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Onderzoek naar Volrustomig bij vrouwen met een hoog risico op lokaal gevorderde baarmoederhalskanker (eVOLVE-Cervical) (eVOLVECervical)

29 september 2026 bijgewerkt door: AstraZeneca

Een fase III, gerandomiseerde, dubbelblinde, placebogecontroleerde, multicentrische, mondiale studie naar Volrustomig bij vrouwen met een hoog risico op lokaal gevorderde baarmoederhalskanker bij wie geen vooruitgang is geboekt na op platina gebaseerde, gelijktijdige chemoradiatietherapie (eVOLVE-cervicaal)

This is a phase III, randomized, double-blind, placebo-controlled, multi-center, global study to explore the efficacy and safety of volrustomig in women with high-risk LACC (FIGO 2018 stage IIIA to IVA cervical cancer) who have not progressed following platinum-based CCRT.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Women with locally advanced cervical cancer will be randomized in a 1:1 ratio to receive treatment with Volrustomig or Placebo.

Studietype

Ingrijpend

Inschrijving (Geschat)

800

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Brazilië
      • Barretos, Brazilië, 14784-400
        • Werving
        • Research Site
      • Belo Horizonte, Brazilië, 30130-100
        • Werving
        • Research Site
      • Curitiba, Brazilië, 80730-150
        • Werving
        • Research Site
      • Fortaleza, Brazilië, 60430-230
        • Werving
        • Research Site
      • Fortaleza, Brazilië, 60336-045
        • Werving
        • Research Site
      • Goiânia, Brazilië, 74110-060
        • Nog niet aan het werven
        • Research Site
      • Ijuí, Brazilië, 98700-000
        • Nog niet aan het werven
        • Research Site
      • Natal, Brazilië, 59075-740
        • Werving
        • Research Site
      • Porto Alegre, Brazilië, 90619-900
        • Werving
        • Research Site
      • Porto Alegre, Brazilië, 98850-170
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        • Research Site
      • Porto Alegre, Brazilië, 90570-060
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        • Research Site
      • Porto Velho, Brazilië, 76834-899
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        • Research Site
      • Recife, Brazilië, 52010-075
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        • Research Site
      • Rio de Janeiro, Brazilië, 20220-410
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        • Research Site
      • Salvador, Brazilië, 40050 410
        • Werving
        • Research Site
      • São Paulo, Brazilië, 01246-000
        • Werving
        • Research Site
      • São Paulo, Brazilië, 1323001
        • Werving
        • Research Site
      • São Paulo, Brazilië, 01323-000
        • Nog niet aan het werven
        • Research Site
      • Teresina, Brazilië, 64049-200
        • Werving
        • Research Site
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 1C3
        • Werving
        • Research Site
      • London, Ontario, Canada, N6A 5W9
        • Ingetrokken
        • Research Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Werving
        • Research Site
      • Toronto, Ontario, Canada, M5G 2M9
        • Werving
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
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        • Research Site
      • Montreal, Quebec, Canada, H2X 0C1
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        • Research Site
      • Ste-Foy, Quebec, Canada, G1V 4G2
        • Ingetrokken
        • Research Site
  • China
      • Beijing, China, 100730
        • Werving
        • Research Site
      • Beijing, China, 100142
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        • Research Site
      • Beijing, China, 100026
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        • Research Site
      • Changde, China, 415000
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        • Research Site
      • Changsha, China, 410008
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        • Research Site
      • Changsha, China, 410013
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        • Research Site
      • Chengdu, China, 610041
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        • Research Site
      • Chengdu, China, 610044
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        • Research Site
      • Chongqing, China, 400030
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        • Research Site
      • Fuzhou, China, 350014
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        • Research Site
      • Ganzhou, China, 341000
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        • Research Site
      • Guangzhou, China, 510060
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        • Research Site
      • Guangzhou, China, 510120
        • Ingetrokken
        • Research Site
      • Hangzhou, China, 310022
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        • Research Site
