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Durvalumab-behandling i kombination med kemoterapi og Bevacizumab, efterfulgt af vedligeholdelsesbehandling med Durvalumab, Bevacizumab og Olaparib hos patienter med fremskreden ovariecancer (DUO-O)

3. juli 2026 opdateret af: AstraZeneca

Et fase III randomiseret, dobbeltblindt, placebokontrolleret, multicenterstudie af Durvalumab i kombination med kemoterapi og Bevacizumab, efterfulgt af vedligeholdelse af Durvalumab, Bevacizumab og Olaparib hos nydiagnosticerede avancerede ovariecancerpatienter (DUO-O).

Dette er et fase III randomiseret, dobbelt-blindt, multicenter studie for at evaluere effektiviteten og sikkerheden af ​​durvalumab i kombination med standardbehandling platinbaseret kemoterapi og bevacizumab efterfulgt af vedligeholdelsesdurvalumab og bevacizumab eller durvalumab, bevacizumab og olaparib hos patienter med nyligt diagnosticeret fremskreden kræft i æggestokkene.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Berettigede patienter vil være de patienter med nyligt diagnosticeret, histologisk bekræftet fremskreden (Fédération Internationale de Gynécologie et d'Obstétrique [FIGO] Stage III-IV) ovariecancer, primær peritoneal cancer og/eller æggeledercancer. Alle patienter bør være kandidater til cytoreduktiv kirurgi, som kan udføres som umiddelbar primær operation efter diagnosen eller kan udføres efter påbegyndelse af platinbaseret neoadjuverende kemoterapi. Alle patienter bør være berettiget til at starte førstelinje platinbaseret kemoterapi i kombination med bevacizumab.

Studiet har til formål at evaluere effektiviteten og sikkerheden af ​​standardbehandling (SoC) platinbaseret kemoterapi og bevacizumab efterfulgt af vedligeholdelsesbevacizumab enten som monoterapi eller i kombination med durvalumab eller i kombination med durvalumab og olaparib. Derfor har denne undersøgelse til formål at se, hvilken kombination der gør, at patienter kan leve længere, uden at kræften vender tilbage eller forværres. Undersøgelsen søger også at se, hvilken kombination der får patienterne til at leve længere, og hvordan behandlingen og kræften påvirker deres livskvalitet.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1407

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Belgien
      • Aalst, Belgien, 9300
        • Research Site
      • Leuven, Belgien, 3000
        • Research Site
      • Namur, Belgien, 5000
        • Research Site
      • Ostend, Belgien, 8400
        • Research Site
      • Sint-Niklaas, Belgien, 9100
        • Research Site
  • Brasilien
      • Barretos, Brasilien, 14784-400
        • Research Site
      • Florianópolis, Brasilien, 88034-000
        • Research Site
      • Fortaleza, Brasilien, 60810-180
        • Research Site
      • Londrina, Brasilien, 86015-520
        • Research Site
      • Porto Alegre, Brasilien, 90020-090
        • Research Site
      • Porto Alegre, Brasilien, 90110-270
        • Research Site
      • Rio de Janeiro, Brasilien, 20220-410
        • Research Site
      • São Paulo, Brasilien, 01317-000
        • Research Site
      • São Paulo, Brasilien, 04014-002
        • Research Site
  • Bulgarien
      • Burgas, Bulgarien, 8000
        • Research Site
      • Plovdiv, Bulgarien, 4004
        • Research Site
      • Sofia, Bulgarien, 1330
        • Research Site
      • Varna, Bulgarien, 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
  • Forenede Stater
    • California
      • Foothill Ranch, California, Forenede Stater, 92610
        • Research Site
      • Los Angeles, California, Forenede Stater, 90095
        • Research Site
      • Orange, California, Forenede Stater, 92868-3298
        • Research Site
      • San Francisco, California, Forenede Stater, 94158
        • Research Site
    • Florida
      • Tampa, Florida, Forenede Stater, 33612
        • Research Site
    • Georgia
      • Augusta, Georgia, Forenede Stater, 30912
        • Research Site
    • Illinois
      • Hinsdale, Illinois, Forenede Stater, 60521
        • Research Site
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Research Site
    • Maryland
      • Towson, Maryland, Forenede Stater, 21204
        • Research Site
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48202
        • Research Site
    • Missouri
      • Springfield, Missouri, Forenede Stater, 65807
        • Research Site
    • New Jersey
      • Middletown, New Jersey, Forenede Stater, 07748
        • Research Site
      • Montvale, New Jersey, Forenede Stater, 07645
        • Research Site
    • New York
      • Albany, New York, Forenede Stater, 12208
        • Research Site
      • New York, New York, Forenede Stater, 10065
        • Research Site
      • Uniondale, New York, Forenede Stater, 11553
        • Research Site
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Research Site
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Research Site
      • Dayton, Ohio, Forenede Stater, 45429
        • Research Site
      • Hilliard, Ohio, Forenede Stater, 43026
        • Research Site
    • Oklahoma
      • Tulsa, Oklahoma, Forenede Stater, 74134
        • Research Site
    • Pennsylvania
      • Lancaster, Pennsylvania, Forenede Stater, 17601
        • Research Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Research Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19107-5097
        • Research Site
      • Pittsburgh, Pennsylvania, Forenede Stater, 15224
        • Research Site
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84112
        • Research Site
  • Frankrig
      • Besançon, Frankrig, 25000
        • Research Site
      • Bordeaux, Frankrig, 33076
        • Research Site
      • Limoges, Frankrig, 87042
        • Research Site
      • Lyon, Frankrig, 69373
        • Research Site
      • Marseille, Frankrig, 13273
        • Research Site
      • Nantes, Frankrig, 44202
        • Research Site
      • Paris, Frankrig, 75012
        • Research Site
      • Paris, Frankrig, 75015
        • Research Site
      • Paris, Frankrig, 75674
        • Research Site
      • Saint-Herblain, Frankrig, 44805
        • Research Site
      • Vandœuvre-lès-Nancy, Frankrig, 54519
        • Research Site
  • Italien
      • Brescia, Italien, 25123
        • Research Site
      • Lecce, Italien, 73100
        • Research Site
      • Lecco, Italien, 23900
        • Research Site
      • Milan, Italien, 20141
        • Research Site
      • Milan, Italien, 20132
        • Research Site
      • Mirano, Italien, 30035
        • Research Site
      • Naples, Italien, 80131
        • Research Site
      • Reggio Calabria, Italien, 89100
        • Research Site
      • Reggio Emilia, Italien, 42100
        • Research Site
      • Roma, Italien, 00168
        • Research Site
      • Torino, Italien, 10126
        • Research Site
      • Torino, Italien, 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
  • Rumænien
      • Floreşti, Rumænien, 407280
        • Research Site
  • Spanien
      • Córdoba, Spanien, 14004
        • Research Site
      • Madrid, Spanien, 28034
        • Research Site
      • Madrid, Spanien, 28041
        • Research Site
      • Madrid, Spanien, 28040
        • Research Site
      • Madrid, Spanien, 28033
        • Research Site
      • Terrassa(Barcelona), Spanien, 08221
        • Research Site
      • Vigo, Spanien, 36312
        • Research Site
  • Sydkorea
      • Goyang-si, Sydkorea, 10408
        • Research Site
      • Seongnam-si, Sydkorea, 13620
        • Research Site
      • Seoul, Sydkorea, 03080
        • Research Site
      • Seoul, Sydkorea, 03722
        • Research Site
      • Seoul, Sydkorea, 06351
        • Research Site
      • Suwon, Sydkorea, 16499
        • Research Site
  • Tyrkiet (Türkiye)
      • Adana, Tyrkiet (Türkiye), 1260
        • Research Site
      • Ankara, Tyrkiet (Türkiye), 06230
        • Research Site
      • Ankara, Tyrkiet (Türkiye), 06490
        • Research Site
      • Istanbul, Tyrkiet (Türkiye), 34093
        • Research Site
      • Istanbul, Tyrkiet (Türkiye), 34384
        • Research Site
      • Izmir, Tyrkiet (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
  • Østrig
      • Graz, Østrig, 8036
        • Research Site
      • Innsbruck, Østrig, 6020
        • Research Site
      • Linz, Østrig, 4020
        • Research Site
      • Vienna, Østrig, 1090
        • Research Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 130 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Nøgleinklusionskriterier:

Kvindelige patienter med nyligt diagnosticeret, histologisk bekræftet, fremskreden (stadium III-IV) højgradig epitelial ovariecancer, herunder højgradig alvorlig, højgradig endometriod, klarcellet ovariecancer eller carcinosarkom, primær peritoneal cancer og/eller æggeledercancer

  • Patienterne skal være i alderen ≥18 år. For patienter indskrevet i Japan, der er i alderen
  • Alle patienter bør være kandidater til cytoreduktiv kirurgi enten: Primær kirurgi på forhånd ELLER planlægger at gennemgå kemoterapi med interval debulking kirurgi
  • Bevis på tilstedeværelse eller fravær af BRCA1/2-mutation i tumorvæv
  • Obligatorisk levering af tumorprøve til centraliseret tBRCA-testning
  • ECOG ydeevne status 0-1
  • Patienterne skal have bevaret organ- og knoglemarvsfunktion
  • Postmenopausal eller tegn på ikke-fertil status for kvinder i den fødedygtige alder: negativ urin- eller serumgraviditetstest

Nøgleekskluderingskriterier:

Ikke-epitelial ovariecancer, borderline tumorer, lavgradige epiteltumorer eller mucinøs histologi

  • Tidligere systemisk anti-cancer terapi for ovariecancer
  • Manglende evne til at bestemme tilstedeværelsen eller fraværet af en skadelig eller mistænkt skadelig BRCA-mutation
  • Forudgående behandling med PARP-hæmmer eller immunmedieret terapi
  • Planlagt intraperitoneal cytotoksisk kemoterapi
  • Aktive eller tidligere dokumenterede autoimmune eller inflammatoriske lidelser
  • Patienter betragtede som en ringe medicinsk risiko på grund af en alvorlig, ukontrolleret sammenfaldende sygdom
  • Klinisk signifikant kardiovaskulær sygdom
  • Patienter med kendte hjernemetastaser

  • Anamnese med en anden primær malignitet bortset fra:

    • Malignitet behandlet med kurativ hensigt og uden kendt aktiv sygdom ≥5 år før den første dosis af undersøgelsesbehandling og med lav potentiel risiko for recidiv (patienter, der tidligere har modtaget adjuverende kemoterapi for tidligt stadie af brystkræft, kan være berettiget, forudsat at den blev afsluttet ≥3 år før registrering, og at patienten forbliver fri for tilbagevendende eller metastatisk sygdom)
    • Tilstrækkeligt behandlet ikke-melanom hudkræft eller lentigo maligna uden tegn på sygdom
    • Tilstrækkeligt behandlet carcinom in situ uden tegn på sygdom
    • Endometriecancer FIGO trin IA, grad 1 eller grad 2
  • Vedvarende toksicitet CTCAE Grade >2 forårsaget af tidligere cancerbehandling
  • Patienter med kendt overfølsomhed over for olaparib, durvalumab eller et eller flere af hjælpestofferne i disse produkter og over for kombinations-/sammenligningsmidlerne
  • Ammende kvinder

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Arm 1
Platinbaseret kemoterapi i kombination med bevacizumab og durvalumab placebo (saltvandsinfusion) efterfulgt af vedligeholdelsesbevacizumab, durvalumab placebo (saltvandsinfusion) og olaparib placebo (tabletter).
Medicin: Bevacizumab
Bevacizumab ved intravenøs infusion. I tBRCAm-kohorte er bevacizumab valgfrit i henhold til lokal praksis.
Medicin: Placebo olaparib
Placebotabletter, der matcher olaparib
Medicin: Durvalumab placebo
Matchende placebo til intravenøs infusion
Medicin: Carboplatin+Paclitaxel
Standard of care kemoterapi
Eksperimentel: Arm 2
Platinbaseret kemoterapi i kombination med bevacizumab og durvalumab efterfulgt af vedligeholdelsesbevacizumab, durvalumab og olaparib placebo.
Medicin: Bevacizumab
Bevacizumab ved intravenøs infusion. I tBRCAm-kohorte er bevacizumab valgfrit i henhold til lokal praksis.
Medicin: Placebo olaparib
Placebotabletter, der matcher olaparib
Medicin: Carboplatin+Paclitaxel
Standard of care kemoterapi
Medicin: Durvalumab
Durvalumab ved intravenøs infusion
Eksperimentel: Arm 3
Platinbaseret kemoterapi i kombination med bevacizumab og durvalumab efterfulgt af vedligeholdelsesbevacizumab, durvalumab og olaparib.
Medicin: Olaparib
Olaparib tabletter
Medicin: Bevacizumab
Bevacizumab ved intravenøs infusion. I tBRCAm-kohorte er bevacizumab valgfrit i henhold til lokal praksis.
Medicin: Carboplatin+Paclitaxel
Standard of care kemoterapi
Medicin: Durvalumab
Durvalumab ved intravenøs infusion
Eksperimentel: tBRCAm-kohorte
Platinbaseret kemoterapi i kombination med bevacizumab og durvalumab efterfulgt af vedligeholdelsesbevacizumab, durvalumab og olaparib. Bevacizumab er valgfrit i henhold til lokal praksis.
Medicin: Olaparib
Olaparib tabletter
Medicin: Bevacizumab
Bevacizumab ved intravenøs infusion. I tBRCAm-kohorte er bevacizumab valgfrit i henhold til lokal praksis.
Medicin: Carboplatin+Paclitaxel
Standard of care kemoterapi
Medicin: Durvalumab
Durvalumab ved intravenøs infusion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
Tidsramme
Sikkerhed og tolerabilitet af lægemidler ved vurdering af AE'er/SAE'er
Tidsramme: Cirka 4 år
Bedømt i henhold til National Cancer Institute (NCI CTCAE)
Cirka 4 år

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AstraZeneca

Samarbejdspartnere

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

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. januar 2019

Primær færdiggørelse (Faktiske)

17. marts 2025

Studieafslutning (Anslået)

23. december 2026

Datoer for studieregistrering

Først indsendt

15. oktober 2018

Først indsendt, der opfyldte QC-kriterier

8. november 2018

Først opslået (Faktiske)

9. november 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Kvalificerede forskere kan anmode om adgang til anonymiserede individuelle data på patientniveau fra AstraZeneca gruppe af virksomheder sponsoreret kliniske forsøg via anmodningsportalen. Alle anmodninger vil blive evalueret i henhold til AZ-offentliggørelsesforpligtelsen: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD-delingstidsramme

AstraZeneca vil opfylde eller overgå datatilgængeligheden i henhold til forpligtelserne i henhold til EFPIA Pharmas datadelingsprincipper. For detaljer om vores tidslinjer henvises til vores offentliggørelsesforpligtelse på https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD-delingsadgangskriterier

Når en anmodning er blevet godkendt, giver AstraZeneca adgang til de afidentificerede individuelle data på patientniveau i et godkendt sponsoreret værktøj. Underskrevet datadelingsaftale (ikke-omsættelig kontrakt for dataadgangere) skal være på plads, før du får adgang til de ønskede oplysninger. Derudover skal alle brugere acceptere vilkårene og betingelserne for SAS MSE for at få adgang. For yderligere detaljer, bedes du læse oplysningserklæringerne på https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Avanceret ovariecancer

Kliniske forsøg med Olaparib

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Macedonia

Betingelser

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