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Tratamiento con durvalumab en combinación con quimioterapia y bevacizumab, seguido de tratamiento de mantenimiento con durvalumab, bevacizumab y olaparib en pacientes con cáncer de ovario avanzado (DUO-O)

8 de junio de 2026 actualizado por: AstraZeneca

Estudio de fase III multicéntrico, aleatorizado, doble ciego, controlado con placebo de durvalumab en combinación con quimioterapia y bevacizumab, seguido de mantenimiento con durvalumab, bevacizumab y olaparib en pacientes con cáncer de ovario avanzado recién diagnosticado (DUO-O).

Este es un estudio multicéntrico, doble ciego, aleatorizado de fase III para evaluar la eficacia y la seguridad de durvalumab en combinación con quimioterapia estándar basada en platino y bevacizumab seguido de mantenimiento con durvalumab y bevacizumab o durvalumab, bevacizumab y olaparib en pacientes con diagnosticado de cáncer de ovario avanzado.

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

Los pacientes elegibles serán aquellos pacientes con cáncer de ovario, peritoneal primario y/o cáncer de las trompas de Falopio avanzado (Fédération Internationale de Gynécologie et d'Obstétrique [FIGO] Etapa III-IV) recientemente diagnosticado e histológicamente confirmado. Todos los pacientes deben ser candidatos para la cirugía citorreductora, que podría realizarse como cirugía primaria inmediata después del diagnóstico o después del inicio de la quimioterapia neoadyuvante basada en platino. Todos los pacientes deben ser elegibles para comenzar la quimioterapia de primera línea basada en platino en combinación con bevacizumab.

El estudio tiene como objetivo evaluar la eficacia y la seguridad de la quimioterapia basada en platino estándar de atención (SoC) y bevacizumab seguido de bevacizumab de mantenimiento, ya sea como monoterapia, en combinación con durvalumab, o en combinación con durvalumab y olaparib. Por lo tanto, este estudio tiene como objetivo ver qué combinación permite que los pacientes vivan más tiempo sin que el cáncer regrese o empeore. El estudio también busca ver qué combinación hace que los pacientes vivan más tiempo y cómo el tratamiento y el cáncer afectan su calidad de vida.

Tipo de estudio

Intervencionista

Inscripción (Actual)

1407

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Bad Homburg, Alemania, 61352
        • Research Site
      • Berlin, Alemania, 10117
        • Research Site
      • Bielefeld, Alemania, 33604
        • Research Site
      • Bonn, Alemania, 53105
        • Research Site
      • Brandenburg, Alemania, 14770
        • Research Site
      • Cologne, Alemania, 50935
        • Research Site
      • Dresden, Alemania, 1307
        • Research Site
      • Düsseldorf, Alemania, 40489
        • Research Site
      • Essen, Alemania, 45136
        • Research Site
      • Essen, Alemania, 45147
        • Research Site
      • Esslingen am Neckar, Alemania, 73730
        • Research Site
      • Frankfurt, Alemania, 60590
        • Research Site
      • Freiburg im Breisgau, Alemania, 79106
        • Research Site
      • Fürth, Alemania, 90766
        • Research Site
      • Greifswald, Alemania, 17475
        • Research Site
      • Gütersloh, Alemania, 33332
        • Research Site
      • Hamburg, Alemania, 20246
        • Research Site
      • Hamburg, Alemania, 20357
        • Research Site
      • Hamburg, Alemania, 22457
        • Research Site
      • Hanover, Alemania, 30625
        • Research Site
      • Hanover, Alemania, 30177
        • Research Site
      • Jena, Alemania, 07747
        • Research Site
      • Karlsruhe, Alemania, 76135
        • Research Site
      • Karlsruhe, Alemania, 76133
        • Research Site
      • Kassel, Alemania, 34125
        • Research Site
      • Kiel, Alemania, 24105
        • Research Site
      • Leipzig, Alemania, 04103
        • Research Site
      • Ludwigsburg, Alemania, 71640
        • Research Site
      • Lübeck, Alemania, 23538
        • Research Site
      • Mainz, Alemania, 55131
        • Research Site
      • Mannheim, Alemania, 68167
        • Research Site
      • München, Alemania, 81377
        • Research Site
      • Offenbach, Alemania, 63069
        • Research Site
      • Oldenburg, Alemania, 26133
        • Research Site
      • Rosenheim, Alemania, 83022
        • Research Site
      • Rostock, Alemania, 18057
        • Research Site
      • Saalfeld, Alemania, 07318
        • Research Site
      • Schweinfurt, Alemania, 97422
        • Research Site
      • Tübingen, Alemania, 72016
        • Research Site
      • Ulm, Alemania, 89075
        • Research Site
      • Worms, Alemania, 67550
        • Research Site
  • Austria
      • Graz, Austria, 8036
        • Research Site
      • Innsbruck, Austria, 6020
        • Research Site
      • Linz, Austria, 4020
        • Research Site
      • Vienna, Austria, 1090
        • 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
  • Bulgaria
      • Burgas, Bulgaria, 8000
        • Research Site
      • Plovdiv, Bulgaria, 4004
        • Research Site
      • Sofia, Bulgaria, 1330
        • Research Site
      • Varna, Bulgaria, 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
  • Corea del Sur
      • Goyang-si, Corea del Sur, 10408
        • Research Site
      • Seongnam-si, Corea del Sur, 13620
        • Research Site
      • Seoul, Corea del Sur, 03080
        • Research Site
      • Seoul, Corea del Sur, 03722
        • Research Site
      • Seoul, Corea del Sur, 06351
        • Research Site
      • Suwon, Corea del Sur, 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
  • España
      • Córdoba, España, 14004
        • Research Site
      • Madrid, España, 28034
        • Research Site
      • Madrid, España, 28041
        • Research Site
      • Madrid, España, 28040
        • Research Site
      • Madrid, España, 28033
        • Research Site
      • Terrassa(Barcelona), España, 08221
        • Research Site
      • Vigo, España, 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
  • Finlandia
      • Kuopio, Finlandia, 70210
        • Research Site
      • Oulu, Finlandia, 90029
        • Research Site
      • Turku, Finlandia, 20521
        • Research Site
  • Francia
      • Besançon, Francia, 25000
        • Research Site
      • Bordeaux, Francia, 33076
        • Research Site
      • Limoges, Francia, 87042
        • Research Site
      • Lyon, Francia, 69373
        • Research Site
      • Marseille, Francia, 13273
        • Research Site
      • Nantes, Francia, 44202
        • Research Site
      • Paris, Francia, 75012
        • Research Site
      • Paris, Francia, 75015
        • Research Site
      • Paris, Francia, 75674
        • Research Site
      • Saint-Herblain, Francia, 44805
        • Research Site
      • Vandœuvre-lès-Nancy, Francia, 54519
        • Research Site
  • Hungría
      • Budapest, Hungría, 1122
        • Research Site
      • Budapest, Hungría, 1062
        • Research Site
      • Debrecen, Hungría, 4032
        • Research Site
      • Győr, Hungría, 9024
        • Research Site
      • Kaposvár, Hungría, 7400
        • Research Site
      • Szeged, Hungría, 6725
        • Research Site
      • Zalaegerszeg, Hungría, 8900
        • Research Site
  • Italia
      • Brescia, Italia, 25123
        • Research Site
      • Lecce, Italia, 73100
        • Research Site
      • Lecco, Italia, 23900
        • Research Site
      • Milan, Italia, 20141
        • Research Site
      • Milan, Italia, 20132
        • Research Site
      • Mirano, Italia, 30035
        • Research Site
      • Naples, Italia, 80131
        • Research Site
      • Reggio Calabria, Italia, 89100
        • Research Site
      • Reggio Emilia, Italia, 42100
        • Research Site
      • Roma, Italia, 00168
        • Research Site
      • Torino, Italia, 10126
        • Research Site
      • Torino, Italia, 10128
        • Research Site
  • Japón
      • Fukuoka, Japón, 811-1395
        • Research Site
      • Kashiwa-shi, Japón, 277-8567
        • Research Site
      • Kobe, Japón, 650-0047
        • Research Site
      • Kurume-shi, Japón, 830-0011
        • Research Site
      • Kyoto, Japón, 606-8507
        • Research Site
      • Kōtoku, Japón, 135-8550
        • Research Site
      • Minatoku, Japón, 105-8471
        • Research Site
      • Nagoya, Japón, 464-8681
        • Research Site
      • Niigata, Japón, 951-8520
        • Research Site
      • Okayama, Japón, 700-8558
        • Research Site
      • Sapporo, Japón, 003-0804
        • Research Site
      • Sendai, Japón, 980-8574
        • Research Site
      • Shinjuku-ku, Japón, 160-8582
        • Research Site
      • Sunto-gun, Japón, 411-8777
        • Research Site
      • Toyoake-shi, Japón, 470-1192
        • Research Site
  • Perú
      • Bellavista, Perú, CALLAO 2
        • Research Site
      • La Libertad, Perú, 13013
        • Research Site
      • Lima, Perú, Lima 34
        • Research Site
      • Lima, Perú, LIMA 41
        • Research Site
      • Lima, Perú, LIMA 31
        • Research Site
      • Lima, Perú, Lima 32
        • Research Site
      • San Isidro, Perú, 27
        • Research Site
  • Polonia
      • Gdynia, Polonia, 81-519
        • Research Site
      • Lodz, Polonia, 93-513
        • Research Site
      • Szczecin, Polonia, 70-111
        • Research Site
      • Warsaw, Polonia, 02-781
        • Research Site
      • Warsaw, Polonia, 04-141
        • Research Site
  • Porcelana
      • Beijing, Porcelana, CN-100730
        • Research Site
      • Beijing, Porcelana, 100026
        • Research Site
      • Bengbu, Porcelana, 233004
        • Research Site
      • Changchun, Porcelana, 130021
        • Research Site
      • Changsha, Porcelana, 410008
        • Research Site
      • Changsha, Porcelana, 430033
        • Research Site
      • Chengdu, Porcelana, 610041
        • Research Site
      • Chongqing, Porcelana, 400030
        • Research Site
      • Dalian, Porcelana, 116001
        • Research Site
      • Guangzhou, Porcelana, 510080
        • Research Site
      • Guangzhou, Porcelana, 510060
        • Research Site
      • Hangzhou, Porcelana, 310022
        • Research Site
      • Hangzhou, Porcelana, 310009
        • Research Site
      • Harbin, Porcelana, 150081
        • Research Site
      • Hefei, Porcelana, 230031
        • Research Site
      • Jinhua, Porcelana, 321099
        • Research Site
      • Kunming, Porcelana, 650118
        • Research Site
      • Lanzhou, Porcelana, 730030
        • Research Site
      • Luzhou, Porcelana, 646099
        • Research Site
      • Nanchong, Porcelana, 637000
        • Research Site
      • Nanjing, Porcelana, 2100008
        • Research Site
      • Nanning, Porcelana, 530021
        • Research Site
      • Nantong, Porcelana, 226361
        • Research Site
      • Shanghai, Porcelana, 200011
        • Research Site
      • Shanghai, Porcelana, 200032
        • Research Site
      • Wuhan, Porcelana, 430030
        • Research Site
      • Wuhan, Porcelana, 430060
        • Research Site
      • Xi'an, Porcelana, 710061
        • Research Site
      • Zhengzhou, Porcelana, 450008
        • Research Site
      • Zhengzhou, Porcelana, 450002
        • Research Site
      • Zhuhai, Porcelana, 519099
        • Research Site
  • Rumania
      • Floreşti, Rumania, 407280
        • Research Site
  • Turquía (Türkiye)
      • Adana, Turquía (Türkiye), 1260
        • Research Site
      • Ankara, Turquía (Türkiye), 06230
        • Research Site
      • Ankara, Turquía (Türkiye), 06490
        • Research Site
      • Istanbul, Turquía (Türkiye), 34093
        • Research Site
      • Istanbul, Turquía (Türkiye), 34384
        • Research Site
      • Izmir, Turquía (Türkiye), 35100
        • Research Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 130 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Descripción

Criterios clave de inclusión:

Pacientes de sexo femenino con cáncer de ovario epitelial de alto grado avanzado (etapa III-IV) recién diagnosticado, histológicamente confirmado, incluido cáncer de ovario de células claras o carcinosarcoma de alto grado grave, endometriod de alto grado, cáncer peritoneal primario y/o cáncer de las trompas de Falopio

  • Los pacientes deben tener ≥18 años de edad. Para pacientes inscritos en Japón que tienen una edad
  • Todos los pacientes deben ser candidatos para la cirugía citorreductora ya sea: cirugía primaria inicial O planear someterse a quimioterapia con cirugía de reducción de volumen a intervalos
  • Evidencia de presencia o ausencia de mutación BRCA1/2 en tejido tumoral
  • Provisión obligatoria de muestra de tumor para pruebas centralizadas de tBRCA
  • Estado funcional ECOG 0-1
  • Los pacientes deben tener función preservada del órgano y de la médula ósea.
  • Posmenopáusicas o evidencia de estado no fértil para mujeres en edad fértil: prueba de embarazo negativa en orina o suero

Criterios clave de exclusión:

Cáncer de ovario no epitelial, tumores borderline, tumores epiteliales de bajo grado o histología mucinosa

  • Terapia anticancerígena sistémica previa para el cáncer de ovario
  • Incapacidad para determinar la presencia o ausencia de una mutación BRCA perjudicial o presuntamente perjudicial
  • Tratamiento previo con inhibidor de PARP o terapia inmunomediada
  • Quimioterapia citotóxica intraperitoneal planificada
  • Trastornos autoinmunes o inflamatorios activos o previamente documentados
  • Pacientes considerados de bajo riesgo médico debido a una enfermedad intercurrente grave no controlada
  • Enfermedad cardiovascular clínicamente significativa
  • Pacientes con metástasis cerebrales conocidas

  • Antecedentes de otra neoplasia maligna primaria excepto por:

    • Neoplasia maligna tratada con intención curativa y sin enfermedad activa conocida ≥ 5 años antes de la primera dosis del tratamiento del estudio y de bajo riesgo potencial de recurrencia (los pacientes que hayan recibido quimioterapia adyuvante previa para el cáncer de mama en estadio temprano pueden ser elegibles, siempre que se haya completado ≥3 años antes del registro, y que el paciente permanece libre de enfermedad recurrente o metastásica)
    • Cáncer de piel no melanoma o lentigo maligno tratado adecuadamente sin evidencia de enfermedad
    • Carcinoma in situ adecuadamente tratado sin evidencia de enfermedad
    • Cáncer de endometrio Estadio FIGO IA, Grado 1 o Grado 2
  • Toxicidades persistentes CTCAE Grado >2 causadas por terapia previa contra el cáncer
  • Pacientes con hipersensibilidad conocida a olaparib, durvalumab o cualquiera de los excipientes de estos productos y a los agentes combinados/comparadores
  • mujeres lactantes

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Brazo 1
Quimioterapia basada en platino en combinación con bevacizumab y durvalumab placebo (infusión de solución salina IV) seguida de bevacizumab de mantenimiento, durvalumab placebo (infusión de solución salina IV) y olaparib placebo (tabletas).
Droga: Bevacizumab
Bevacizumab por infusión intravenosa. En la cohorte tBRCAm, bevacizumab es opcional según la práctica local.
Droga: Placebo olaparib
Tabletas de placebo para combinar con olaparib
Droga: Durvalumab placebo
Placebo de combinación para infusión intravenosa
Droga: Carboplatino + Paclitaxel
Quimioterapia estándar de atención
Experimental: Brazo 2
Quimioterapia basada en platino en combinación con bevacizumab y durvalumab seguida de bevacizumab de mantenimiento, durvalumab y olaparib placebo.
Droga: Bevacizumab
Bevacizumab por infusión intravenosa. En la cohorte tBRCAm, bevacizumab es opcional según la práctica local.
Droga: Placebo olaparib
Tabletas de placebo para combinar con olaparib
Droga: Carboplatino + Paclitaxel
Quimioterapia estándar de atención
Droga: Durvalumab
Durvalumab por infusión intravenosa
Experimental: Brazo 3
Quimioterapia basada en platino en combinación con bevacizumab y durvalumab seguida de bevacizumab, durvalumab y olaparib de mantenimiento.
Droga: Olaparib
Tabletas de olaparib
Droga: Bevacizumab
Bevacizumab por infusión intravenosa. En la cohorte tBRCAm, bevacizumab es opcional según la práctica local.
Droga: Carboplatino + Paclitaxel
Quimioterapia estándar de atención
Droga: Durvalumab
Durvalumab por infusión intravenosa
Experimental: cohorte tBRCAm
Quimioterapia basada en platino en combinación con bevacizumab y durvalumab seguida de bevacizumab, durvalumab y olaparib de mantenimiento. Bevacizumab es opcional según la práctica local.
Droga: Olaparib
Tabletas de olaparib
Droga: Bevacizumab
Bevacizumab por infusión intravenosa. En la cohorte tBRCAm, bevacizumab es opcional según la práctica local.
Droga: Carboplatino + Paclitaxel
Quimioterapia estándar de atención
Droga: Durvalumab
Durvalumab por infusión intravenosa

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression-free Survival (PFS) by Investigator Assessment Using Modified RECIST 1.1 - Full Analysis Set
Periodo de tiempo: 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)
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression-free Survival (PFS) by Investigator Assessment Using Modified RECIST 1.1 - Full Analysis Set
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Seguridad y tolerabilidad de los medicamentos mediante la evaluación de AA/SAE
Periodo de tiempo: Aproximadamente 4 años
Clasificado según el Instituto Nacional del Cáncer (NCI CTCAE)
Aproximadamente 4 años

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

4 de enero de 2019

Finalización primaria (Actual)

17 de marzo de 2025

Finalización del estudio (Estimado)

23 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

15 de octubre de 2018

Primero enviado que cumplió con los criterios de control de calidad

8 de noviembre de 2018

Publicado por primera vez (Actual)

9 de noviembre de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

8 de junio de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Los investigadores calificados pueden solicitar acceso a datos anónimos a nivel de pacientes individuales de los ensayos clínicos patrocinados por el grupo de empresas AstraZeneca a través del portal de solicitudes. Todas las solicitudes se evaluarán según el compromiso de divulgación de AZ: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Marco de tiempo para compartir IPD

AstraZeneca cumplirá o superará la disponibilidad de datos según los compromisos adquiridos con los Principios de intercambio de datos farmacéuticos de EFPIA. Para obtener detalles sobre nuestros plazos, consulte nuestro compromiso de divulgación en https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Criterios de acceso compartido de IPD

Cuando se haya aprobado una solicitud, AstraZeneca proporcionará acceso a los datos de nivel de paciente individual no identificado en una herramienta patrocinada aprobada. El Acuerdo de intercambio de datos firmado (contrato no negociable para quienes acceden a los datos) debe estar vigente antes de acceder a la información solicitada. Además, todos los usuarios deberán aceptar los términos y condiciones de SAS MSE para obtener acceso. Para obtener detalles adicionales, revise las declaraciones de divulgación en https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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