      • Harbin, China, 150081
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        • Research Site
      • Kunming, China, 650118
        • Werving
        • Research Site
      • Lanzhou, China, 730050
        • Werving
        • Research Site
      • Lanzhou, China, 730000
        • Voltooid
        • Research Site
      • Linyi, China, 276001
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        • Research Site
      • Luzhou, China, 646000
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        • Research Site
      • Nanchang, China, 330006
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        • Research Site
      • Nanchang, China, 330029
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        • Research Site
      • Shandong, China
        • Ingetrokken
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      • Shanghai, China, 200032
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      • Shanghai, China, 200080
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        • Research Site
      • Shenyang, China, 110004
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      • Shenzhen, China, 518036
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        • Research Site
      • Shenzhen, China, 518116
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      • Tianjin, China, 300060
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        • Research Site
      • Wuhan, China, 430022
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        • Research Site
      • Wuhan, China, 430030
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        • Research Site
      • Xi'an, China, 710061
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        • Research Site
      • Yibin, China, 610500
        • Ingetrokken
        • Research Site
      • Yinchuan, China, 750004
        • Werving
        • Research Site
      • Zhengzhou, China, 450008
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        • Research Site
      • Zhengzhou, China, 450052
        • Beëindigd
        • Research Site
      • Zhuzhou, China, 412007
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  • Denemarken
      • Aarhus N, Denemarken, 8200
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        • Research Site
      • København Ø, Denemarken, 2100
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        • Research Site
      • Odense, Denemarken, 5000
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        • Research Site
  • Duitsland
      • Berlin, Duitsland, 13353
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        • Research Site
      • Bonn, Duitsland, 53127
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        • Research Site
      • Hamburg, Duitsland, 20246
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      • Leipzig, Duitsland, 04103
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  • Indië
      • Calicut, Indië, 673601
        • Beëindigd
        • Research Site
      • Jaipur, Indië, 302017
        • Werving
        • Research Site
      • Lucknow, Indië, 226003
        • Ingetrokken
        • Research Site
      • Madurai, Indië, 625107
        • Werving
        • Research Site
      • Mohali, Indië, 160055
        • Ingetrokken
        • Research Site
      • Nagpur, Indië, 440001
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        • Research Site
      • Nashik, Indië, 422009
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        • Research Site
      • Nashik, Indië, 422011
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        • Research Site
      • New Delhi, Indië, 110029
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        • Research Site
      • Vadodara, Indië, 391760
        • Werving
        • Research Site
  • Italië
      • Bari, Italië, 70124
        • Ingetrokken
        • Research Site
      • Bologna, Italië, 40138
        • Werving
        • Research Site
      • Catania, Italië, 95126
        • Werving
        • Research Site
      • Florence, Italië, 50141
        • Werving
        • Research Site
      • Lecco, Italië, 23900
        • Voltooid
        • Research Site
      • Milan, Italië, 20141
        • Werving
        • Research Site
      • Milan, Italië, 20159
        • Werving
        • Research Site
      • Milan, Italië, 20133
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        • Research Site
      • Monza, Italië, 20900
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        • Research Site
      • Naples, Italië, 80131
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        • Research Site
      • Roma, Italië, 161
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      • Rome, Italië, 00168
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        • Research Site
      • Turin, Italië, 10128
        • Werving
        • Research Site
  • Japan
      • Fukuoka, Japan, 812-8582
        • Werving
        • Research Site
      • Ginowan-shi, Japan, 901-2725
        • Werving
        • Research Site
      • Hidaka-shi, Japan, 350-1298
        • Werving
        • Research Site
      • Kagoshima, Japan, 890-8520
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        • Research Site
      • Kurume-shi, Japan, 830-0011
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        • Research Site
      • Kōtoku, Japan, 135-8550
        • Werving
        • Research Site
      • Maebashi, Japan, 371-8511
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        • Research Site
      • Matsuyama, Japan, 791-0280
        • Werving
        • Research Site
      • Morioka, Japan, 028-3695
        • Werving
        • Research Site
      • Nagoya, Japan, 464-8681
        • Werving
        • Research Site
      • Osaka, Japan, 541-8567
        • Ingetrokken
        • Research Site
      • Sapporo, Japan, 003-0804
        • Werving
        • Research Site
      • Sapporo, Japan, 060-8638
        • Ingetrokken
        • Research Site
      • Shinjuku-ku, Japan, 160-8582
        • Werving
        • Research Site
      • Suita-shi, Japan, 565-0871
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        • Research Site
      • Sunto-gun, Japan, 411-8777
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        • Research Site
      • Toon-Shi, Japan, 791-0295
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        • Research Site
  • Mexico
      • Coyoacán, Mexico, 04380
        • Werving
        • Research Site
      • Culiacán, Mexico, 80040
        • Ingetrokken
        • Research Site
      • Guadalajara, Mexico, 44650
        • Werving
        • Research Site
      • Guadalajra, Mexico, 44260
        • Ingetrokken
        • Research Site
      • Mexico City, Mexico, 03240
        • Werving
        • Research Site
      • Monterrey, Mexico, 64460
        • Werving
        • Research Site
      • México, Mexico, 04700
        • Werving
        • Research Site
      • México, Mexico, 14080
        • Ingetrokken
        • Research Site
  • Noorwegen
      • Oslo, Noorwegen, 424
        • Werving
        • Research Site
      • Trondheim, Noorwegen, 7030
        • Werving
        • Research Site
  • Peru
      • Concepción, Peru, 12125
        • Beëindigd
        • Research Site
      • Lima, Peru, LIMA 29
        • Werving
        • Research Site
      • Lima, Peru, Lima 34
        • Werving
        • Research Site
      • Lima, Peru, 15036
        • Werving
        • Research Site
      • Lima, Peru, 15038
        • Werving
        • Research Site
      • Lima, Peru, 15102
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        • Research Site
      • Lima, Peru, Lima39
        • Werving
        • Research Site
  • Polen
      • Bialystok, Polen, 15-027
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        • Research Site
      • Gdansk, Polen, 80-214
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        • Research Site
      • Gliwice, Polen, 44-101
        • Werving
        • Research Site
      • Krakow, Polen, 30-348
        • Ingetrokken
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      • Lodz, Polen, 90-513
        • Ingetrokken
        • Research Site
      • Poznan, Polen, 61-866
        • Werving
        • Research Site
      • Warsaw, Polen, 02-781
        • Ingetrokken
        • Research Site
      • Wroclaw, Polen, 53-413
        • Werving
        • Research Site
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Ingetrokken
        • Research Site
  • Spanje
      • A Coruña, Spanje, 15009
        • Werving
        • Research Site
      • Barcelona, Spanje, 08036
        • Werving
        • Research Site
      • Barcelona, Spanje, 8035
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        • Research Site
      • Córdoba, Spanje, 14004
        • Werving
        • Research Site
      • Girona, Spanje, 17007
        • Werving
        • Research Site
      • Hospitalet deLlobregat, Spanje, 08907
        • Werving
        • Research Site
      • Madrid, Spanje, 28034
        • Werving
        • Research Site
      • Madrid, Spanje, 28040
        • Werving
        • Research Site
      • Madrid, Spanje, 28041
        • Werving
        • Research Site
      • Madrid, Spanje, 28046
        • Ingetrokken
        • Research Site
      • Palma de Mallorca, Spanje, 07010
        • Ingetrokken
        • Research Site
      • Valencia, Spanje, 46010
        • Ingetrokken
        • Research Site
      • Valencia, Spanje, 46009
        • Werving
        • Research Site
  • Taiwan
      • Changhua, Taiwan, 50006
        • Werving
        • Research Site
      • Kaohsiung City, Taiwan, 833
        • Werving
        • Research Site
      • Kaohsiung City, Taiwan, 81362
        • Werving
        • Research Site
      • New Taipei City, Taiwan, 220
        • Werving
        • Research Site
      • Taichung, Taiwan, 40447
        • Werving
        • Research Site
      • Taichung, Taiwan, 40705
        • Werving
        • Research Site
      • Tainan, Taiwan, 704
        • Werving
        • Research Site
      • Taipei, Taiwan, 11217
        • Werving
        • Research Site
      • Taipei, Taiwan, 10449
        • Werving
        • Research Site
      • Taoyuan, Taiwan, 333
        • Werving
        • Research Site
  • Thailand
      • Bangkok, Thailand, 10400
        • Werving
        • Research Site
      • Bangkok, Thailand, 10330
        • Werving
        • Research Site
      • Bangkok, Thailand, 10700
        • Werving
        • Research Site
      • Muang, Thailand, 50200
        • Werving
        • Research Site
      • Udon Thani, Thailand, 41330
        • Werving
        • Research Site
  • Turkije (Türkiye)
      • Adana, Turkije (Türkiye), 01250
        • Werving
        • Research Site
      • Ankara, Turkije (Türkiye), 06490
        • Werving
        • Research Site
      • Ankara, Turkije (Türkiye), 06100
        • Ingetrokken
        • Research Site
      • Cordaleo, Turkije (Türkiye), 35575
        • Werving
        • Research Site
      • Istanbul, Turkije (Türkiye), 32098
        • Ingetrokken
        • Research Site
      • Istanbul, Turkije (Türkiye), 34214
        • Ingetrokken
        • Research Site
  • Verenigde Staten
    • Alabama
      • Birmingham, Alabama, Verenigde Staten, 35233
        • Ingetrokken
        • Research Site
    • Arizona
      • Phoenix, Arizona, Verenigde Staten, 85016
        • Ingetrokken
        • Research Site
      • Tucson, Arizona, Verenigde Staten, 85711
        • Ingetrokken
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, Verenigde Staten, 72205
        • Ingetrokken
        • Research Site
    • California
      • La Jolla, California, Verenigde Staten, 92093
        • Ingetrokken
        • Research Site
      • West Hollywood, California, Verenigde Staten, 90048
        • Ingetrokken
        • Research Site
    • Georgia
      • Atlanta, Georgia, Verenigde Staten, 30322
        • Ingetrokken
        • Research Site
      • Augusta, Georgia, Verenigde Staten, 30912
        • Ingetrokken
        • Research Site
      • Savannah, Georgia, Verenigde Staten, 31405
        • Beëindigd
        • Research Site
    • Illinois
      • Melrose Park, Illinois, Verenigde Staten, 60160
        • Ingetrokken
        • Research Site
    • Indiana
      • Indianapolis, Indiana, Verenigde Staten, 46202
        • Ingetrokken
        • Research Site
    • Louisiana
      • New Orleans, Louisiana, Verenigde Staten, 70112
        • Ingetrokken
        • Research Site
      • New Orleans, Louisiana, Verenigde Staten, 70121
        • Ingetrokken
        • Research Site
      • Shreveport, Louisiana, Verenigde Staten, 71103
        • Voltooid
        • Research Site
    • New York
      • New York, New York, Verenigde Staten, 10016
        • Ingetrokken
        • Research Site
      • Syracuse, New York, Verenigde Staten, 13210
        • Ingetrokken
        • Research Site
    • Ohio
      • Cleveland, Ohio, Verenigde Staten, 44195
        • Ingetrokken
        • Research Site
      • Columbus, Ohio, Verenigde Staten, 43210
        • Ingetrokken
        • Research Site
    • Oregon
      • Eugene, Oregon, Verenigde Staten, 97401
        • Ingetrokken
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    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19107
        • Ingetrokken
        • Research Site
    • Rhode Island
      • Providence, Rhode Island, Verenigde Staten, 02905
        • Ingetrokken
        • Research Site
    • Texas
      • Dallas, Texas, Verenigde Staten, 75390
        • Ingetrokken
        • Research Site
      • Fort Worth, Texas, Verenigde Staten, 76104
        • Beëindigd
        • Research Site
      • Houston, Texas, Verenigde Staten, 77030
        • Ingetrokken
        • Research Site
      • Tyler, Texas, Verenigde Staten, 75702
        • Ingetrokken
        • Research Site
    • Virginia
      • Charlottesville, Virginia, Verenigde Staten, 22908
        • Voltooid
        • Research Site
      • Fairfax, Virginia, Verenigde Staten, 22031
        • Ingetrokken
        • Research Site
      • Richmond, Virginia, Verenigde Staten, 23298
        • Ingetrokken
        • Research Site
  • Zuid -Korea
      • Daegu, Zuid -Korea, 42601
        • Werving
        • Research Site
      • Goyang-si, Zuid -Korea, 10408
        • Werving
        • Research Site
      • Gyeonggi-do, Zuid -Korea, 13605
        • Werving
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      • Seoul, Zuid -Korea, 03080
        • Werving
        • Research Site
      • Seoul, Zuid -Korea, 06351
        • Werving
        • Research Site
      • Seoul, Zuid -Korea, 5505
        • Werving
        • Research Site
      • Seoul, Zuid -Korea, 03722
        • Werving
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Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

15 jaar en ouder (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

Inclusion Criteria:

For inclusion in the study, patients should fulfill the following criteria:

  1. Female.
  2. Aged at least 15 years at the time of screening. Note: Participants < 18 years of age: physical changes should be aligned with Tanner Stage III.
  3. Body weight > 35 kg.
  4. Histologically documented FIGO 2018 Stage IIIA to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with no evidence of metastatic disease.
  5. Initial staging procedures performed no more than 56 days prior to the first dose of CCRT.
  6. Provision of FFPE tumor sample to assess the PD-L1 expression.
  7. Must not have progressed following CCRT, participants with persistent disease after definitive CCRT must not be amenable to other available therapies with curative intent.
  8. WHO/ECOG performance status of 0 or 1; duration of life expectancy of ≥ 12 weeks.
  9. Adequate organ and bone marrow function.
  10. Capable of providing signed informed consent.

Exclusion Criteria:

Patients should not enter the study if any of the following exclusion criteria are fulfilled:

  1. Diagnosis of small cell (neuroendocrine) or mucinous adenocarcinoma of cervical cancer.
  2. Evidence of metastatic disease.
  3. Intent to administer a fertility-sparing treatment regimen.
  4. History of organ transplant or allogenic stem cell transplant.
  5. History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders.
  6. Uncontrolled intercurrent illness.
  7. History of another primary malignancy except for a) Malignancy treated with curative intent with no known active disease ≥2 years before the first dose of study intervention; b) Adequately treated nonmelanoma skin cancer or lentigo maligna, or carcinoma in situ without evidence of disease.
  8. Unresolved toxicities from previous CCRT except for irreversible toxicity that is not reasonably expected to be exacerbated.
  9. Prior history or presence of vesicovaginal, colovaginal, or rectovaginal fistula.
  10. History of anaphylaxis to any biologic therapy or vaccine.
  11. Current or prior use of immunosuppressive medication within 14 days before the first dose of the study intervention is excluded. The following are exceptions to this criterion: a) Intranasal, inhaled, topical steroids, or local steroid injections (eg, intraarticular injection); b) Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication or chemotherapy premedication) or a single dose for palliative purpose (eg, pain control); c) Physiologic doses of oral corticosteroids, ie, not exceeding 10 mg/day of prednisone (or equivalent) in the preceding 14 days.
  12. Patients who have undergone a previous hysterectomy, including a supracervical hysterectomy, or will have a hysterectomy as part of their initial cervical cancer therapy.
  13. Any prior (besides prior CCRT) or concurrent treatment for cervical cancer.
  14. Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery.
  15. Exposure to immune mediated therapy prior to the study for any indication.
  16. Receipt of live attenuated vaccine within 30 days prior to the first dose of the study intervention.
  17. Participants with a known allergy or hypersensitivity to the study intervention, or any excipients of the study intervention.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Placebo

Placebo
Ander: Placebo

IV Infusion

Andere namen:
  • Zoutoplossing
Experimenteel: Volrustomig

Volrustomig
Biologisch: Volrustomig

IV Infusion

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression-free Survival (PFS) based on the investigator assessment in all randomized participants (FAS)
Tijdsspanne: Up to approximately 7 years

PFS is defined as the time from date of randomization until RECIST 1.1- defined radiological progression or histopathologically confirmed progression as assessed by the Investigator or death due to any cause, whichever occurs earlier.
Up to approximately 7 years

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Survival (OS) in all randomized participants
Tijdsspanne: Up to approximately 7 years

OS defined as time from randomization until the date of death due to any cause.
Up to approximately 7 years
Objective Response Rate (ORR) in all randomized participants
Tijdsspanne: Up to approximately 7 years

ORR is defined as the proportion of participants who have a CR or PR, as determined by Investigator per RECIST 1.1
Up to approximately 7 years
Duration of Response (DoR) in all randomized participants
Tijdsspanne: Up to approximately 7 years

DoR in participants with a CR or PR: Time from date of first detection of CR or PR until the date of RECIST 1.1-defined radiological progression or histopathologically confirmed progression.
Up to approximately 7 years
Time to First Subsequent Therapy or death (TFST) in all randomized participants
Tijdsspanne: Up to approximately 7 years

TFST: The time from randomization until the start date of the first subsequent anti-cancer therapy after discontinuation of randomized treatment, or death due to any cause.
Up to approximately 7 years
Time to second progression or death (PFS2) in all randomized participants
Tijdsspanne: Up to approximately 7 years

PFS2: The time from randomization to the earliest of the progression event (following the initial Investigator-assessed progression), after first subsequent therapy, or death. The date of second progression will be recorded by the Investigator in the eCRF and defined according to local standard clinical practice.
Up to approximately 7 years
PFS by BICR in all randomized participants
Tijdsspanne: Up to approximately 7 years

Endpoints based on the PFS by BICR assessment according to RECIST 1.1.
Up to approximately 7 years
The incidence of local progression, and distant disease progression as the first documented progression event in all randomized participants
Tijdsspanne: Up to approximately 7 years

Incidence of Local Progression, and Distant Disease Progression: Number and percentage of participants who develop local progression, distant disease recurrence.
Up to approximately 7 years
PK of volrustomig
Tijdsspanne: Up to approximately 7 years

Concentration of volrustomig in serum and PK parameters as data allow.
Up to approximately 7 years
The immunogenicity of volrustomig
Tijdsspanne: Up to approximately 7 years

Incidence of ADAs against volrustomig in serum.
Up to approximately 7 years
Incidence of adverse events of volrustomig compared to placebo
Tijdsspanne: Up to approximately 7 years

An AE is defined as the development of any untoward medical occurrence (other than progression of the malignancy under evaluation) in a patient or clinical study participant administered a medicinal product, and which does not necessarily have a causal relationship with this treatment.
Up to approximately 7 years
Participant-reported disease-related symptoms
Tijdsspanne: Up to approximately 7 years

Change from baseline as measured by the European Organization for Research and Treatment of Cancer IL318 (EORTC IL318, Symptom Experience subscale of the EORTC Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24)). The score of scale for EORTC IL318 is from 1-4.
Up to approximately 7 years
Participant-reported physical functioning
Tijdsspanne: Up to approximately 7 years

Change from baseline of physical functioning as measured by the Patient Reported Outcomes Measurement Information System - Short Form - Physical Functioning 8c (PROMIS SF-PF 8c). The score of scale for PROMIS SF-PF 8c is from 1-5.
Up to approximately 7 years
Participant-reported global health status/Quality of Life
Tijdsspanne: Up to approximately 7 years

Change from baseline of Global Health Status/ Quality of Life (GHS/QoL) as measured by the European Organization for Research and Treatment of Cancer IL172 (EORTC IL172). The score of scale for EORTC IL172 is from 1-7.
Up to approximately 7 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

AstraZeneca

Medewerkers

European Network of Gynaecological Oncological Trial Groups (ENGOT)
Gynecologic Oncology Group Foundation

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

22 september 2023

Primaire voltooiing (Geschat)

26 november 2027

Studie voltooiing (Geschat)

30 september 2030

Studieregistratiedata

Eerst ingediend

4 september 2023

Eerst ingediend dat voldeed aan de QC-criteria

6 oktober 2023

Eerst geplaatst (Werkelijk)

12 oktober 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 september 2026

Laatste update ingediend die voldeed aan QC-criteria

29 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • D7984C00002
  • GOG-3092 (Andere identificatie: Gynecologic Oncology Group Foundation)
  • ENGOT-cx19/GEICO (Andere identificatie: European Network for Gynaecological Oncological Trial groups)
  • 165663 (Register-ID: FDA-IND)
  • 2023-504374-38-00 (Andere identificatie: EU CT)
  • 2023 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD-tijdsbestek voor delen

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD-toegangscriteria voor delen

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren