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Durvalumab 联合化疗和贝伐单抗治疗，随后在晚期卵巢癌患者中维持 Durvalumab、Bevacizumab 和 Olaparib 治疗 (DUO-O)

2026年7月3日 更新者：AstraZeneca

在新诊断的晚期卵巢癌患者 (DUO-O) 中进行 Durvalumab 联合化疗和贝伐单抗，随后维持 Durvalumab、贝伐单抗和 Olaparib 的 III 期随机、双盲、安慰剂对照、多中心研究。

这是一项 III 期随机、双盲、多中心研究，旨在评估 durvalumab 联合标准护理铂类化疗和贝伐珠单抗，然后维持 durvalumab 和贝伐珠单抗或 durvalumab、贝伐珠单抗和奥拉帕尼在新发患者中的疗效和安全性诊断为晚期卵巢癌。

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

符合条件的患者将是那些新诊断的、经组织学证实的晚期（国际妇产科联合会 [FIGO] III-IV 期）卵巢癌、原发性腹膜癌和/或输卵管癌的患者。 所有患者都应该是细胞减灭术的候选者，该手术可以在诊断后立即作为前期主要手术进行，也可以在以铂类为基础的新辅助化疗开始后进行。 所有患者都应该有资格开始一线铂类化疗联合贝伐珠单抗。

该研究旨在评估标准护理 (SoC) 铂类化疗和贝伐珠单抗继以维持贝伐珠单抗作为单一疗法，或与 durvalumab 联合使用，或与 durvalumab 和 olaparib 联合使用的疗效和安全性。 因此，这项研究旨在了解哪种组合可以让患者在癌症不会复发或恶化的情况下活得更久。 该研究还希望了解哪种组合可以延长患者的寿命，以及治疗和癌症如何影响他们的生活质量。

研究类型

介入性

注册 (实际的)

1407

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
      • Beijing、中国、CN-100730
        • Research Site
      • Beijing、中国、100026
        • Research Site
      • Bengbu、中国、233004
        • Research Site
      • Changchun、中国、130021
        • Research Site
      • Changsha、中国、410008
        • Research Site
      • Changsha、中国、430033
        • Research Site
      • Chengdu、中国、610041
        • Research Site
      • Chongqing、中国、400030
        • Research Site
      • Dalian、中国、116001
        • Research Site
      • Guangzhou、中国、510080
        • Research Site
      • Guangzhou、中国、510060
        • Research Site
      • Hangzhou、中国、310022
        • Research Site
      • Hangzhou、中国、310009
        • Research Site
      • Harbin、中国、150081
        • Research Site
      • Hefei、中国、230031
        • Research Site
      • Jinhua、中国、321099
        • Research Site
      • Kunming、中国、650118
        • Research Site
      • Lanzhou、中国、730030
        • Research Site
      • Luzhou、中国、646099
        • Research Site
      • Nanchong、中国、637000
        • Research Site
      • Nanjing、中国、2100008
        • Research Site
      • Nanning、中国、530021
        • Research Site
      • Nantong、中国、226361
        • Research Site
      • Shanghai、中国、200011
        • Research Site
      • Shanghai、中国、200032
        • Research Site
      • Wuhan、中国、430030
        • Research Site
      • Wuhan、中国、430060
        • Research Site
      • Xi'an、中国、710061
        • Research Site
      • Zhengzhou、中国、450008
        • Research Site
      • Zhengzhou、中国、450002
        • Research Site
      • Zhuhai、中国、519099
        • Research Site
  • 丹麦
      • Aalborg、丹麦、9000
        • Research Site
      • Aarhus N、丹麦、8200
        • Research Site
      • Odense、丹麦、5000
        • Research Site
      • Roskilde、丹麦、4000
        • Research Site
      • Vejle、丹麦、7100
        • Research Site
  • 保加利亚
      • Burgas、保加利亚、8000
        • Research Site
      • Plovdiv、保加利亚、4004
        • Research Site
      • Sofia、保加利亚、1330
        • Research Site
      • Varna、保加利亚、9000
        • Research Site
  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大、T2N 5G2
        • Research Site
    • Ontario
      • Barrie、Ontario、加拿大、L4M 6M2
        • Research Site
      • Greater Sudbury、Ontario、加拿大、P3E 5J1
        • Research Site
      • Toronto、Ontario、加拿大、M5G 2M9
        • Research Site
    • Quebec
      • Montreal、Quebec、加拿大、H4A 3J1
        • Research Site
      • Montreal、Quebec、加拿大、H3T 1E2
        • Research Site
      • Montreal、Quebec、加拿大、H2X 3E4
        • Research Site
      • Québec、Quebec、加拿大、G1J 1Z4
        • Research Site
      • Rimouski、Quebec、加拿大、G5L 5T1
        • Research Site
  • 匈牙利
      • Budapest、匈牙利、1122
        • Research Site
      • Budapest、匈牙利、1062
        • Research Site
      • Debrecen、匈牙利、4032
        • Research Site
      • Győr、匈牙利、9024
        • Research Site
      • Kaposvár、匈牙利、7400
        • Research Site
      • Szeged、匈牙利、6725
        • Research Site
      • Zalaegerszeg、匈牙利、8900
        • Research Site
  • 土耳其（türkiye）
      • Adana、土耳其（türkiye）、1260
        • Research Site
      • Ankara、土耳其（türkiye）、06230
        • Research Site
      • Ankara、土耳其（türkiye）、06490
        • Research Site
      • Istanbul、土耳其（türkiye）、34093
        • Research Site
      • Istanbul、土耳其（türkiye）、34384
        • Research Site
      • Izmir、土耳其（türkiye）、35100
        • Research Site
  • 奥地利
      • Graz、奥地利、8036
        • Research Site
      • Innsbruck、奥地利、6020
        • Research Site
      • Linz、奥地利、4020
        • Research Site
      • Vienna、奥地利、1090
        • Research Site
  • 巴西
      • Barretos、巴西、14784-400
        • Research Site
      • Florianópolis、巴西、88034-000
        • Research Site
      • Fortaleza、巴西、60810-180
        • Research Site
      • Londrina、巴西、86015-520
        • Research Site
      • Porto Alegre、巴西、90020-090
        • Research Site
      • Porto Alegre、巴西、90110-270
        • Research Site
      • Rio de Janeiro、巴西、20220-410
        • Research Site
      • São Paulo、巴西、01317-000
        • Research Site
      • São Paulo、巴西、04014-002
        • Research Site
  • 德国
      • Bad Homburg、德国、61352
        • Research Site
      • Berlin、德国、10117
        • Research Site
      • Bielefeld、德国、33604
        • Research Site
      • Bonn、德国、53105
        • Research Site
      • Brandenburg、德国、14770
        • Research Site
      • Cologne、德国、50935
        • Research Site
      • Dresden、德国、1307
        • Research Site
      • Düsseldorf、德国、40489
        • Research Site
      • Essen、德国、45136
        • Research Site
      • Essen、德国、45147
        • Research Site
      • Esslingen am Neckar、德国、73730
        • Research Site
      • Frankfurt、德国、60590
        • Research Site
      • Freiburg im Breisgau、德国、79106
        • Research Site
      • Fürth、德国、90766
        • Research Site
      • Greifswald、德国、17475
        • Research Site
      • Gütersloh、德国、33332
        • Research Site
      • Hamburg、德国、20246
        • Research Site
      • Hamburg、德国、20357
        • Research Site
      • Hamburg、德国、22457
        • Research Site
      • Hanover、德国、30625
        • Research Site
      • Hanover、德国、30177
        • Research Site
      • Jena、德国、07747
        • Research Site
      • Karlsruhe、德国、76135
        • Research Site
      • Karlsruhe、德国、76133
        • Research Site
      • Kassel、德国、34125
        • Research Site
      • Kiel、德国、24105
        • Research Site
      • Leipzig、德国、04103
        • Research Site
      • Ludwigsburg、德国、71640
        • Research Site
      • Lübeck、德国、23538
        • Research Site
      • Mainz、德国、55131
        • Research Site
      • Mannheim、德国、68167
        • Research Site
      • München、德国、81377
        • Research Site
      • Offenbach、德国、63069
        • Research Site
      • Oldenburg、德国、26133
        • Research Site
      • Rosenheim、德国、83022
        • Research Site
