. SoC+D v SoC is reported separately as a secondary endpoint. Results for tBRCAm SoC+D+O are not presented as this was prespecified to be assessed only in the Non-tBRCAm patients.
At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Assessed until primary analysis - (05DEC2022 for Global cohort, 17MAR2025 for China cohort) - upto 46 months
Progression-free Survival (PFS) by Investigator Assessment Using Modified RECIST 1.1 - (Full Analysis Set, HRD Positive)
기간: At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Assessed until DCO1 - (05DEC2022 for Global cohort, 17MAR2025 for China cohort) - upto 46 months

To determine the efficacy of durvalumab and olaparib assessed by PFS in the first line treatment of patients with newly diagnosed advanced ovarian cancer.

Per MTP, the comparison of SoC+D+O v SoC in the Non-tBRCAm HRD positve population is a primary endpoint. SoC+D v SoC is reported separately as a secondary endpoint. Results for tBRCAm SoC+D+O are not presented as as this was prespecified to be assessed only in the Non-tBRCAm patients.
At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Assessed until DCO1 - (05DEC2022 for Global cohort, 17MAR2025 for China cohort) - upto 46 months

2차 결과 측정

결과 측정
측정값 설명
기간
Progression-free Survival (PFS) by Investigator Assessment Using Modified RECIST 1.1 - Full Analysis Set
기간: At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. For global cohort, assessed until DCO2 (18SEP2023) - up to 55 months. For China cohort assessed until DCO1 (17MAR2025) - 46 months.

To determine the efficacy of durvalumab assessed by PFS in the first line treatment of patients with newly diagnosed advanced ovarian cancer.

Per MTP, the comparison of SoC+D v SoC is a secondary endpoint. SoC+D+O v SoC is reported separately as a primary endpoint. Results for tBRCAm SoC+D+O are not presented as this was prespecified to be assessed only in the Non-tBRCAm patients.
At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. For global cohort, assessed until DCO2 (18SEP2023) - up to 55 months. For China cohort assessed until DCO1 (17MAR2025) - 46 months.
Overall Survival - Full Analysis Set
기간: Survival assessed every 12 weeks after RECIST 1.1 defined progression. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - up to 46 months.

To determine the efficacy of durvalumab and olaparib assessed by OS in the first line treatment patients with newly diagnosed advanced ovarian cancer.

Overall survival (OS) is defined as the time from randomisation/allocation to death due to any cause regardless of whether the patient withdraws from randomised therapy or receives another anti-cancer therapy.

Results for tBRCAm SoC+D+O are not presented as this was prespecified to be assessed only in the Non-tBRCAm patients.
Survival assessed every 12 weeks after RECIST 1.1 defined progression. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - up to 46 months.
Overall Survival - (Full Analysis Set, HRD-positive)
기간: Survival assessed every 12 weeks after RECIST 1.1 defined progression. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - up to 46 months.

To determine the efficacy of durvalumab and olaparib assessed by OS in the first line treatment patients with newly diagnosed advanced ovarian cancer.

Overall survival (OS) is defined as the time from randomisation/allocation to death due to any cause regardless of whether the patient withdraws from randomised therapy or receives another anti-cancer therapy.

Results for tBRCAm SoC+D+O are not presented as this was prespecified to be assessed only in the Non-tBRCAm patients.
Survival assessed every 12 weeks after RECIST 1.1 defined progression. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - up to 46 months.
Time to Second Progression or Death Based on Local Standard Clinical Practice (PFS2) - Full Analysis Set
기간: Assessed every 12 weeks after RECIST 1.1 defined progression. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - 46 months.

To assess the efficacy of durvalumab and olaparib in terms of PFS2 in the first line treatment of patients with newly diagnosed advanced ovarian cancer.

Time to second progression or death (PFS2) is defined as the time from the date of randomisation/allocation to the earliest of the progression event subsequent to first subsequent therapy or death.

Results for tBRCAm SoC+D+O are not presented as this was prespecified to be assessed only in the Non-tBRCAm patients.
Assessed every 12 weeks after RECIST 1.1 defined progression. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - 46 months.
Time to Second Progression or Death Based on Local Standard Clinical Practice (PFS2) - (Full Analysis Set, HRD-positive)
기간: Assessed every 12 weeks after RECIST 1.1 defined progression. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - 46 months.

To assess the efficacy of durvalumab and olaparib in terms of PFS2 in the first line treatment of patients with newly diagnosed advanced ovarian cancer.

Time to second progression or death (PFS2) is defined as the time from the date of randomisation/allocation to the earliest of the progression event subsequent to first subsequent therapy or death.

Results for tBRCAm SoC+D+O are not presented as this was prespecified to be assessed only in the Non-tBRCAm patients.
Assessed every 12 weeks after RECIST 1.1 defined progression. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - 46 months.
Objective Response Rate Based on Investigator Assessment (Full Analysis Set)
기간: At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Up to 55 months for global non-tBRCAm (DCO2 18SEP2023). Up to 46 for Global tBRCAm (DCO1 05DEC2022) and China (DCO1 17MAR2025)

To assess the efficacy of durvalumab and olaparib in terms of ORR (Complete Response + Partial Response) by investigator assessment by modified RECIST 1.1:

  1. in all patients with evaluable disease at baseline
  2. prior to surgery in those patients planned to have IDS with evaluable disease at baseline.

Objective response rate (ORR) is defined similarly for the non-tBRCAm and tBRCAm cohorts as the number (percentage) of patients with at least one investigator-assessed visit response of CR or PR and will be based on a subset of all randomised/allocated patients who have evaluable disease at baseline per the site investigator.
At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Up to 55 months for global non-tBRCAm (DCO2 18SEP2023). Up to 46 for Global tBRCAm (DCO1 05DEC2022) and China (DCO1 17MAR2025)
Objective Response Rate Based on Investigator Assessment (Full Analysis Set, HRD-positive)
기간: At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Up to 55 months for global non-tBRCAm (DCO2 18SEP2023). Up to 46 for China (DCO1 17MAR2025)

To assess the efficacy of durvalumab and olaparib in terms of ORR (Complete Response + Partial Response) by investigator assessment by modified RECIST 1.1

  1. in all patients with evaluable disease at baseline
  2. prior to surgery in those patients planned to have IDS with evaluable disease at baseline.

Objective response rate (ORR) is defined similarly for the non-tBRCAm and tBRCAm cohorts as the number (percentage) of patients with at least one investigator-assessed visit response of CR or PR and will be based on a subset of all randomised/allocated patients who have evaluable disease at baseline per the site investigator.

This was prespecified to be assessed only in the non-tBRCAm cohort.
At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Up to 55 months for global non-tBRCAm (DCO2 18SEP2023). Up to 46 for China (DCO1 17MAR2025)
Duration of Objective Response Based on Investigator Assessments (Full Analysis Set)
기간: At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Up to 55 months for global non-tBRCAm (DCO2 18SEP2023). Up to 46 for Global tBRCAm (DCO1 05DEC2022)

To assess the efficacy of durvalumab and olaparib in terms of duration of response (DoR) in the first line treatment of patients with newly diagnosed advanced ovarian cancer.

Duration of response (DoR) is defined similarly for the non-tBRCAm and tBRCAm cohorts using the corresponding FAS among patients with a response (CR or PR), as the time from the date of first documented response (i.e., the first time at which the visit response is PR or CR) according to modified RECIST v1.1 as assessed by the investigator until date of documented progression or death in the absence of disease progression.

This was prespecified to be assessed only in the Global patients.
At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Up to 55 months for global non-tBRCAm (DCO2 18SEP2023). Up to 46 for Global tBRCAm (DCO1 05DEC2022)
Duration of Objective Response Based on Investigator Assessments (Full Analysis Set, HRD-positive)
기간: At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Up to 55 months for global non-tBRCAm (DCO2 18SEP2023).

To assess the efficacy of durvalumab and olaparib in terms of duration of response (DoR) in the first line treatment of patients with newly diagnosed advanced ovarian cancer.

Duration of response (DoR) is defined similarly for the non-tBRCAm and tBRCAm cohorts using the corresponding FAS among patients with a response (CR or PR), as the time from the date of first documented response (i.e., the first time at which the visit response is PR or CR) according to modified RECIST v1.1 as assessed by the investigator until date of documented progression or death in the absence of disease progression.

This was prespecified to be assessed only in Global Non-tBRCAm patients.
At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Up to 55 months for global non-tBRCAm (DCO2 18SEP2023).
Time to First Subsequent Therapy (TFST) - Full Analysis Set
기간: Assessed every 12 weeks following treatment discontinuation. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - up to 46 months.

To assess the efficacy of durvalumab and olaparib in terms of TFST in the first line treatment of patients with newly diagnosed advanced ovarian cancer.

Time to start of first subsequent therapy or death (TFST) is defined as the time from randomisation/allocation to the earlier of first subsequent therapy start date following study treatment discontinuation, or death.

This was prespecified to be assessed only in Non-tBRCAm patients.
Assessed every 12 weeks following treatment discontinuation. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - up to 46 months.
Time to First Subsequent Therapy (TFST) - (Full Analysis Set, HRD-positive)
기간: Assessed every 12 weeks following treatment discontinuation. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - up to 46 months.

To assess the efficacy of durvalumab and olaparib in terms of TFST in the first line treatment of patients with newly diagnosed advanced ovarian cancer.

Time to start of first subsequent therapy or death (TFST) is defined as the time from randomisation/allocation to the earlier of first subsequent therapy start date following study treatment discontinuation, or death.

This was prespecified to be assessed only in Non-tBRCAm patients.
Assessed every 12 weeks following treatment discontinuation. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - up to 46 months.
Time to Second Subsequent Therapy (TSST) - Full Analysis Set
기간: Assessed every 12 weeks following treatment discontinuation. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - up to 46 months.

To assess the efficacy of durvalumab and olaparib in terms of TSST in the first line treatment of patients with newly diagnosed advanced ovarian cancer.

Time to second subsequent therapy or death (TSST) is defined as the time from randomisation/allocation to the earlier of the second subsequent anti-cancer therapy start date following study treatment discontinuation, or death.

This was prespecified to be assessed only in Non-tBRCAm patients.
Assessed every 12 weeks following treatment discontinuation. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - up to 46 months.
Time to Second Subsequent Therapy (TSST) - (Full Analysis Set, HRD-positive)
기간: Assessed every 12 weeks following treatment discontinuation. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - up to 46 months.

To assess the efficacy of durvalumab and olaparib in terms of TSST in the first line treatment of patients with newly diagnosed advanced ovarian cancer.

Time to second subsequent therapy or death (TSST) is defined as the time from randomisation to the earlier of the second subsequent anti-cancer therapy start date following study treatment discontinuation, or death.

This was prespecified to be assessed only in Non-tBRCAm patients.
Assessed every 12 weeks following treatment discontinuation. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - up to 46 months.
Time to Treatment Discontinuation (TDT) - Full Analysis Set
기간: Assessed through study completion, up to 73 months for global non-tBRCAm (DCO3 17MAR2025) and up to 46 months for and China (DCO1 17MAR2025)

To assess the efficacy of durvalumab and olaparib in terms of TDT in the first line treatment of patients with newly diagnosed advanced ovarian cancer.

Time to permanent study treatment discontinuation or death (TDT) is defined as the time from randomisation/allocation to the earlier of the date of permanent study treatment discontinuation or death.

This was prespecified to be assessed only in Non-tBRCAm patients.
Assessed through study completion, up to 73 months for global non-tBRCAm (DCO3 17MAR2025) and up to 46 months for and China (DCO1 17MAR2025)
Time to Treatment Discontinuation (TDT) - (Full Analysis Set, HRD-positive)
기간: Assessed through study completion, up to 73 months for global non-tBRCAm (DCO3 17MAR2025) and up to 46 months for and China (DCO1 17MAR2025)

To assess the efficacy of durvalumab and olaparib in terms of TDT in the first line treatment of patients with newly diagnosed advanced ovarian cancer.

Time to permanent study treatment discontinuation or death (TDT) is defined as the time from randomisation/allocation to the earlier of the date of permanent study treatment discontinuation or death.

This was prespecified to be assessed only in Non-tBRCAm patients.
Assessed through study completion, up to 73 months for global non-tBRCAm (DCO3 17MAR2025) and up to 46 months for and China (DCO1 17MAR2025)
Change From Baseline in Physical Function Score of the EORTC-QLQ-C30 and EORTC-QLQ-OV28 Questionnaires - Full Analysis Set
기간: Assessed at week 96.

To determine the effects on HRQoL, global health status and ovarian cancer symptoms of the combination of durvalumab and olaparib in the first line treatment of non-tBRCAm patients with newly diagnosed advanced ovarian cancer. The physical functioning score is a score from 0 to 100. Higher scores on the physical functioning score indicate better health status/function.

This was prespecified to be assessed only in Global Non-tBRCAm patients.
Assessed at week 96.
Change From Baseline in Physical Function Score of the EORTC-QLQ-C30 and EORTC-QLQ-OV28 Questionnaires - (Full Analysis Set, HRD Positive)
기간: Assessed at week 96.

To determine the effects on HRQoL, global health status and ovarian cancer symptoms of the combination of durvalumab and olaparib in the first line treatment of non-tBRCAm patients with newly diagnosed advanced ovarian cancer. The physical functioning score is a score from 0 to 100. Higher scores on the physical functioning score indicate better health status/function.

This was prespecified to be assessed only in Global Non-tBRCAm patients.
Assessed at week 96.
Change From Baseline in Global Health Status/QoL Score of the EORTC-QLQ-C30 and EORTC-QLQ-OV28 Questionnaires - Full Analysis Set
기간: Assessed at week 96.

To determine the effects on HRQoL, global health status and ovarian cancer symptoms of the combination of durvalumab and olaparib in the first line treatment of non-tBRCAm patients with newly diagnosed advanced ovarian cancer. The global health status/quality of life (QoL) is a score from 0 to 100. Higher scores on the global health status/QoL indicate better health status/function.

This was prespecified to be assessed only in Global Non-tBRCAm patients.
Assessed at week 96.
Change From Baseline in Global Health Status/QoL Score of the EORTC-QLQ-C30 and EORTC-QLQ-OV28 Questionnaires - (Full Analysis Set, HRD Positive)
기간: Assessed at week 96

To determine the effects on HRQoL, global health status and ovarian cancer symptoms of the combination of durvalumab and olaparib in the first line treatment of non-tBRCAm patients with newly diagnosed advanced ovarian cancer. The global health status/quality of life (QoL) is a score from 0 to 100. Higher scores on the global health status/QoL indicate better health status/function.

This was prespecified to be assessed only in Global Non-tBRCAm patients.
Assessed at week 96
Summary of Serum Concentrations (μg/mL) of Durvalumab for Each Treatment - Non-tBRCAm Cohort With Primary Cytoreductive Surgery (Pharmacokinetic Analysis Set)
기간: Assessed at Day 85 pre-dose, Day 183 pre-dose and 3 months after last dose of durvalumab.

To characterize the PK of durvalumab in combination with bevacizumab and olaparib.

This was prespecified to be assessed only in Global Non-tBRCAm patients.
Assessed at Day 85 pre-dose, Day 183 pre-dose and 3 months after last dose of durvalumab.
Summary of Plasma Concentrations (μg/mL) of Olaparib - Non-tBRCAm Cohort With Primary Cytoreductive Surgery (Pharmacokinetic Analysis Set)
기간: Assessed on Day 148 post-dose (1-3 hours, 3-6 hours and 6-12 hours)

To determine olaparib plasma concentrations via sparse sampling for population PK analyses.

This was prespecified to be assessed only in Global Non-tBRCAm patients.
Assessed on Day 148 post-dose (1-3 hours, 3-6 hours and 6-12 hours)
Summary of ADA Responses During the Study for Durvalumab - Non-tBRCAm Cohort With Primary Cytoreductive Surgery (ADA Analysis Set)
기간: Assessed pre-infusion at Cycle 2, Cycle 4, Cycle 6 and the third cycle of the maintenance phase as well as 3 months after last dose of durvalumab

To characterize the immunogenicity of durvalumab in combination with bevacizumab and olaparib.

This was prespecified to be assessed only in Global Non-tBRCAm patients.
Assessed pre-infusion at Cycle 2, Cycle 4, Cycle 6 and the third cycle of the maintenance phase as well as 3 months after last dose of durvalumab

기타 결과 측정

결과 측정
측정값 설명
기간
AE/SAE 평가를 통한 약물의 안전성 및 내약성
기간: 약 4년
국립 암 연구소(NCI CTCAE)에 따라 등급이 매겨짐
약 4년

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

AstraZeneca

협력자

GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Myriad Genetic Laboratories, Inc.

수사관

  • 수석 연구원: Philipp Harter, European Network of Gynaecological Oncological Trial Groups (ENGOT)
  • 수석 연구원: Carol Aghajanian, GOG

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

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)

2019년 1월 4일

기본 완료 (실제)

2025년 3월 17일

연구 완료 (추정된)

2026년 12월 23일

연구 등록 날짜

최초 제출

2018년 10월 15일

QC 기준을 충족하는 최초 제출

2018년 11월 8일

처음 게시됨 (실제)

2018년 11월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 8일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • D081RC00001
  • 2017-004632-11 (EudraCT 번호)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

자격을 갖춘 연구원은 요청 포털을 통해 임상 시험을 후원하는 AstraZeneca 그룹의 익명화된 개별 환자 수준 데이터에 대한 액세스를 요청할 수 있습니다. 모든 요청은 AZ 공개 약속(https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure)에 따라 평가됩니다.

IPD 공유 기간

AstraZeneca는 EFPIA 제약 데이터 공유 원칙에 대한 약속에 따라 데이터 가용성을 충족하거나 초과할 것입니다. 타임라인에 대한 자세한 내용은 https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure에서 공개 약속을 참조하십시오.

IPD 공유 액세스 기준

요청이 승인되면 AstraZeneca는 승인된 후원 도구에서 비식별화된 개별 환자 수준 데이터에 대한 액세스를 제공합니다. 요청된 정보에 액세스하기 전에 서명된 데이터 공유 계약(데이터 접근자를 위한 협상 불가능한 계약)이 있어야 합니다. 또한 모든 사용자가 액세스 권한을 얻으려면 SAS MSE의 약관에 동의해야 합니다. 자세한 내용은 https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure에서 공개 성명서를 검토하십시오.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

예

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. .

진행성 난소암에 대한 임상 시험

올라파립에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Kosovo

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다