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Tratamento com Durvalumabe em Combinação com Quimioterapia e Bevacizumabe, Seguido de Tratamento de Manutenção com Durvalumabe, Bevacizumabe e Olaparibe em Pacientes com Câncer de Ovário Avançado (DUO-O)

8 de junho de 2026 atualizado por: AstraZeneca

Um estudo multicêntrico, randomizado, duplo-cego, controlado por placebo de Fase III de Durvalumabe em combinação com quimioterapia e Bevacizumabe, seguido por manutenção de Durvalumabe, Bevacizumabe e Olaparibe em pacientes recém-diagnosticadas com câncer de ovário avançado (DUO-O).

Este é um estudo randomizado, duplo-cego e multicêntrico de Fase III para avaliar a eficácia e a segurança de durvalumabe em combinação com quimioterapia padrão baseada em platina e bevacizumabe seguido de durvalumabe e bevacizumabe de manutenção ou durvalumabe, bevacizumabe e olaparibe em pacientes com diagnosticado câncer de ovário avançado.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

Os pacientes elegíveis serão aqueles com câncer de ovário, peritoneal primário e/ou câncer de trompas de falópio avançado, recém-diagnosticado e confirmado histologicamente (Fédération Internationale de Gynécologie et d'Obstétrique [FIGO] Estágio III-IV). Todos os pacientes devem ser candidatos à cirurgia citorredutora, que pode ser realizada como cirurgia primária inicial imediata após o diagnóstico ou pode ser realizada após o início da quimioterapia neoadjuvante à base de platina. Todos os pacientes devem ser elegíveis para iniciar quimioterapia de primeira linha à base de platina em combinação com bevacizumabe.

O estudo tem como objetivo avaliar a eficácia e a segurança da quimioterapia à base de platina padrão de tratamento (SoC) e bevacizumabe seguido de bevacizumabe de manutenção como monoterapia, ou em combinação com durvalumabe, ou em combinação com durvalumabe e olaparibe. Portanto, este estudo visa ver qual combinação permite que os pacientes vivam mais tempo sem que o câncer volte ou piore. O estudo também procura ver qual combinação faz os pacientes viverem mais e como o tratamento e o câncer afetam sua qualidade de vida.

Tipo de estudo

Intervencional

Inscrição (Real)

1407

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 130 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Descrição

Principais Critérios de Inclusão:

Pacientes do sexo feminino com câncer de ovário epitelial de alto grau recém-diagnosticado, confirmado histologicamente, avançado (estágio III-IV), incluindo câncer de ovário de células claras ou carcinossarcoma grave de alto grau, endométrio de alto grau, câncer de ovário de células claras ou carcinossarcoma, câncer peritoneal primário e/ou câncer de trompa de Falópio

  • Os pacientes devem ter ≥18 anos de idade. Para pacientes matriculados no Japão com idade
  • Todos os pacientes devem ser candidatos à cirurgia citorredutora: cirurgia primária inicial OU planejar a quimioterapia com cirurgia de citorredução de intervalo
  • Evidência de presença ou ausência de mutação BRCA1/2 no tecido tumoral
  • Fornecimento obrigatório de amostra de tumor para teste tBRCA centralizado
  • Status de desempenho ECOG 0-1
  • Os pacientes devem ter órgão preservado e função da medula óssea
  • Pós-menopausa ou evidência de estado não fértil para mulheres com potencial para engravidar: urina negativa ou teste de gravidez sérico

Principais Critérios de Exclusão:

Câncer de ovário não epitelial, tumores borderline, tumores epiteliais de baixo grau ou histologia mucinosa

  • Terapia anticancerígena sistêmica prévia para câncer de ovário
  • Incapacidade de determinar a presença ou ausência de uma mutação BRCA deletéria ou suspeita deletéria
  • Tratamento prévio com inibidor de PARP ou terapia imunomediada
  • Quimioterapia citotóxica intraperitoneal planejada
  • Distúrbios autoimunes ou inflamatórios ativos ou previamente documentados
  • Pacientes considerados de baixo risco médico devido a uma doença intercorrente grave e descontrolada
  • Doença cardiovascular clinicamente significativa
  • Pacientes com metástases cerebrais conhecidas

  • História de outra malignidade primária, exceto por:

    • Malignidade tratada com intenção curativa e sem doença ativa conhecida ≥5 anos antes da primeira dose do tratamento do estudo e de baixo risco potencial de recorrência (pacientes que receberam quimioterapia adjuvante anterior para câncer de mama em estágio inicial podem ser elegíveis, desde que tenha sido concluída ≥3 anos antes do registro e que o paciente permaneça livre de doença recorrente ou metastática)
    • Câncer de pele não melanoma adequadamente tratado ou lentigo maligno sem evidência de doença
    • Carcinoma in situ adequadamente tratado sem evidência de doença
    • Câncer de endométrio FIGO Estágio IA, Grau 1 ou Grau 2
  • Toxicidades persistentes Grau CTCAE > 2 causadas por terapia anterior contra o câncer
  • Pacientes com hipersensibilidade conhecida a olaparibe, durvalumabe ou qualquer um dos excipientes desses produtos e aos agentes combinados/comparadores
  • Mulheres que amamentam

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Braço 1
Quimioterapia à base de platina em combinação com bevacizumabe e durvalumabe placebo (infusão salina IV) seguido de manutenção com bevacizumabe, durvalumabe placebo (infusão salina IV) e olaparibe placebo (comprimidos).
Medicamento: Bevacizumabe
Bevacizumabe por infusão intravenosa. Na coorte tBRCAm, o bevacizumabe é opcional de acordo com a prática local.
Medicamento: Placebo olaparibe
Comprimidos placebo para combinar com olaparibe
Medicamento: Durvalumabe placebo
Placebo correspondente para infusão intravenosa
Medicamento: Carboplatina + Paclitaxel
Padrão de tratamento quimioterápico
Experimental: Braço 2
Quimioterapia à base de platina em combinação com bevacizumabe e durvalumabe seguido por bevacizumabe de manutenção, durvalumabe e olaparibe placebo.
Medicamento: Bevacizumabe
Bevacizumabe por infusão intravenosa. Na coorte tBRCAm, o bevacizumabe é opcional de acordo com a prática local.
Medicamento: Placebo olaparibe
Comprimidos placebo para combinar com olaparibe
Medicamento: Carboplatina + Paclitaxel
Padrão de tratamento quimioterápico
Medicamento: Durvalumabe
Durvalumabe por infusão intravenosa
Experimental: Braço 3
Quimioterapia baseada em platina em combinação com bevacizumabe e durvalumabe, seguida de manutenção com bevacizumabe, durvalumabe e olaparibe.
Medicamento: Olaparibe
Comprimidos de olaparibe
Medicamento: Bevacizumabe
Bevacizumabe por infusão intravenosa. Na coorte tBRCAm, o bevacizumabe é opcional de acordo com a prática local.
Medicamento: Carboplatina + Paclitaxel
Padrão de tratamento quimioterápico
Medicamento: Durvalumabe
Durvalumabe por infusão intravenosa
Experimental: coorte tBRCAm
Quimioterapia baseada em platina em combinação com bevacizumabe e durvalumabe, seguida de manutenção com bevacizumabe, durvalumabe e olaparibe. Bevacizumab é opcional de acordo com a prática local.
Medicamento: Olaparibe
Comprimidos de olaparibe
Medicamento: Bevacizumabe
Bevacizumabe por infusão intravenosa. Na coorte tBRCAm, o bevacizumabe é opcional de acordo com a prática local.
Medicamento: Carboplatina + Paclitaxel
Padrão de tratamento quimioterápico
Medicamento: Durvalumabe
Durvalumabe por infusão intravenosa

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Progression-free Survival (PFS) by Investigator Assessment Using Modified RECIST 1.1 - Full Analysis Set
Prazo: 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)
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Progression-free Survival (PFS) by Investigator Assessment Using Modified RECIST 1.1 - Full Analysis Set
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Segurança e tolerabilidade de medicamentos por avaliação de AEs/SAEs
Prazo: Aproximadamente 4 anos
Classificado de acordo com o National Cancer Institute (NCI CTCAE)
Aproximadamente 4 anos

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

AstraZeneca

Colaboradores

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

Investigadores

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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

4 de janeiro de 2019

Conclusão Primária (Real)

17 de março de 2025

Conclusão do estudo (Estimado)

23 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

15 de outubro de 2018

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de novembro de 2018

Primeira postagem (Real)

9 de novembro de 2018

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de junho de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Pesquisadores qualificados podem solicitar acesso a dados anônimos de pacientes individuais do grupo AstraZeneca de ensaios clínicos patrocinados por empresas por meio do portal de solicitação. Todas as solicitações serão avaliadas de acordo com o compromisso de divulgação da AZ: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Prazo de Compartilhamento de IPD

A AstraZeneca atenderá ou excederá a disponibilidade de dados de acordo com os compromissos assumidos com os Princípios de Compartilhamento de Dados Farmacêuticos da EFPIA. Para obter detalhes sobre nossos cronogramas, consulte novamente nosso compromisso de divulgação em https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Critérios de acesso de compartilhamento IPD

Quando uma solicitação for aprovada, a AstraZeneca fornecerá acesso aos dados individuais não identificados no nível do paciente em uma ferramenta patrocinada aprovada. O Contrato de Compartilhamento de Dados assinado (contrato não negociável para acessadores de dados) deve estar em vigor antes de acessar as informações solicitadas. Além disso, todos os usuários precisarão aceitar os termos e condições do SAS MSE para obter acesso. Para obter detalhes adicionais, consulte as declarações de divulgação em https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Sim

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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Condições

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