      • Rostock、德国、18057
        • Research Site
      • Saalfeld、德国、07318
        • Research Site
      • Schweinfurt、德国、97422
        • Research Site
      • Tübingen、德国、72016
        • Research Site
      • Ulm、德国、89075
        • Research Site
      • Worms、德国、67550
        • Research Site
  • 意大利
      • Brescia、意大利、25123
        • Research Site
      • Lecce、意大利、73100
        • Research Site
      • Lecco、意大利、23900
        • Research Site
      • Milan、意大利、20141
        • Research Site
      • Milan、意大利、20132
        • Research Site
      • Mirano、意大利、30035
        • Research Site
      • Naples、意大利、80131
        • Research Site
      • Reggio Calabria、意大利、89100
        • Research Site
      • Reggio Emilia、意大利、42100
        • Research Site
      • Roma、意大利、00168
        • Research Site
      • Torino、意大利、10126
        • Research Site
      • Torino、意大利、10128
        • Research Site
  • 日本
      • Fukuoka、日本、811-1395
        • Research Site
      • Kashiwa-shi、日本、277-8567
        • Research Site
      • Kobe、日本、650-0047
        • Research Site
      • Kurume-shi、日本、830-0011
        • Research Site
      • Kyoto、日本、606-8507
        • Research Site
      • Kōtoku、日本、135-8550
        • Research Site
      • Minatoku、日本、105-8471
        • Research Site
      • Nagoya、日本、464-8681
        • Research Site
      • Niigata、日本、951-8520
        • Research Site
      • Okayama、日本、700-8558
        • Research Site
      • Sapporo、日本、003-0804
        • Research Site
      • Sendai、日本、980-8574
        • Research Site
      • Shinjuku-ku、日本、160-8582
        • Research Site
      • Sunto-gun、日本、411-8777
        • Research Site
      • Toyoake-shi、日本、470-1192
        • Research Site
  • 比利时
      • Aalst、比利时、9300
        • Research Site
      • Leuven、比利时、3000
        • Research Site
      • Namur、比利时、5000
        • Research Site
      • Ostend、比利时、8400
        • Research Site
      • Sint-Niklaas、比利时、9100
        • Research Site
  • 法国
      • Besançon、法国、25000
        • Research Site
      • Bordeaux、法国、33076
        • Research Site
      • Limoges、法国、87042
        • Research Site
      • Lyon、法国、69373
        • Research Site
      • Marseille、法国、13273
        • Research Site
      • Nantes、法国、44202
        • Research Site
      • Paris、法国、75012
        • Research Site
      • Paris、法国、75015
        • Research Site
      • Paris、法国、75674
        • Research Site
      • Saint-Herblain、法国、44805
        • Research Site
      • Vandœuvre-lès-Nancy、法国、54519
        • Research Site
  • 波兰
      • Gdynia、波兰、81-519
        • Research Site
      • Lodz、波兰、93-513
        • Research Site
      • Szczecin、波兰、70-111
        • Research Site
      • Warsaw、波兰、02-781
        • Research Site
      • Warsaw、波兰、04-141
        • Research Site
  • 秘鲁
      • Bellavista、秘鲁、CALLAO 2
        • Research Site
      • La Libertad、秘鲁、13013
        • Research Site
      • Lima、秘鲁、LIMA 34
        • Research Site
      • Lima、秘鲁、LIMA 41
        • Research Site
      • Lima、秘鲁、LIMA 31
        • Research Site
      • Lima、秘鲁、Lima 32
        • Research Site
      • San Isidro、秘鲁、27
        • Research Site
  • 罗马尼亚
      • Floreşti、罗马尼亚、407280
        • Research Site
  • 美国
    • California
      • Foothill Ranch、California、美国、92610
        • Research Site
      • Los Angeles、California、美国、90095
        • Research Site
      • Orange、California、美国、92868-3298
        • Research Site
      • San Francisco、California、美国、94158
        • Research Site
    • Florida
      • Tampa、Florida、美国、33612
        • Research Site
    • Georgia
      • Augusta、Georgia、美国、30912
        • Research Site
    • Illinois
      • Hinsdale、Illinois、美国、60521
        • Research Site
    • Indiana
      • Indianapolis、Indiana、美国、46202
        • Research Site
    • Maryland
      • Towson、Maryland、美国、21204
        • Research Site
    • Michigan
      • Detroit、Michigan、美国、48202
        • Research Site
    • Missouri
      • Springfield、Missouri、美国、65807
        • Research Site
    • New Jersey
      • Middletown、New Jersey、美国、07748
        • Research Site
      • Montvale、New Jersey、美国、07645
        • Research Site
    • New York
      • Albany、New York、美国、12208
        • Research Site
      • New York、New York、美国、10065
        • Research Site
      • Uniondale、New York、美国、11553
        • Research Site
    • North Carolina
      • Durham、North Carolina、美国、27710
        • Research Site
    • Ohio
      • Cleveland、Ohio、美国、44195
        • Research Site
      • Dayton、Ohio、美国、45429
        • Research Site
      • Hilliard、Ohio、美国、43026
        • Research Site
    • Oklahoma
      • Tulsa、Oklahoma、美国、74134
        • Research Site
    • Pennsylvania
      • Lancaster、Pennsylvania、美国、17601
        • Research Site
      • Philadelphia、Pennsylvania、美国、19104
        • Research Site
      • Philadelphia、Pennsylvania、美国、19107-5097
        • Research Site
      • Pittsburgh、Pennsylvania、美国、15224
        • Research Site
    • Utah
      • Salt Lake City、Utah、美国、84112
        • Research Site
  • 芬兰
      • Kuopio、芬兰、70210
        • Research Site
      • Oulu、芬兰、90029
        • Research Site
      • Turku、芬兰、20521
        • Research Site
  • 西班牙
      • Córdoba、西班牙、14004
        • Research Site
      • Madrid、西班牙、28034
        • Research Site
      • Madrid、西班牙、28041
        • Research Site
      • Madrid、西班牙、28040
        • Research Site
      • Madrid、西班牙、28033
        • Research Site
      • Terrassa(Barcelona)、西班牙、08221
        • Research Site
      • Vigo、西班牙、36312
        • Research Site
  • 韩国
      • Goyang-si、韩国、10408
        • Research Site
      • Seongnam-si、韩国、13620
        • Research Site
      • Seoul、韩国、03080
        • Research Site
      • Seoul、韩国、03722
        • Research Site
      • Seoul、韩国、06351
        • Research Site
      • Suwon、韩国、16499
        • Research Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 130年 (成人、年长者)

接受健康志愿者

不

描述

关键纳入标准：

新诊断、经组织学证实的晚期（III-IV 期）高级别上皮性卵巢癌包括高级别严重、高级别子宫内膜癌、透明细胞卵巢癌或癌肉瘤、原发性腹膜癌和/或输卵管癌的女性患者

  • 患者必须年满 18 岁。 对于在日本登记的老年患者
  • 所有患者都应该是细胞减灭术的候选者：前期初次手术或计划接受间歇性减瘤手术的化疗
  • 肿瘤组织中存在或不存在 BRCA1/2 突变的证据
  • 强制提供肿瘤样本以进行集中式 tBRCA 检测
  • ECOG 体能状态 0-1
  • 患者必须保留器官和骨髓功能
  • 有生育能力的女性绝经后或非生育状态的证据：尿液或血清妊娠试验阴性

关键排除标准：

非上皮性卵巢癌、交界性肿瘤、低级别上皮性肿瘤或粘液性组织学

  • 先前对卵巢癌进行全身抗癌治疗
  • 无法确定是否存在有害或疑似有害 BRCA 突变
  • 先前使用 PARP 抑制剂或免疫介导疗法治疗
  • 计划性腹腔内细胞毒性化疗
  • 活动性或先前记录的自身免疫性或炎症性疾病
  • 由于严重的、不受控制的并发疾病，患者被认为有较差的医疗风险
  • 有临床意义的心血管疾病
  • 已知有脑转移的患者

  • 另一种原发性恶性肿瘤的病史，除了：

    • 以治愈为目的治疗的恶性肿瘤，在第一次研究治疗前 ≥ 5 年没有已知的活动性疾病，并且复发的潜在风险较低（先前接受过早期乳腺癌辅助化疗的患者可能符合条件，前提是完成注册前 ≥ 3 年，并且患者没有复发或转移性疾病）
    • 没有疾病证据的非黑色素瘤皮肤癌或恶性雀斑得到充分治疗
    • 没有疾病证据的原位癌得到充分治疗
    • 子宫内膜癌 FIGO IA 期，1 级或 2 级
  • 先前癌症治疗引起的 CTCAE >2 级持续毒性
  • 已知对奥拉帕尼、度伐鲁单抗或这些产品的任何赋形剂以及联合/比较剂过敏的患者
  • 母乳喂养的妇女

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
有源比较器：手臂 1
铂类化疗联合贝伐珠单抗和 durvalumab 安慰剂（盐水静脉输注），然后维持贝伐珠单抗、durvalumab 安慰剂（盐水静脉输注）和奥拉帕尼安慰剂（片剂）。
药品：贝伐单抗
贝伐珠单抗静脉滴注。 在 tBRCAm 队列中，根据当地实践，贝伐珠单抗是可选的。
药品：安慰剂奥拉帕尼
与奥拉帕尼匹配的安慰剂药片
药品：Durvalumab 安慰剂
静脉输注匹配安慰剂
药品：卡铂+紫杉醇
护理化疗标准
实验性的：手臂 2
铂类化疗联合贝伐单抗和度伐单抗，然后维持贝伐单抗、度伐单抗和奥拉帕尼安慰剂。
药品：贝伐单抗
贝伐珠单抗静脉滴注。 在 tBRCAm 队列中，根据当地实践，贝伐珠单抗是可选的。
药品：安慰剂奥拉帕尼
与奥拉帕尼匹配的安慰剂药片
药品：卡铂+紫杉醇
护理化疗标准
药品：度伐单抗
Durvalumab 静脉输注
实验性的：手臂 3
铂类化疗联合贝伐单抗和度伐单抗，然后维持贝伐单抗、度伐单抗和奥拉帕尼。
药品：奥拉帕尼
奥拉帕尼片
药品：贝伐单抗
贝伐珠单抗静脉滴注。 在 tBRCAm 队列中，根据当地实践，贝伐珠单抗是可选的。
药品：卡铂+紫杉醇
护理化疗标准
药品：度伐单抗
Durvalumab 静脉输注
实验性的：tBRCAm 队列
铂类化疗联合贝伐单抗和度伐单抗，然后维持贝伐单抗、度伐单抗和奥拉帕尼。 根据当地实践，贝伐珠单抗是可选的。
药品：奥拉帕尼
奥拉帕尼片
药品：贝伐单抗
贝伐珠单抗静脉滴注。 在 tBRCAm 队列中，根据当地实践，贝伐珠单抗是可选的。
药品：卡铂+紫杉醇
护理化疗标准
药品：度伐单抗
Durvalumab 静脉输注

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Progression-free Survival (PFS) by Investigator Assessment Using Modified RECIST 1.1 - Full Analysis Set
大体时间：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)
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Progression-free Survival (PFS) by Investigator Assessment Using Modified RECIST 1.1 - Full Analysis Set
大体时间：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
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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

其他结果措施

结果测量
措施说明
大体时间
通过 AE/SAE 评估药物的安全性和耐受性
大体时间：约4年
根据美国国家癌症研究所 (NCI CTCAE) 分级
约4年

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

AstraZeneca

合作者

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

调查人员

  • 首席研究员：Philipp Harter、European Network of Gynaecological Oncological Trial Groups (ENGOT)
  • 首席研究员：Carol Aghajanian、GOG

出版物和有用的链接

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一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年1月4日

初级完成 (实际的)

2025年3月17日

研究完成 (估计的)

2026年12月23日

研究注册日期

首次提交

2018年10月15日

首先提交符合 QC 标准的

2018年11月8日

首次发布 (实际的)

2018年11月9日

研究记录更新

最后更新发布 (实际的)

2026年7月7日

上次提交的符合 QC 标准的更新

2026年7月3日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

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

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

合格的研究人员可以通过请求门户请求访问阿斯利康集团公司赞助的临床试验的匿名个人患者数据。 所有请求都将根据 AZ 披露承诺进行评估：https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure。

IPD 共享时间框架

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IPD 共享访问标准

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IPD 共享支持信息类型

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  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

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