Undersøgelse af Volrustomig hos kvinder med højrisiko lokalt avanceret livmoderhalskræft (eVOLVE-Cervical) (eVOLVECervical)
9. november 2026 opdateret af: AstraZeneca
En fase III, randomiseret, dobbeltblind, placebokontrolleret, multicenter, global undersøgelse af volrustomig hos kvinder med højrisiko lokalt avanceret livmoderhalskræft, som ikke har udviklet sig efter platinbaseret, samtidig kemoradiationsterapi (eVOLVE-cervikal)
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.
Studieoversigt
Status
Status
Rekruttering
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
Women with locally advanced cervical cancer will be randomized in a 1:1 ratio to receive treatment with Volrustomig or Placebo.
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
Tilmelding
800
Fase
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
Studiekontakt
- Navn: AstraZeneca Clinical Study Information Center
- Telefonnummer: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
Studiesteder
-
-
-
Barretos, Brasilien, 14784-400
- Rekruttering
- Research Site
-
Belo Horizonte, Brasilien, 30130-100
- Rekruttering
- Research Site
-
Curitiba, Brasilien, 80730-150
- Rekruttering
- Research Site
-
Fortaleza, Brasilien, 60430-230
- Rekruttering
- Research Site
-
Fortaleza, Brasilien, 60336-045
- Rekruttering
- Research Site
-
Goiânia, Brasilien, 74110-060
- Ikke rekrutterer endnu
- Research Site
-
Ijuí, Brasilien, 98700-000
- Rekruttering
- Research Site
-
Natal, Brasilien, 59075-740
- Rekruttering
- Research Site
-
Porto Alegre, Brasilien, 90619-900
- Rekruttering
- Research Site
-
Porto Alegre, Brasilien, 98850-170
- Rekruttering
- Research Site
-
Porto Alegre, Brasilien, 90570-060
- Rekruttering
- Research Site
-
Porto Velho, Brasilien, 76834-899
- Rekruttering
- Research Site
-
Recife, Brasilien, 52010-075
- Rekruttering
- Research Site
-
Rio de Janeiro, Brasilien, 20220-410
- Rekruttering
- Research Site
-
Salvador, Brasilien, 40050 410
- Rekruttering
- Research Site
-
São Paulo, Brasilien, 01246-000
- Rekruttering
- Research Site
-
São Paulo, Brasilien, 1323001
- Rekruttering
- Research Site
-
São Paulo, Brasilien, 01323-000
- Ikke rekrutterer endnu
- Research Site
-
Teresina, Brasilien, 64049-200
- Rekruttering
- Research Site
-
-
-
-
Ontario
-
Hamilton, Ontario, Canada, L8V 1C3
- Rekruttering
- Research Site
-
London, Ontario, Canada, N6A 5W9
- Trukket tilbage
- Research Site
-
Toronto, Ontario, Canada, M4N 3M5
- Rekruttering
- Research Site
-
Toronto, Ontario, Canada, M5G 2M9
- Rekruttering
- Research Site
-
-
Quebec
-
Montreal, Quebec, Canada, H3G 1A4
- Rekruttering
- Research Site
-
Montreal, Quebec, Canada, H2X 0C1
- Rekruttering
- Research Site
-
Ste-Foy, Quebec, Canada, G1V 4G2
- Trukket tilbage
- Research Site
-
-
-
-
-
Aarhus N, Danmark, 8200
- Rekruttering
- Research Site
-
København Ø, Danmark, 2100
- Rekruttering
- Research Site
-
Odense, Danmark, 5000
- Rekruttering
- Research Site
-
-
-
-
Alabama
-
Birmingham, Alabama, Forenede Stater, 35233
- Trukket tilbage
- Research Site
-
-
Arizona
-
Phoenix, Arizona, Forenede Stater, 85016
- Trukket tilbage
- Research Site
-
Tucson, Arizona, Forenede Stater, 85711
- Trukket tilbage
- Research Site
-
-
Arkansas
-
Little Rock, Arkansas, Forenede Stater, 72205
- Trukket tilbage
- Research Site
-
-
California
-
La Jolla, California, Forenede Stater, 92093
- Trukket tilbage
- Research Site
-
West Hollywood, California, Forenede Stater, 90048
- Trukket tilbage
- Research Site
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater, 30322
- Trukket tilbage
- Research Site
-
Augusta, Georgia, Forenede Stater, 30912
- Trukket tilbage
- Research Site
-
Savannah, Georgia, Forenede Stater, 31405
- Afsluttet
- Research Site
-
-
Illinois
-
Melrose Park, Illinois, Forenede Stater, 60160
- Trukket tilbage
- Research Site
-
-
Indiana
-
Indianapolis, Indiana, Forenede Stater, 46202
- Trukket tilbage
- Research Site
-
-
Louisiana
-
New Orleans, Louisiana, Forenede Stater, 70112
- Trukket tilbage
- Research Site
-
New Orleans, Louisiana, Forenede Stater, 70121
- Trukket tilbage
- Research Site
-
Shreveport, Louisiana, Forenede Stater, 71103
- Afsluttet
- Research Site
-
-
New York
-
New York, New York, Forenede Stater, 10016
- Trukket tilbage
- Research Site
-
Syracuse, New York, Forenede Stater, 13210
- Trukket tilbage
- Research Site
-
-
Ohio
-
Cleveland, Ohio, Forenede Stater, 44195
- Trukket tilbage
- Research Site
-
Columbus, Ohio, Forenede Stater, 43210
- Trukket tilbage
- Research Site
-
-
Oregon
-
Eugene, Oregon, Forenede Stater, 97401
- Trukket tilbage
- Research Site
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater, 19107
- Trukket tilbage
- Research Site
-
-
Rhode Island
-
Providence, Rhode Island, Forenede Stater, 02905
- Trukket tilbage
- Research Site
-
-
Texas
-
Dallas, Texas, Forenede Stater, 75390
- Trukket tilbage
- Research Site
-
Fort Worth, Texas, Forenede Stater, 76104
- Afsluttet
- Research Site
-
Houston, Texas, Forenede Stater, 77030
- Trukket tilbage
- Research Site
-
Tyler, Texas, Forenede Stater, 75702
- Trukket tilbage
- Research Site
-
-
Virginia
-
Charlottesville, Virginia, Forenede Stater, 22908
- Afsluttet
- Research Site
-
Fairfax, Virginia, Forenede Stater, 22031
- Trukket tilbage
- Research Site
-
Richmond, Virginia, Forenede Stater, 23298
- Trukket tilbage
- Research Site
-
-
-
-
-
Calicut, Indien, 673601
- Afsluttet
- Research Site
-
Jaipur, Indien, 302017
- Rekruttering
- Research Site
-
Lucknow, Indien, 226003
- Trukket tilbage
- Research Site
-
Madurai, Indien, 625107
- Rekruttering
- Research Site
-
Mohali, Indien, 160055
- Trukket tilbage
- Research Site
-
Nagpur, Indien, 440001
- Rekruttering
- Research Site
-
Nashik, Indien, 422009
- Rekruttering
- Research Site
-
Nashik, Indien, 422011
- Rekruttering
- Research Site
-
New Delhi, Indien, 110029
- Rekruttering
- Research Site
-
Vadodara, Indien, 391760
- Rekruttering
- Research Site
-
-
-
-
-
Bari, Italien, 70124
- Trukket tilbage
- Research Site
-
Bologna, Italien, 40138
- Rekruttering
- Research Site
-
Catania, Italien, 95126
- Rekruttering
- Research Site
-
Florence, Italien, 50141
- Rekruttering
- Research Site
-
Lecco, Italien, 23900
- Afsluttet
- Research Site
-
Milan, Italien, 20141
- Rekruttering
- Research Site
-
Milan, Italien, 20159
- Rekruttering
- Research Site
-
Milan, Italien, 20133
- Rekruttering
- Research Site
-
Monza, Italien, 20900
- Rekruttering
- Research Site
-
Naples, Italien, 80131
- Rekruttering
- Research Site
-
Roma, Italien, 161
- Rekruttering
- Research Site
-
Rome, Italien, 00168
- Rekruttering
- Research Site
-
Turin, Italien, 10128
- Rekruttering
- Research Site
-
-
-
-
-
Fukuoka, Japan, 812-8582
- Rekruttering
- Research Site
-
Ginowan-shi, Japan, 901-2725
- Rekruttering
- Research Site
-
Hidaka-shi, Japan, 350-1298
- Rekruttering
- Research Site
-
Kagoshima, Japan, 890-8520
- Rekruttering
- Research Site
-
Kurume-shi, Japan, 830-0011
- Rekruttering
- Research Site
-
Kōtoku, Japan, 135-8550
- Rekruttering
- Research Site
-
Maebashi, Japan, 371-8511
- Rekruttering
- Research Site
-
Matsuyama, Japan, 791-0280
- Rekruttering
- Research Site
-
Morioka, Japan, 028-3695
- Rekruttering
- Research Site
-
Nagoya, Japan, 464-8681
- Rekruttering
- Research Site
-
Osaka, Japan, 541-8567
- Trukket tilbage
- Research Site
-
Sapporo, Japan, 003-0804
- Rekruttering
- Research Site
-
Sapporo, Japan, 060-8638
- Trukket tilbage
- Research Site
-
Shinjuku-ku, Japan, 160-8582
- Rekruttering
- Research Site
-
Suita-shi, Japan, 565-0871
- Rekruttering
- Research Site
-
Sunto-gun, Japan, 411-8777
- Rekruttering
- Research Site
-
Toon-Shi, Japan, 791-0295
- Rekruttering
- Research Site
-
-
-
-
-
Beijing, Kina, 100730
- Rekruttering
- Research Site
-
Beijing, Kina, 100142
- Rekruttering
- Research Site
-
Beijing, Kina, 100026
- Rekruttering
- Research Site
-
Changde, Kina, 415000
- Rekruttering
- Research Site
-
Changsha, Kina, 410008
- Rekruttering
- Research Site
-
Changsha, Kina, 410013
- Rekruttering
- Research Site
-
Chengdu, Kina, 610041
- Rekruttering
- Research Site
-
Chengdu, Kina, 610044
- Rekruttering
- Research Site
-
Chongqing, Kina, 400030
- Rekruttering
- Research Site
-
Fuzhou, Kina, 350014
- Rekruttering
- Research Site
-
Ganzhou, Kina, 341000
- Rekruttering
- Research Site
-
Guangzhou, Kina, 510060
- Rekruttering
- Research Site
-
Guangzhou, Kina, 510120
- Trukket tilbage
- Research Site
-
Hangzhou, Kina, 310022
- Rekruttering
- Research Site
-
Harbin, Kina, 150081
- Rekruttering
- Research Site
-
Kunming, Kina, 650118
- Rekruttering
- Research Site
-
Lanzhou, Kina, 730050
- Rekruttering
- Research Site
-
Lanzhou, Kina, 730000
- Afsluttet
- Research Site
-
Linyi, Kina, 276001
- Rekruttering
- Research Site
-
Luzhou, Kina, 646000
- Trukket tilbage
- Research Site
-
Nanchang, Kina, 330006
- Rekruttering
- Research Site
-
Nanchang, Kina, 330029
- Rekruttering
- Research Site
-
Shandong, Kina
- Trukket tilbage
- Research Site
-
Shanghai, Kina, 200032
- Rekruttering
- Research Site
-
Shanghai, Kina, 200080
- Rekruttering
- Research Site
-
Shenyang, Kina, 110004
- Rekruttering
- Research Site
-
Shenzhen, Kina, 518036
- Rekruttering
- Research Site
-
Shenzhen, Kina, 518116
- Rekruttering
- Research Site
-
Tianjin, Kina, 300060
- Rekruttering
- Research Site
-
Wuhan, Kina, 430022
- Rekruttering
- Research Site
-
Wuhan, Kina, 430030
- Rekruttering
- Research Site
-
Xi'an, Kina, 710061
- Rekruttering
- Research Site
-
Yibin, Kina, 610500
- Trukket tilbage
- Research Site
-
Yinchuan, Kina, 750004
- Rekruttering
- Research Site
-
Zhengzhou, Kina, 450008
- Rekruttering
- Research Site
-
Zhengzhou, Kina, 450052
- Afsluttet
- Research Site
-
Zhuzhou, Kina, 412007
- Rekruttering
- Research Site
-
-
-
-
-
Coyoacán, Mexico, 04380
- Rekruttering
- Research Site
-
Culiacán, Mexico, 80040
- Trukket tilbage
- Research Site
-
Guadalajara, Mexico, 44650
- Rekruttering
- Research Site
-
Guadalajra, Mexico, 44260
- Trukket tilbage
- Research Site
-
Mexico City, Mexico, 03240
- Rekruttering
- Research Site
-
Monterrey, Mexico, 64460
- Rekruttering
- Research Site
-
México, Mexico, 04700
- Rekruttering
- Research Site
-
México, Mexico, 14080
- Trukket tilbage
- Research Site
-
-
-
-
-
Oslo, Norge, 424
- Rekruttering
- Research Site
-
Trondheim, Norge, 7030
- Rekruttering
- Research Site
-
-
-
-
-
Concepción, Peru, 12125
- Afsluttet
- Research Site
-
Lima, Peru, LIMA 29
- Rekruttering
- Research Site
-
Lima, Peru, Lima 34
- Rekruttering
- Research Site
-
Lima, Peru, 15036
- Rekruttering
- Research Site
-
Lima, Peru, 15038
- Rekruttering
- Research Site
-
Lima, Peru, 15102
- Rekruttering
- Research Site
-
Lima, Peru, Lima39
- Rekruttering
- Research Site
-
-
-
-
-
Bialystok, Polen, 15-027
- Rekruttering
- Research Site
-
Gdansk, Polen, 80-214
- Rekruttering
- Research Site
-
Gliwice, Polen, 44-101
- Rekruttering
- Research Site
-
Krakow, Polen, 30-348
- Trukket tilbage
- Research Site
-
Lodz, Polen, 90-513
- Trukket tilbage
- Research Site
-
Poznan, Polen, 61-866
- Rekruttering
- Research Site
-
Warsaw, Polen, 02-781
- Trukket tilbage
- Research Site
-
Wroclaw, Polen, 53-413
- Trukket tilbage
- Research Site
-
-
-
-
-
San Juan, Puerto Rico, 00927
- Trukket tilbage
- Research Site
-
-
-
-
-
A Coruña, Spanien, 15009
- Rekruttering
- Research Site
-
Barcelona, Spanien, 08036
- Rekruttering
- Research Site
-
Barcelona, Spanien, 8035
- Rekruttering
- Research Site
-
Córdoba, Spanien, 14004
- Rekruttering
- Research Site
-
Girona, Spanien, 17007
- Rekruttering
- Research Site
-
Hospitalet deLlobregat, Spanien, 08907
- Rekruttering
- Research Site
-
Madrid, Spanien, 28034
- Rekruttering
- Research Site
-
Madrid, Spanien, 28040
- Rekruttering
- Research Site
-
Madrid, Spanien, 28041
- Rekruttering
- Research Site
-
Madrid, Spanien, 28046
- Trukket tilbage
- Research Site
-
Palma de Mallorca, Spanien, 07010
- Trukket tilbage
- Research Site
-
Valencia, Spanien, 46010
- Trukket tilbage
- Research Site
-
Valencia, Spanien, 46009
- Rekruttering
- Research Site
-
-
-
-
-
Daegu, Sydkorea, 42601
- Rekruttering
- Research Site
-
Goyang-si, Sydkorea, 10408
- Rekruttering
- Research Site
-
Gyeonggi-do, Sydkorea, 13605
- Rekruttering
- Research Site
-
Seoul, Sydkorea, 03080
- Rekruttering
- Research Site
-
Seoul, Sydkorea, 06351
- Rekruttering
- Research Site
-
Seoul, Sydkorea, 5505
- Rekruttering
- Research Site
-
Seoul, Sydkorea, 03722
- Rekruttering
- Research Site
-
-
-
-
-
Changhua, Taiwan, 50006
- Rekruttering
- Research Site
-
Kaohsiung City, Taiwan, 833
- Rekruttering
- Research Site
-
Kaohsiung City, Taiwan, 81362
- Rekruttering
- Research Site
-
New Taipei City, Taiwan, 220
- Rekruttering
- Research Site
-
Taichung, Taiwan, 40447
- Rekruttering
- Research Site
-
Taichung, Taiwan, 40705
- Rekruttering
- Research Site
-
Tainan, Taiwan, 704
- Rekruttering
- Research Site
-
Taipei, Taiwan, 11217
- Rekruttering
- Research Site
-
Taipei, Taiwan, 10449
- Rekruttering
- Research Site
-
Taoyuan, Taiwan, 333
- Rekruttering
- Research Site
-
-
-
-
-
Bangkok, Thailand, 10400
- Rekruttering
- Research Site
-
Bangkok, Thailand, 10330
- Rekruttering
- Research Site
-
Bangkok, Thailand, 10700
- Rekruttering
- Research Site
-
Muang, Thailand, 50200
- Rekruttering
- Research Site
-
Udon Thani, Thailand, 41330
- Rekruttering
- Research Site
-
-
-
-
-
Adana, Tyrkiet (Türkiye), 01250
- Rekruttering
- Research Site
-
Ankara, Tyrkiet (Türkiye), 06490
- Rekruttering
- Research Site
-
Ankara, Tyrkiet (Türkiye), 06100
- Trukket tilbage
- Research Site
-
Cordaleo, Tyrkiet (Türkiye), 35575
- Rekruttering
- Research Site
-
Istanbul, Tyrkiet (Türkiye), 32098
- Trukket tilbage
- Research Site
-
Istanbul, Tyrkiet (Türkiye), 34214
- Trukket tilbage
- Research Site
-
-
-
-
-
Berlin, Tyskland, 13353
- Rekruttering
- Research Site
-
Bonn, Tyskland, 53127
- Rekruttering
- Research Site
-
Hamburg, Tyskland, 20246
- Rekruttering
- Research Site
-
Leipzig, Tyskland, 04103
- Rekruttering
- Research Site
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
15 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
For inclusion in the study, patients should fulfill the following criteria:
- Female.
- 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.
- Body weight > 35 kg.
- Histologically documented FIGO 2018 Stage IIIA to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with no evidence of metastatic disease.
- Initial staging procedures performed no more than 56 days prior to the first dose of CCRT.
- Provision of FFPE tumor sample to assess the PD-L1 expression.
- Must not have progressed following CCRT, participants with persistent disease after definitive CCRT must not be amenable to other available therapies with curative intent.
- WHO/ECOG performance status of 0 or 1; duration of life expectancy of ≥ 12 weeks.
- Adequate organ and bone marrow function.
- Capable of providing signed informed consent.
Exclusion Criteria:
Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- Diagnosis of small cell (neuroendocrine) or mucinous adenocarcinoma of cervical cancer.
- Evidence of metastatic disease.
- Intent to administer a fertility-sparing treatment regimen.
- History of organ transplant or allogenic stem cell transplant.
- History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders.
- Uncontrolled intercurrent illness.
- 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.
- Unresolved toxicities from previous CCRT except for irreversible toxicity that is not reasonably expected to be exacerbated.
- Prior history or presence of vesicovaginal, colovaginal, or rectovaginal fistula.
- History of anaphylaxis to any biologic therapy or vaccine.
- 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.
- Patients who have undergone a previous hysterectomy, including a supracervical hysterectomy, or will have a hysterectomy as part of their initial cervical cancer therapy.
- Any prior (besides prior CCRT) or concurrent treatment for cervical cancer.
- Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery.
- Exposure to immune mediated therapy prior to the study for any indication.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of the study intervention.
- Participants with a known allergy or hypersensitivity to the study intervention, or any excipients of the study intervention.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Antal våben
2
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
Placebo |
IV Infusion
Andre navne:
|
|
Eksperimentel: Volrustomig
Volrustomig |
IV Infusion |
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-free Survival (PFS) based on the investigator assessment in all randomized participants (FAS)
Tidsramme: 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
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival (OS) in all randomized participants
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
22. september 2023
Primær færdiggørelse (Anslået)
Primær færdiggørelse
26. november 2027
Studieafslutning (Anslået)
Studieafslutning
30. september 2030
Datoer for studieregistrering
Først indsendt
Først indsendt
4. september 2023
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
6. oktober 2023
Først opslået (Faktiske)
Først opslået
12. oktober 2023
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
10. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. november 2026
Sidst verificeret
Sidst verificeret
1. november 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- D7984C00002
- GOG-3092 (Anden identifikator: Gynecologic Oncology Group Foundation)
- ENGOT-cx19/GEICO (Anden identifikator: European Network for Gynaecological Oncological Trial groups)
- 165663 (Registry Identifier: FDA-IND)
- 2023-504374-38-00 (Anden identifikator: EU CT)
- 2023 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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-delingstidsramme
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-delingsadgangskriterier
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-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ja
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .