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Durvalumab-behandling i kombinasjon med kjemoterapi og Bevacizumab, etterfulgt av vedlikeholdsbehandling med Durvalumab, Bevacizumab og Olaparib hos avanserte eggstokkreftpasienter (DUO-O)

3. juli 2026 oppdatert av: AstraZeneca

En fase III randomisert, dobbeltblind, placebokontrollert, multisenterstudie av Durvalumab i kombinasjon med kjemoterapi og Bevacizumab, etterfulgt av vedlikehold av Durvalumab, Bevacizumab og Olaparib hos nylig diagnostiserte avanserte eggstokkreftpasienter (DUO-O).

Dette er en fase III randomisert, dobbeltblind multisenterstudie for å evaluere effektiviteten og sikkerheten til durvalumab i kombinasjon med standardbehandling platinabasert kjemoterapi og bevacizumab etterfulgt av vedlikeholdsdurvalumab og bevacizumab eller durvalumab, bevacizumab og olaparib hos pasienter med nylig. diagnostisert avansert eggstokkreft.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Kvalifiserte pasienter vil være de pasientene med nylig diagnostisert, histologisk bekreftet avansert (Fédération Internationale de Gynécologie et d'Obstétrique [FIGO] Stage III-IV) eggstokkreft, primær peritonealkreft og/eller egglederkreft. Alle pasienter bør være kandidater for cytoreduktiv kirurgi som kan utføres som umiddelbar primær kirurgi på forhånd etter diagnose eller kan utføres etter initiering av platinabasert neoadjuvant kjemoterapi. Alle pasienter bør være kvalifisert til å starte førstelinje platinabasert kjemoterapi i kombinasjon med bevacizumab.

Studien tar sikte på å evaluere effektiviteten og sikkerheten av standardbehandling (SoC) platinabasert kjemoterapi og bevacizumab etterfulgt av vedlikeholdsbevacizumab enten som monoterapi, eller i kombinasjon med durvalumab, eller i kombinasjon med durvalumab og olaparib. Derfor har denne studien som mål å se hvilken kombinasjon som gjør at pasienter kan leve lenger uten at kreften kommer tilbake eller blir verre. Studien er også ute etter å se hvilken kombinasjon som gjør at pasientene lever lenger og hvordan behandlingen og kreften påvirker livskvaliteten deres.

Studietype

Intervensjonell

Registrering (Faktiske)

