Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Trattamento con durvalumab in combinazione con chemioterapia e bevacizumab, seguito da trattamento di mantenimento con durvalumab, bevacizumab e olaparib in pazienti con carcinoma ovarico avanzato (DUO-O)

3 luglio 2026 aggiornato da: AstraZeneca

Uno studio di fase III randomizzato, in doppio cieco, controllato con placebo, multicentrico su durvalumab in combinazione con chemioterapia e bevacizumab, seguito da durvalumab di mantenimento, bevacizumab e olaparib in pazienti con carcinoma ovarico avanzato di nuova diagnosi (DUO-O).

Questo è uno studio di fase III randomizzato, in doppio cieco, multicentrico per valutare l'efficacia e la sicurezza di durvalumab in combinazione con chemioterapia standard a base di platino e bevacizumab seguita da durvalumab e bevacizumab di mantenimento o durvalumab, bevacizumab e olaparib in pazienti con nuova diagnosi di carcinoma ovarico avanzato.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

I pazienti eleggibili saranno quei pazienti con carcinoma ovarico primario, carcinoma peritoneale primario e/o carcinoma delle tube di Falloppio di nuova diagnosi, confermato istologicamente avanzato (Fédération Internationale de Gynécologie et d'Obstétrique [FIGO] Stadio III-IV). Tutti i pazienti devono essere candidati alla chirurgia citoriduttiva che potrebbe essere condotta come intervento chirurgico primario immediato dopo la diagnosi o può essere condotta dopo l'inizio della chemioterapia neoadiuvante a base di platino. Tutti i pazienti dovrebbero essere idonei a iniziare la chemioterapia di prima linea a base di platino in combinazione con bevacizumab.

Lo studio mira a valutare l'efficacia e la sicurezza della chemioterapia standard a base di platino (SoC) e bevacizumab seguita da bevacizumab di mantenimento in monoterapia o in combinazione con durvalumab o in combinazione con durvalumab e olaparib. Pertanto, questo studio mira a vedere quale combinazione consente ai pazienti di vivere più a lungo senza che il cancro si ripresenti o peggiori. Lo studio sta anche cercando di vedere quale combinazione fa vivere più a lungo i pazienti e in che modo il trattamento e il cancro influiscono sulla loro qualità di vita.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1407

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 130 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Descrizione

Criteri chiave di inclusione:

Pazienti di sesso femminile con carcinoma ovarico epiteliale di alto grado (stadio III-IV) di nuova diagnosi, confermato istologicamente, incluso carcinoma ovarico a cellule chiare o carcinosarcoma, carcinoma peritoneale primario e/o carcinoma delle tube di Falloppio

  • I pazienti devono avere un'età ≥18 anni. Per i pazienti arruolati in Giappone che sono anziani
  • Tutti i pazienti devono essere candidati alla chirurgia citoriduttiva: chirurgia primaria iniziale OPPURE pianificare di sottoporsi a chemioterapia con chirurgia di debulking a intervalli
  • Evidenza di presenza o assenza di mutazione BRCA1/2 nel tessuto tumorale
  • Fornitura obbligatoria di campioni di tumore per test tBRCA centralizzati
  • Stato delle prestazioni ECOG 0-1
  • I pazienti devono avere una funzione preservata degli organi e del midollo osseo
  • Postmenopausa o evidenza di stato non fertile per le donne in età fertile: test di gravidanza su urine o siero negativo

Criteri chiave di esclusione:

Cancro ovarico non epiteliale, tumori borderline, tumori epiteliali di basso grado o istologia mucinosa

  • Precedente terapia antitumorale sistemica per carcinoma ovarico
  • Incapacità di determinare la presenza o l'assenza di una mutazione BRCA deleteria o sospetta
  • Precedente trattamento con inibitore di PARP o terapia immuno-mediata
  • Chemioterapia citotossica intraperitoneale pianificata
  • Disturbi autoimmuni o infiammatori attivi o precedentemente documentati
  • Pazienti considerati a basso rischio medico a causa di una malattia intercorrente grave e incontrollata
  • Malattie cardiovascolari clinicamente significative
  • Pazienti con metastasi cerebrali note

  • Storia di un altro tumore maligno primitivo ad eccezione di:

    • Tumori maligni trattati con intento curativo e senza malattia attiva nota ≥5 anni prima della prima dose del trattamento in studio e a basso rischio potenziale di recidiva (i pazienti che hanno ricevuto una precedente chemioterapia adiuvante per carcinoma mammario in stadio iniziale possono essere ammissibili, a condizione che sia stata completata ≥3 anni prima della registrazione e che il paziente rimane libero da malattia ricorrente o metastatica)
    • Cancro della pelle non melanoma adeguatamente trattato o lentigo maligna senza evidenza di malattia
    • Carcinoma in situ adeguatamente trattato senza evidenza di malattia
    • Cancro endometriale FIGO Stadio IA, Grado 1 o Grado 2
  • Tossicità persistenti Grado CTCAE >2 causate da precedente terapia antitumorale
  • Pazienti con nota ipersensibilità a olaparib, durvalumab o ad uno qualsiasi degli eccipienti di questi prodotti e agli agenti di combinazione/di confronto
  • Donne che allattano

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Braccio 1
Chemioterapia a base di platino in combinazione con bevacizumab e durvalumab placebo (infusione endovenosa salina) seguita da bevacizumab di mantenimento, placebo durvalumab (infusione endovenosa salina) e placebo olaparib (compresse).
Droga: Bevacizumab
Bevacizumab per infusione endovenosa. Nella coorte tBRCAm bevacizumab è facoltativo secondo la pratica locale.
Droga: Placebo olaparib
Compresse di placebo per abbinare olaparib
Droga: Durvalumab placebo
Placebo corrispondente per infusione endovenosa
Droga: Carboplatino+Paclitaxel
Chemioterapia standard di cura
Sperimentale: Braccio 2
Chemioterapia a base di platino in combinazione con bevacizumab e durvalumab seguita da bevacizumab di mantenimento, durvalumab e olaparib placebo.
Droga: Bevacizumab
Bevacizumab per infusione endovenosa. Nella coorte tBRCAm bevacizumab è facoltativo secondo la pratica locale.
Droga: Placebo olaparib
Compresse di placebo per abbinare olaparib
Droga: Carboplatino+Paclitaxel
Chemioterapia standard di cura
Droga: Durvalumab
Durvalumab per infusione endovenosa
Sperimentale: Braccio 3
Chemioterapia a base di platino in combinazione con bevacizumab e durvalumab seguita da bevacizumab di mantenimento, durvalumab e olaparib.
Droga: Olaparib
Olaparib compresse
Droga: Bevacizumab
Bevacizumab per infusione endovenosa. Nella coorte tBRCAm bevacizumab è facoltativo secondo la pratica locale.
Droga: Carboplatino+Paclitaxel
Chemioterapia standard di cura
Droga: Durvalumab
Durvalumab per infusione endovenosa
Sperimentale: coorte tBRCAm
Chemioterapia a base di platino in combinazione con bevacizumab e durvalumab seguita da bevacizumab di mantenimento, durvalumab e olaparib. Bevacizumab è facoltativo secondo la pratica locale.
Droga: Olaparib
Olaparib compresse
Droga: Bevacizumab
Bevacizumab per infusione endovenosa. Nella coorte tBRCAm bevacizumab è facoltativo secondo la pratica locale.
Droga: Carboplatino+Paclitaxel
Chemioterapia standard di cura
Droga: Durvalumab
Durvalumab per infusione endovenosa

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-free Survival (PFS) by Investigator Assessment Using Modified RECIST 1.1 - Full Analysis Set
Lasso di tempo: 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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-free Survival (PFS) by Investigator Assessment Using Modified RECIST 1.1 - Full Analysis Set
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Sicurezza e tollerabilità dei farmaci mediante valutazione di eventi avversi/SAE
Lasso di tempo: Circa 4 anni
Classificato secondo il National Cancer Institute (NCI CTCAE)
Circa 4 anni

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

AstraZeneca

Collaboratori

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

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

4 gennaio 2019

Completamento primario (Effettivo)

17 marzo 2025

Completamento dello studio (Stimato)

23 dicembre 2026

Date di iscrizione allo studio

Primo inviato

15 ottobre 2018

Primo inviato che soddisfa i criteri di controllo qualità

8 novembre 2018

Primo Inserito (Effettivo)

9 novembre 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

I ricercatori qualificati possono richiedere l'accesso a dati anonimizzati a livello di singolo paziente dal gruppo di società AstraZeneca sponsorizzate da studi clinici tramite il portale delle richieste. Tutte le richieste saranno valutate secondo l'impegno di divulgazione AZ: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Periodo di condivisione IPD

AstraZeneca soddisferà o supererà la disponibilità dei dati in base agli impegni presi ai principi di condivisione dei dati farmaceutici EFPIA. Per i dettagli delle nostre tempistiche, fare riferimento al nostro impegno di divulgazione su https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Criteri di accesso alla condivisione IPD

Quando una richiesta è stata approvata, AstraZeneca fornirà l'accesso ai dati anonimi a livello di singolo paziente in uno strumento sponsorizzato approvato. L'accordo di condivisione dei dati firmato (contratto non negoziabile per gli accessi ai dati) deve essere in vigore prima di accedere alle informazioni richieste. Inoltre, tutti gli utenti dovranno accettare i termini e le condizioni del SAS MSE per ottenere l'accesso. Per ulteriori dettagli, consultare le dichiarazioni di divulgazione su https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Cancro ovarico avanzato

Prove cliniche su Olaparib

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Malta

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi