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Durvalumabbehandling i kombination med kemoterapi och Bevacizumab, följt av underhållsbehandling med Durvalumab, Bevacizumab och Olaparib hos patienter med avancerad äggstockscancer (DUO-O)

3 juli 2026 uppdaterad av: AstraZeneca

En fas III randomiserad, dubbelblind, placebokontrollerad, multicenterstudie av Durvalumab i kombination med kemoterapi och Bevacizumab, följt av underhåll av Durvalumab, Bevacizumab och Olaparib hos nydiagnostiserade patienter med avancerad ovariecancer (DUO-O).

Detta är en randomiserad, dubbelblind, multicenterstudie i fas III för att utvärdera effektiviteten och säkerheten av durvalumab i kombination med standardbehandling platinabaserad kemoterapi och bevacizumab följt av underhållsbehandling av durvalumab och bevacizumab eller durvalumab, bevacizumab och olaparib hos patienter med nyligen diagnostiserat avancerad äggstockscancer.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Kvalificerade patienter kommer att vara de patienter med nyligen diagnostiserad, histologiskt bekräftad avancerad (Fédération Internationale de Gynécologie et d'Obstétrique [FIGO] Steg III-IV) äggstockscancer, primär peritonealcancer och/eller äggledarcancer. Alla patienter bör vara kandidater för cytoreduktiv kirurgi som kan utföras som omedelbar primär kirurgi i förväg efter diagnos eller kan utföras efter påbörjad platinabaserad neoadjuvant kemoterapi. Alla patienter bör vara berättigade att påbörja första linjens platinabaserad kemoterapi i kombination med bevacizumab.

Studien syftar till att utvärdera effektiviteten och säkerheten av standardbehandling (SoC) platinabaserad kemoterapi och bevacizumab följt av underhållsbevacizumab antingen som monoterapi, eller i kombination med durvalumab, eller i kombination med durvalumab och olaparib. Därför syftar denna studie till att se vilken kombination som gör att patienter kan leva längre utan att cancern kommer tillbaka eller förvärras. Studien vill också se vilken kombination som gör att patienter lever längre och hur behandlingen och cancern påverkar deras livskvalitet.

Studietyp

Interventionell

Inskrivning (Faktisk)

1407

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • 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
  • 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
  • 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
  • Förenta staterna
    • California
      • Foothill Ranch, California, Förenta staterna, 92610
        • Research Site
      • Los Angeles, California, Förenta staterna, 90095
        • Research Site
      • Orange, California, Förenta staterna, 92868-3298
        • Research Site
      • San Francisco, California, Förenta staterna, 94158
        • Research Site
    • Florida
      • Tampa, Florida, Förenta staterna, 33612
        • Research Site
    • Georgia
      • Augusta, Georgia, Förenta staterna, 30912
        • Research Site
    • Illinois
      • Hinsdale, Illinois, Förenta staterna, 60521
        • Research Site
    • Indiana
      • Indianapolis, Indiana, Förenta staterna, 46202
        • Research Site
    • Maryland
      • Towson, Maryland, Förenta staterna, 21204
        • Research Site
    • Michigan
      • Detroit, Michigan, Förenta staterna, 48202
        • Research Site
    • Missouri
      • Springfield, Missouri, Förenta staterna, 65807
        • Research Site
    • New Jersey
      • Middletown, New Jersey, Förenta staterna, 07748
        • Research Site
      • Montvale, New Jersey, Förenta staterna, 07645
        • Research Site
    • New York
      • Albany, New York, Förenta staterna, 12208
        • Research Site
      • New York, New York, Förenta staterna, 10065
        • Research Site
      • Uniondale, New York, Förenta staterna, 11553
        • Research Site
    • North Carolina
      • Durham, North Carolina, Förenta staterna, 27710
        • Research Site
    • Ohio
      • Cleveland, Ohio, Förenta staterna, 44195
        • Research Site
      • Dayton, Ohio, Förenta staterna, 45429
        • Research Site
      • Hilliard, Ohio, Förenta staterna, 43026
        • Research Site
    • Oklahoma
      • Tulsa, Oklahoma, Förenta staterna, 74134
        • Research Site
    • Pennsylvania
      • Lancaster, Pennsylvania, Förenta staterna, 17601
        • Research Site
      • Philadelphia, Pennsylvania, Förenta staterna, 19104
        • Research Site
      • Philadelphia, Pennsylvania, Förenta staterna, 19107-5097
        • Research Site
      • Pittsburgh, Pennsylvania, Förenta staterna, 15224
        • Research Site
    • Utah
      • Salt Lake City, Utah, Förenta staterna, 84112
        • 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
  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada, T2N 5G2
        • Research Site
    • Ontario
      • Barrie, Ontario, Kanada, L4M 6M2
        • Research Site
      • Greater Sudbury, Ontario, Kanada, P3E 5J1
        • Research Site
      • Toronto, Ontario, Kanada, M5G 2M9
        • Research Site
    • Quebec
      • Montreal, Quebec, Kanada, H4A 3J1
        • Research Site
      • Montreal, Quebec, Kanada, H3T 1E2
        • Research Site
      • Montreal, Quebec, Kanada, H2X 3E4
        • Research Site
      • Québec, Quebec, Kanada, G1J 1Z4
        • Research Site
      • Rimouski, Quebec, Kanada, G5L 5T1
        • 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
  • Rumänien
      • Floreşti, Rumänien, 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
  • Turkiet (Türkiye)
      • Adana, Turkiet (Türkiye), 1260
        • Research Site
      • Ankara, Turkiet (Türkiye), 06230
        • Research Site
      • Ankara, Turkiet (Türkiye), 06490
        • Research Site
      • Istanbul, Turkiet (Türkiye), 34093
        • Research Site
      • Istanbul, Turkiet (Türkiye), 34384
        • Research Site
      • Izmir, Turkiet (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
  • Ungern
      • Budapest, Ungern, 1122
        • Research Site
      • Budapest, Ungern, 1062
        • Research Site
      • Debrecen, Ungern, 4032
        • Research Site
      • Győr, Ungern, 9024
        • Research Site
      • Kaposvár, Ungern, 7400
        • Research Site
      • Szeged, Ungern, 6725
        • Research Site
      • Zalaegerszeg, Ungern, 8900
        • Research Site
  • Österrike
      • Graz, Österrike, 8036
        • Research Site
      • Innsbruck, Österrike, 6020
        • Research Site
      • Linz, Österrike, 4020
        • Research Site
      • Vienna, Österrike, 1090
        • Research Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 130 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Beskrivning

Viktiga inkluderingskriterier:

Kvinnliga patienter med nyligen diagnostiserad, histologiskt bekräftad, avancerad (stadium III-IV) höggradig epitelial äggstockscancer inklusive höggradig allvarlig, höggradig endometriod, klarcellig äggstockscancer eller karcinosarkom, primär peritonealcancer och/eller äggledarcancer

  • Patienterna måste vara ≥18 år gamla. För patienter inskrivna i Japan som är äldre
  • Alla patienter bör vara kandidater för cytoreduktiv kirurgi antingen: primär kirurgi i förväg ELLER planerar att genomgå kemoterapi med intervall debulking kirurgi
  • Bevis på närvaro eller frånvaro av BRCA1/2-mutation i tumörvävnad
  • Obligatorisk tillhandahållande av tumörprov för centraliserad tBRCA-testning
  • ECOG prestandastatus 0-1
  • Patienterna måste ha bevarad organ- och benmärgsfunktion
  • Postmenopausal eller tecken på icke-fertil status för kvinnor i fertil ålder: negativt urin- eller serumgraviditetstest

Viktiga uteslutningskriterier:

Icke-epitelial äggstockscancer, borderlinetumörer, låggradiga epiteltumörer eller mucinös histologi

  • Tidigare systemisk anti-cancerterapi för äggstockscancer
  • Oförmåga att fastställa närvaron eller frånvaron av en skadlig eller misstänkt skadlig BRCA-mutation
  • Tidigare behandling med PARP-hämmare eller immunmedierad terapi
  • Planerad intraperitoneal cytotoxisk kemoterapi
  • Aktiva eller tidigare dokumenterade autoimmuna eller inflammatoriska störningar
  • Patienter ansåg en dålig medicinsk risk på grund av en allvarlig, okontrollerad interkurrent sjukdom
  • Kliniskt signifikant hjärt-kärlsjukdom
  • Patienter med kända hjärnmetastaser

  • Historik om en annan primär malignitet förutom:

    • Malignitet behandlad med kurativ avsikt och utan känd aktiv sjukdom ≥ 5 år före den första dosen av studiebehandlingen och med låg potentiell risk för återfall (patienter som tidigare har fått adjuvant kemoterapi för bröstcancer i tidigt stadium kan vara berättigade, förutsatt att den avslutades ≥3 år före registrering, och att patienten förblir fri från återkommande eller metastaserande sjukdom)
    • Adekvat behandlad icke-melanom hudcancer eller lentigo maligna utan tecken på sjukdom
    • Tillräckligt behandlat karcinom in situ utan tecken på sjukdom
    • Endometriecancer FIGO steg IA, grad 1 eller grad 2
  • Ihållande toxicitet CTCAE Grad >2 orsakad av tidigare cancerbehandling
  • Patienter med känd överkänslighet mot olaparib, durvalumab eller något av hjälpämnena i dessa produkter och mot kombinations-/jämförelsemedlen
  • Ammande kvinnor

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Arm 1
Platinabaserad kemoterapi i kombination med bevacizumab och durvalumab placebo (saltlösning IV infusion) följt av underhållsbevacizumab, durvalumab placebo (saltlösning IV infusion) och olaparib placebo (tabletter).
Läkemedel: Bevacizumab
Bevacizumab genom intravenös infusion. I tBRCAm-kohorten är bevacizumab valfritt enligt lokal praxis.
Läkemedel: Placebo olaparib
Placebotabletter för att matcha olaparib
Läkemedel: Durvalumab placebo
Matchande placebo för intravenös infusion
Läkemedel: Karboplatin+Paclitaxel
Standardbehandling med kemoterapi
Experimentell: Arm 2
Platinabaserad kemoterapi i kombination med bevacizumab och durvalumab följt av underhållsbevacizumab, durvalumab och olaparib placebo.
Läkemedel: Bevacizumab
Bevacizumab genom intravenös infusion. I tBRCAm-kohorten är bevacizumab valfritt enligt lokal praxis.
Läkemedel: Placebo olaparib
Placebotabletter för att matcha olaparib
Läkemedel: Karboplatin+Paclitaxel
Standardbehandling med kemoterapi
Läkemedel: Durvalumab
Durvalumab genom intravenös infusion
Experimentell: Arm 3
Platinabaserad kemoterapi i kombination med bevacizumab och durvalumab följt av underhållsbevacizumab, durvalumab och olaparib.
Läkemedel: Olaparib
Olaparib tabletter
Läkemedel: Bevacizumab
Bevacizumab genom intravenös infusion. I tBRCAm-kohorten är bevacizumab valfritt enligt lokal praxis.
Läkemedel: Karboplatin+Paclitaxel
Standardbehandling med kemoterapi
Läkemedel: Durvalumab
Durvalumab genom intravenös infusion
Experimentell: tBRCAm-kohort
Platinabaserad kemoterapi i kombination med bevacizumab och durvalumab följt av underhållsbevacizumab, durvalumab och olaparib. Bevacizumab är valfritt enligt lokal praxis.
Läkemedel: Olaparib
Olaparib tabletter
Läkemedel: Bevacizumab
Bevacizumab genom intravenös infusion. I tBRCAm-kohorten är bevacizumab valfritt enligt lokal praxis.
Läkemedel: Karboplatin+Paclitaxel
Standardbehandling med kemoterapi
Läkemedel: Durvalumab
Durvalumab genom intravenös infusion

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Progression-free Survival (PFS) by Investigator Assessment Using Modified RECIST 1.1 - Full Analysis Set
Tidsram: 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)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Progression-free Survival (PFS) by Investigator Assessment Using Modified RECIST 1.1 - Full Analysis Set
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Läkemedels säkerhet och tolerabilitet genom bedömning av biverkningar/SAE
Tidsram: Cirka 4 år
Betygsatt enligt National Cancer Institute (NCI CTCAE)
Cirka 4 år

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

AstraZeneca

Samarbetspartners

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

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

4 januari 2019

Primärt slutförande (Faktisk)

17 mars 2025

Avslutad studie (Beräknad)

23 december 2026

Studieregistreringsdatum

Först inskickad

15 oktober 2018

Först inskickad som uppfyllde QC-kriterierna

8 november 2018

Första postat (Faktisk)

9 november 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

7 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Kvalificerade forskare kan begära tillgång till anonymiserade individuella data på patientnivå från AstraZeneca-gruppen av företag sponsrade kliniska prövningar via förfrågningsportalen. Alla förfrågningar kommer att utvärderas enligt åtagandet för AZ-avslöjande: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Tidsram för IPD-delning

AstraZeneca kommer att uppfylla eller överträffa datatillgängligheten enligt de åtaganden som gjorts enligt EFPIA Pharmas principer för datadelning. För detaljer om våra tidslinjer, vänligen hänvisa till vårt avslöjandeåtagande på https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Kriterier för IPD Sharing Access

När en begäran har godkänts kommer AstraZeneca att ge tillgång till de avidentifierade individuella data på patientnivå i ett godkänt sponsrat verktyg. Undertecknat avtal om datadelning (icke förhandlingsbart avtal för dataåtkomst) måste finnas på plats innan du får åtkomst till begärd information. Dessutom måste alla användare acceptera villkoren för SAS MSE för att få åtkomst. För ytterligare information, vänligen granska Disclosure Statements på https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Ja

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