1407

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Belgia
      • Aalst, Belgia, 9300
        • Research Site
      • Leuven, Belgia, 3000
        • Research Site
      • Namur, Belgia, 5000
        • Research Site
      • Ostend, Belgia, 8400
        • Research Site
      • Sint-Niklaas, Belgia, 9100
        • 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
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Research Site
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Research Site
      • Greater Sudbury, Ontario, Canada, P3E 5J1
        • Research Site
      • Toronto, Ontario, Canada, M5G 2M9
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Research Site
      • Montreal, Quebec, Canada, H3T 1E2
        • Research Site
      • Montreal, Quebec, Canada, H2X 3E4
        • Research Site
      • Québec, Quebec, Canada, G1J 1Z4
        • Research Site
      • Rimouski, Quebec, Canada, G5L 5T1
        • Research Site
  • Danmark
      • Aalborg, Danmark, 9000
        • Research Site
      • Aarhus N, Danmark, 8200
        • Research Site
      • Odense, Danmark, 5000
        • Research Site
      • Roskilde, Danmark, 4000
        • Research Site
      • Vejle, Danmark, 7100
        • Research Site
  • Finland
      • Kuopio, Finland, 70210
        • Research Site
      • Oulu, Finland, 90029
        • Research Site
      • Turku, Finland, 20521
        • Research Site
  • Forente stater
    • California
      • Foothill Ranch, California, Forente stater, 92610
        • Research Site
      • Los Angeles, California, Forente stater, 90095
        • Research Site
      • Orange, California, Forente stater, 92868-3298
        • Research Site
      • San Francisco, California, Forente stater, 94158
        • Research Site
    • Florida
      • Tampa, Florida, Forente stater, 33612
        • Research Site
    • Georgia
      • Augusta, Georgia, Forente stater, 30912
        • Research Site
    • Illinois
      • Hinsdale, Illinois, Forente stater, 60521
        • Research Site
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46202
        • Research Site
    • Maryland
      • Towson, Maryland, Forente stater, 21204
        • Research Site
    • Michigan
      • Detroit, Michigan, Forente stater, 48202
        • Research Site
    • Missouri
      • Springfield, Missouri, Forente stater, 65807
        • Research Site
    • New Jersey
      • Middletown, New Jersey, Forente stater, 07748
        • Research Site
      • Montvale, New Jersey, Forente stater, 07645
        • Research Site
    • New York
      • Albany, New York, Forente stater, 12208
        • Research Site
      • New York, New York, Forente stater, 10065
        • Research Site
      • Uniondale, New York, Forente stater, 11553
        • Research Site
    • North Carolina
      • Durham, North Carolina, Forente stater, 27710
        • Research Site
    • Ohio
      • Cleveland, Ohio, Forente stater, 44195
        • Research Site
      • Dayton, Ohio, Forente stater, 45429
        • Research Site
      • Hilliard, Ohio, Forente stater, 43026
        • Research Site
    • Oklahoma
      • Tulsa, Oklahoma, Forente stater, 74134
        • Research Site
    • Pennsylvania
      • Lancaster, Pennsylvania, Forente stater, 17601
        • Research Site
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Research Site
      • Philadelphia, Pennsylvania, Forente stater, 19107-5097
        • Research Site
      • Pittsburgh, Pennsylvania, Forente stater, 15224
        • Research Site
    • Utah
      • Salt Lake City, Utah, Forente stater, 84112
        • Research Site
  • Frankrike
      • Besançon, Frankrike, 25000
        • Research Site
      • Bordeaux, Frankrike, 33076
        • Research Site
      • Limoges, Frankrike, 87042
        • Research Site
      • Lyon, Frankrike, 69373
        • Research Site
      • Marseille, Frankrike, 13273
        • Research Site
      • Nantes, Frankrike, 44202
        • Research Site
      • Paris, Frankrike, 75012
        • Research Site
      • Paris, Frankrike, 75015
        • Research Site
      • Paris, Frankrike, 75674
        • Research Site
      • Saint-Herblain, Frankrike, 44805
        • Research Site
      • Vandœuvre-lès-Nancy, Frankrike, 54519
        • 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
  • Japan
      • Fukuoka, Japan, 811-1395
        • Research Site
      • Kashiwa-shi, Japan, 277-8567
        • Research Site
      • Kobe, Japan, 650-0047
        • Research Site
      • Kurume-shi, Japan, 830-0011
        • Research Site
      • Kyoto, Japan, 606-8507
        • Research Site
      • Kōtoku, Japan, 135-8550
        • Research Site
      • Minatoku, Japan, 105-8471
        • Research Site
      • Nagoya, Japan, 464-8681
        • Research Site
      • Niigata, Japan, 951-8520
        • Research Site
      • Okayama, Japan, 700-8558
        • Research Site
      • Sapporo, Japan, 003-0804
        • Research Site
      • Sendai, Japan, 980-8574
        • Research Site
      • Shinjuku-ku, Japan, 160-8582
        • Research Site
      • Sunto-gun, Japan, 411-8777
        • Research Site
      • Toyoake-shi, Japan, 470-1192
        • Research Site
  • Kina
      • Beijing, Kina, CN-100730
        • Research Site
      • Beijing, Kina, 100026
        • Research Site
      • Bengbu, Kina, 233004
        • Research Site
      • Changchun, Kina, 130021
        • Research Site
      • Changsha, Kina, 410008
        • Research Site
      • Changsha, Kina, 430033
        • Research Site
      • Chengdu, Kina, 610041
        • Research Site
      • Chongqing, Kina, 400030
        • Research Site
      • Dalian, Kina, 116001
        • Research Site
      • Guangzhou, Kina, 510080
        • Research Site
      • Guangzhou, Kina, 510060
        • Research Site
      • Hangzhou, Kina, 310022
        • Research Site
      • Hangzhou, Kina, 310009
        • Research Site
      • Harbin, Kina, 150081
        • Research Site
      • Hefei, Kina, 230031
        • Research Site
      • Jinhua, Kina, 321099
        • Research Site
      • Kunming, Kina, 650118
        • Research Site
      • Lanzhou, Kina, 730030
        • Research Site
      • Luzhou, Kina, 646099
        • Research Site
      • Nanchong, Kina, 637000
        • Research Site
      • Nanjing, Kina, 2100008
        • Research Site
      • Nanning, Kina, 530021
        • Research Site
      • Nantong, Kina, 226361
        • Research Site
      • Shanghai, Kina, 200011
        • Research Site
      • Shanghai, Kina, 200032
        • Research Site
      • Wuhan, Kina, 430030
        • Research Site
      • Wuhan, Kina, 430060
        • Research Site
      • Xi'an, Kina, 710061
        • Research Site
      • Zhengzhou, Kina, 450008
        • Research Site
      • Zhengzhou, Kina, 450002
        • Research Site
      • Zhuhai, Kina, 519099
        • 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
  • Polen
      • Gdynia, Polen, 81-519
        • Research Site
      • Lodz, Polen, 93-513
        • Research Site
      • Szczecin, Polen, 70-111
        • Research Site
      • Warsaw, Polen, 02-781
        • Research Site
      • Warsaw, Polen, 04-141
        • Research Site
  • Romania
      • Floreşti, Romania, 407280
        • Research Site
  • Spania
      • Córdoba, Spania, 14004
        • Research Site
      • Madrid, Spania, 28034
        • Research Site
      • Madrid, Spania, 28041
        • Research Site
      • Madrid, Spania, 28040
        • Research Site
      • Madrid, Spania, 28033
        • Research Site
      • Terrassa(Barcelona), Spania, 08221
        • Research Site
      • Vigo, Spania, 36312
        • Research Site
  • Sør -Korea
      • Goyang-si, Sør -Korea, 10408
        • Research Site
      • Seongnam-si, Sør -Korea, 13620
        • Research Site
      • Seoul, Sør -Korea, 03080
        • Research Site
      • Seoul, Sør -Korea, 03722
        • Research Site
      • Seoul, Sør -Korea, 06351
        • Research Site
      • Suwon, Sør -Korea, 16499
        • Research Site
  • Tyrkia (Türkiye)
      • Adana, Tyrkia (Türkiye), 1260
        • Research Site
      • Ankara, Tyrkia (Türkiye), 06230
        • Research Site
      • Ankara, Tyrkia (Türkiye), 06490
        • Research Site
      • Istanbul, Tyrkia (Türkiye), 34093
        • Research Site
      • Istanbul, Tyrkia (Türkiye), 34384
        • Research Site
      • Izmir, Tyrkia (Türkiye), 35100
        • Research Site
  • Tyskland
      • Bad Homburg, Tyskland, 61352
        • Research Site
      • Berlin, Tyskland, 10117
        • Research Site
      • Bielefeld, Tyskland, 33604
        • Research Site
      • Bonn, Tyskland, 53105
        • Research Site
      • Brandenburg, Tyskland, 14770
        • Research Site
      • Cologne, Tyskland, 50935
        • Research Site
      • Dresden, Tyskland, 1307
        • Research Site
      • Düsseldorf, Tyskland, 40489
        • Research Site
      • Essen, Tyskland, 45136
        • Research Site
      • Essen, Tyskland, 45147
        • Research Site
      • Esslingen am Neckar, Tyskland, 73730
        • Research Site
      • Frankfurt, Tyskland, 60590
        • Research Site
      • Freiburg im Breisgau, Tyskland, 79106
        • Research Site
      • Fürth, Tyskland, 90766
        • Research Site
      • Greifswald, Tyskland, 17475
        • Research Site
      • Gütersloh, Tyskland, 33332
        • Research Site
      • Hamburg, Tyskland, 20246
        • Research Site
      • Hamburg, Tyskland, 20357
        • Research Site
      • Hamburg, Tyskland, 22457
        • Research Site
      • Hanover, Tyskland, 30625
        • Research Site
      • Hanover, Tyskland, 30177
        • Research Site
      • Jena, Tyskland, 07747
        • Research Site
      • Karlsruhe, Tyskland, 76135
        • Research Site
      • Karlsruhe, Tyskland, 76133
        • Research Site
      • Kassel, Tyskland, 34125
        • Research Site
      • Kiel, Tyskland, 24105
        • Research Site
      • Leipzig, Tyskland, 04103
        • Research Site
      • Ludwigsburg, Tyskland, 71640
        • Research Site
      • Lübeck, Tyskland, 23538
        • Research Site
      • Mainz, Tyskland, 55131
        • Research Site
      • Mannheim, Tyskland, 68167
        • Research Site
      • München, Tyskland, 81377
        • Research Site
      • Offenbach, Tyskland, 63069
        • Research Site
      • Oldenburg, Tyskland, 26133
        • Research Site
      • Rosenheim, Tyskland, 83022
        • Research Site
      • Rostock, Tyskland, 18057
        • Research Site
      • Saalfeld, Tyskland, 07318
        • Research Site
      • Schweinfurt, Tyskland, 97422
        • Research Site
      • Tübingen, Tyskland, 72016
        • Research Site
      • Ulm, Tyskland, 89075
        • Research Site
      • Worms, Tyskland, 67550
        • Research Site
  • Ungarn
      • Budapest, Ungarn, 1122
        • Research Site
      • Budapest, Ungarn, 1062
        • Research Site
      • Debrecen, Ungarn, 4032
        • Research Site
      • Győr, Ungarn, 9024
        • Research Site
      • Kaposvár, Ungarn, 7400
        • Research Site
      • Szeged, Ungarn, 6725
        • Research Site
      • Zalaegerszeg, Ungarn, 8900
        • Research Site
  • Østerrike
      • Graz, Østerrike, 8036
        • Research Site
      • Innsbruck, Østerrike, 6020
        • Research Site
      • Linz, Østerrike, 4020
        • Research Site
      • Vienna, Østerrike, 1090
        • Research Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 130 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Beskrivelse

Viktige inkluderingskriterier:

Kvinnelige pasienter med nylig diagnostisert, histologisk bekreftet, avansert (stadium III-IV) høygradig epitelial eggstokkreft inkludert høygradig alvorlig, høygradig endometriod, klarcellet eggstokkreft eller karsinosarkom, primær peritonealkreft og/eller egglederkreft

  • Pasienter må være i alderen ≥18 år. For pasienter registrert i Japan som er i alderen
  • Alle pasienter bør være kandidater for cytoreduktiv kirurgi enten: primærkirurgi på forhånd ELLER planlegger å gjennomgå cellegiftbehandling med intervall debulking kirurgi
  • Bevis på tilstedeværelse eller fravær av BRCA1/2-mutasjon i tumorvev
  • Obligatorisk levering av tumorprøve for sentralisert tBRCA-testing
  • ECOG ytelsesstatus 0-1
  • Pasienter må ha bevart organ- og benmargsfunksjon
  • Postmenopausal eller bevis på ikke-fertil status for kvinner i fertil alder: negativ urin- eller serumgraviditetstest

Nøkkelekskluderingskriterier:

Ikke-epitelial eggstokkreft, borderline svulster, lavgradige epiteliale svulster eller mucinøs histologi

  • Tidligere systemisk anti-kreftbehandling for eggstokkreft
  • Manglende evne til å fastslå tilstedeværelse eller fravær av en skadelig eller mistenkt skadelig BRCA-mutasjon
  • Tidligere behandling med PARP-hemmer eller immunmediert terapi
  • Planlagt intraperitoneal cytotoksisk kjemoterapi
  • Aktive eller tidligere dokumenterte autoimmune eller inflammatoriske lidelser
  • Pasienter betraktet som en dårlig medisinsk risiko på grunn av en alvorlig, ukontrollert sammenfallende sykdom
  • Klinisk signifikant kardiovaskulær sykdom
  • Pasienter med kjente hjernemetastaser

  • Historie om en annen primær malignitet bortsett fra:

    • Malignitet behandlet med kurativ hensikt og uten kjent aktiv sykdom ≥5 år før den første dosen av studiebehandlingen og med lav potensiell risiko for residiv (pasienter som tidligere har fått adjuvant kjemoterapi for tidlig stadium av brystkreft kan være kvalifisert, forutsatt at den ble fullført ≥3 år før registrering, og at pasienten forblir fri for tilbakevendende eller metastatisk sykdom)
    • Tilstrekkelig behandlet ikke-melanom hudkreft eller lentigo maligna uten tegn på sykdom
    • Tilstrekkelig behandlet karsinom in situ uten tegn på sykdom
    • Endometriekreft FIGO stadium IA, grad 1 eller grad 2
  • Vedvarende toksisitet CTCAE Grad >2 forårsaket av tidligere kreftbehandling
  • Pasienter med kjent overfølsomhet overfor olaparib, durvalumab eller noen av hjelpestoffene i disse produktene og for kombinasjons-/sammenligningsmidlene
  • Ammende kvinner

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Arm 1
Platinabasert kjemoterapi i kombinasjon med bevacizumab og durvalumab placebo (saltvannsinfusjon) etterfulgt av vedlikeholdsbevacizumab, durvalumab placebo (saltvannsinfusjon) og olaparib placebo (tabletter).
Legemiddel: Bevacizumab
Bevacizumab ved intravenøs infusjon. I tBRCAm-kohort er bevacizumab valgfritt i henhold til lokal praksis.
Legemiddel: Placebo olaparib
Placebotabletter som matcher olaparib
Legemiddel: Durvalumab placebo
Matchende placebo for intravenøs infusjon
Legemiddel: Karboplatin + paklitaksel
Standard of care kjemoterapi
Eksperimentell: Arm 2
Platinabasert kjemoterapi i kombinasjon med bevacizumab og durvalumab etterfulgt av vedlikeholdsbevacizumab, durvalumab og olaparib placebo.
Legemiddel: Bevacizumab
Bevacizumab ved intravenøs infusjon. I tBRCAm-kohort er bevacizumab valgfritt i henhold til lokal praksis.
Legemiddel: Placebo olaparib
Placebotabletter som matcher olaparib
Legemiddel: Karboplatin + paklitaksel
Standard of care kjemoterapi
Legemiddel: Durvalumab
Durvalumab ved intravenøs infusjon
Eksperimentell: Arm 3
Platinabasert kjemoterapi i kombinasjon med bevacizumab og durvalumab etterfulgt av vedlikeholdsbevacizumab, durvalumab og olaparib.
Legemiddel: Olaparib
Olaparib tabletter
Legemiddel: Bevacizumab
Bevacizumab ved intravenøs infusjon. I tBRCAm-kohort er bevacizumab valgfritt i henhold til lokal praksis.
Legemiddel: Karboplatin + paklitaksel
Standard of care kjemoterapi
Legemiddel: Durvalumab
Durvalumab ved intravenøs infusjon
Eksperimentell: tBRCAm-kohort
Platinabasert kjemoterapi i kombinasjon med bevacizumab og durvalumab etterfulgt av vedlikeholdsbevacizumab, durvalumab og olaparib. Bevacizumab er valgfritt i henhold til lokal praksis.
Legemiddel: Olaparib
Olaparib tabletter
Legemiddel: Bevacizumab
Bevacizumab ved intravenøs infusjon. I tBRCAm-kohort er bevacizumab valgfritt i henhold til lokal praksis.
Legemiddel: Karboplatin + paklitaksel
Standard of care kjemoterapi
Legemiddel: Durvalumab
Durvalumab ved intravenøs infusjon

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression-free Survival (PFS) by Investigator Assessment Using Modified RECIST 1.1 - Full Analysis Set
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression-free Survival (PFS) by Investigator Assessment Using Modified RECIST 1.1 - Full Analysis Set
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Sikkerhet og tolerabilitet av legemidler ved vurdering av AE/SAE
Tidsramme: Omtrent 4 år
Gradert i henhold til National Cancer Institute (NCI CTCAE)
Omtrent 4 år

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

AstraZeneca

Samarbeidspartnere

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

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. januar 2019

Primær fullføring (Faktiske)

17. mars 2025

Studiet fullført (Antatt)

23. desember 2026

Datoer for studieregistrering

Først innsendt

15. oktober 2018

Først innsendt som oppfylte QC-kriteriene

8. november 2018

Først lagt ut (Faktiske)

9. november 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Kvalifiserte forskere kan be om tilgang til anonymiserte individuelle data på pasientnivå fra AstraZeneca gruppe av selskaper sponset kliniske studier via forespørselsportalen. Alle forespørsler vil bli evaluert i henhold til AZ-avsløringsforpliktelsen: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD-delingstidsramme

AstraZeneca vil oppfylle eller overgå datatilgjengelighet i henhold til forpliktelsene som er gitt til EFPIA Pharmas datadelingsprinsipper. For detaljer om tidslinjene våre, vennligst referer til vår avsløringsforpliktelse på https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Tilgangskriterier for IPD-deling

Når en forespørsel er godkjent, vil AstraZeneca gi tilgang til de avidentifiserte individuelle dataene på pasientnivå i et godkjent sponset verktøy. Signert datadelingsavtale (ikke-omsettelig kontrakt for dataaksessors) må være på plass før du får tilgang til forespurt informasjon. I tillegg må alle brukere godta vilkårene og betingelsene til SAS MSE for å få tilgang. For ytterligere detaljer, vennligst se Disclosure Statements på https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

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