Studie av Volrustomig hos kvinnor med hög risk lokalt avancerad livmoderhalscancer (eVOLVE-Cervical) (eVOLVECervical)
9 november 2026 uppdaterad av: AstraZeneca
En fas III, randomiserad, dubbelblind, placebokontrollerad, multicenter, global studie av volrustomig hos kvinnor med högrisk lokalt avancerad livmoderhalscancer som inte har utvecklats efter platinabaserad, 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Women with locally advanced cervical cancer will be randomized in a 1:1 ratio to receive treatment with Volrustomig or Placebo.
Studietyp
Interventionell
Inskrivning (Beräknad)
800
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: AstraZeneca Clinical Study Information Center
- Telefonnummer: 1-877-240-9479
- E-post: information.center@astrazeneca.com
Studieorter
-
-
-
Barretos, Brasilien, 14784-400
- Rekrytering
- Research Site
-
Belo Horizonte, Brasilien, 30130-100
- Rekrytering
- Research Site
-
Curitiba, Brasilien, 80730-150
- Rekrytering
- Research Site
-
Fortaleza, Brasilien, 60430-230
- Rekrytering
- Research Site
-
Fortaleza, Brasilien, 60336-045
- Rekrytering
- Research Site
-
Goiânia, Brasilien, 74110-060
- Har inte rekryterat ännu
- Research Site
-
Ijuí, Brasilien, 98700-000
- Rekrytering
- Research Site
-
Natal, Brasilien, 59075-740
- Rekrytering
- Research Site
-
Porto Alegre, Brasilien, 90619-900
- Rekrytering
- Research Site
-
Porto Alegre, Brasilien, 98850-170
- Rekrytering
- Research Site
-
Porto Alegre, Brasilien, 90570-060
- Rekrytering
- Research Site
-
Porto Velho, Brasilien, 76834-899
- Rekrytering
- Research Site
-
Recife, Brasilien, 52010-075
- Rekrytering
- Research Site
-
Rio de Janeiro, Brasilien, 20220-410
- Rekrytering
- Research Site
-
Salvador, Brasilien, 40050 410
- Rekrytering
- Research Site
-
São Paulo, Brasilien, 01246-000
- Rekrytering
- Research Site
-
São Paulo, Brasilien, 1323001
- Rekrytering
- Research Site
-
São Paulo, Brasilien, 01323-000
- Har inte rekryterat ännu
- Research Site
-
Teresina, Brasilien, 64049-200
- Rekrytering
- Research Site
-
-
-
-
-
Aarhus N, Danmark, 8200
- Rekrytering
- Research Site
-
København Ø, Danmark, 2100
- Rekrytering
- Research Site
-
Odense, Danmark, 5000
- Rekrytering
- Research Site
-
-
-
-
Alabama
-
Birmingham, Alabama, Förenta staterna, 35233
- Indragen
- Research Site
-
-
Arizona
-
Phoenix, Arizona, Förenta staterna, 85016
- Indragen
- Research Site
-
Tucson, Arizona, Förenta staterna, 85711
- Indragen
- Research Site
-
-
Arkansas
-
Little Rock, Arkansas, Förenta staterna, 72205
- Indragen
- Research Site
-
-
California
-
La Jolla, California, Förenta staterna, 92093
- Indragen
- Research Site
-
West Hollywood, California, Förenta staterna, 90048
- Indragen
- Research Site
-
-
Georgia
-
Atlanta, Georgia, Förenta staterna, 30322
- Indragen
- Research Site
-
Augusta, Georgia, Förenta staterna, 30912
- Indragen
- Research Site
-
Savannah, Georgia, Förenta staterna, 31405
- Avslutad
- Research Site
-
-
Illinois
-
Melrose Park, Illinois, Förenta staterna, 60160
- Indragen
- Research Site
-
-
Indiana
-
Indianapolis, Indiana, Förenta staterna, 46202
- Indragen
- Research Site
-
-
Louisiana
-
New Orleans, Louisiana, Förenta staterna, 70112
- Indragen
- Research Site
-
New Orleans, Louisiana, Förenta staterna, 70121
- Indragen
- Research Site
-
Shreveport, Louisiana, Förenta staterna, 71103
- Avslutad
- Research Site
-
-
New York
-
New York, New York, Förenta staterna, 10016
- Indragen
- Research Site
-
Syracuse, New York, Förenta staterna, 13210
- Indragen
- Research Site
-
-
Ohio
-
Cleveland, Ohio, Förenta staterna, 44195
- Indragen
- Research Site
-
Columbus, Ohio, Förenta staterna, 43210
- Indragen
- Research Site
-
-
Oregon
-
Eugene, Oregon, Förenta staterna, 97401
- Indragen
- Research Site
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Förenta staterna, 19107
- Indragen
- Research Site
-
-
Rhode Island
-
Providence, Rhode Island, Förenta staterna, 02905
- Indragen
- Research Site
-
-
Texas
-
Dallas, Texas, Förenta staterna, 75390
- Indragen
- Research Site
-
Fort Worth, Texas, Förenta staterna, 76104
- Avslutad
- Research Site
-
Houston, Texas, Förenta staterna, 77030
- Indragen
- Research Site
-
Tyler, Texas, Förenta staterna, 75702
- Indragen
- Research Site
-
-
Virginia
-
Charlottesville, Virginia, Förenta staterna, 22908
- Avslutad
- Research Site
-
Fairfax, Virginia, Förenta staterna, 22031
- Indragen
- Research Site
-
Richmond, Virginia, Förenta staterna, 23298
- Indragen
- Research Site
-
-
-
-
-
Calicut, Indien, 673601
- Avslutad
- Research Site
-
Jaipur, Indien, 302017
- Rekrytering
- Research Site
-
Lucknow, Indien, 226003
- Indragen
- Research Site
-
Madurai, Indien, 625107
- Rekrytering
- Research Site
-
Mohali, Indien, 160055
- Indragen
- Research Site
-
Nagpur, Indien, 440001
- Rekrytering
- Research Site
-
Nashik, Indien, 422009
- Rekrytering
- Research Site
-
Nashik, Indien, 422011
- Rekrytering
- Research Site
-
New Delhi, Indien, 110029
- Rekrytering
- Research Site
-
Vadodara, Indien, 391760
- Rekrytering
- Research Site
-
-
-
-
-
Bari, Italien, 70124
- Indragen
- Research Site
-
Bologna, Italien, 40138
- Rekrytering
- Research Site
-
Catania, Italien, 95126
- Rekrytering
- Research Site
-
Florence, Italien, 50141
- Rekrytering
- Research Site
-
Lecco, Italien, 23900
- Avslutad
- Research Site
-
Milan, Italien, 20141
- Rekrytering
- Research Site
-
Milan, Italien, 20159
- Rekrytering
- Research Site
-
Milan, Italien, 20133
- Rekrytering
- Research Site
-
Monza, Italien, 20900
- Rekrytering
- Research Site
-
Naples, Italien, 80131
- Rekrytering
- Research Site
-
Roma, Italien, 161
- Rekrytering
- Research Site
-
Rome, Italien, 00168
- Rekrytering
- Research Site
-
Turin, Italien, 10128
- Rekrytering
- Research Site
-
-
-
-
-
Fukuoka, Japan, 812-8582
- Rekrytering
- Research Site
-
Ginowan-shi, Japan, 901-2725
- Rekrytering
- Research Site
-
Hidaka-shi, Japan, 350-1298
- Rekrytering
- Research Site
-
Kagoshima, Japan, 890-8520
- Rekrytering
- Research Site
-
Kurume-shi, Japan, 830-0011
- Rekrytering
- Research Site
-
Kōtoku, Japan, 135-8550
- Rekrytering
- Research Site
-
Maebashi, Japan, 371-8511
- Rekrytering
- Research Site
-
Matsuyama, Japan, 791-0280
- Rekrytering
- Research Site
-
Morioka, Japan, 028-3695
- Rekrytering
- Research Site
-
Nagoya, Japan, 464-8681
- Rekrytering
- Research Site
-
Osaka, Japan, 541-8567
- Indragen
- Research Site
-
Sapporo, Japan, 003-0804
- Rekrytering
- Research Site
-
Sapporo, Japan, 060-8638
- Indragen
- Research Site
-
Shinjuku-ku, Japan, 160-8582
- Rekrytering
- Research Site
-
Suita-shi, Japan, 565-0871
- Rekrytering
- Research Site
-
Sunto-gun, Japan, 411-8777
- Rekrytering
- Research Site
-
Toon-Shi, Japan, 791-0295
- Rekrytering
- Research Site
-
-
-
-
Ontario
-
Hamilton, Ontario, Kanada, L8V 1C3
- Rekrytering
- Research Site
-
London, Ontario, Kanada, N6A 5W9
- Indragen
- Research Site
-
Toronto, Ontario, Kanada, M4N 3M5
- Rekrytering
- Research Site
-
Toronto, Ontario, Kanada, M5G 2M9
- Rekrytering
- Research Site
-
-
Quebec
-
Montreal, Quebec, Kanada, H3G 1A4
- Rekrytering
- Research Site
-
Montreal, Quebec, Kanada, H2X 0C1
- Rekrytering
- Research Site
-
Ste-Foy, Quebec, Kanada, G1V 4G2
- Indragen
- Research Site
-
-
-
-
-
Beijing, Kina, 100730
- Rekrytering
- Research Site
-
Beijing, Kina, 100142
- Rekrytering
- Research Site
-
Beijing, Kina, 100026
- Rekrytering
- Research Site
-
Changde, Kina, 415000
- Rekrytering
- Research Site
-
Changsha, Kina, 410008
- Rekrytering
- Research Site
-
Changsha, Kina, 410013
- Rekrytering
- Research Site
-
Chengdu, Kina, 610041
- Rekrytering
- Research Site
-
Chengdu, Kina, 610044
- Rekrytering
- Research Site
-
Chongqing, Kina, 400030
- Rekrytering
- Research Site
-
Fuzhou, Kina, 350014
- Rekrytering
- Research Site
-
Ganzhou, Kina, 341000
- Rekrytering
- Research Site
-
Guangzhou, Kina, 510060
- Rekrytering
- Research Site
-
Guangzhou, Kina, 510120
- Indragen
- Research Site
-
Hangzhou, Kina, 310022
- Rekrytering
- Research Site
-
Harbin, Kina, 150081
- Rekrytering
- Research Site
-
Kunming, Kina, 650118
- Rekrytering
- Research Site
-
Lanzhou, Kina, 730050
- Rekrytering
- Research Site
-
Lanzhou, Kina, 730000
- Avslutad
- Research Site
-
Linyi, Kina, 276001
- Rekrytering
- Research Site
-
Luzhou, Kina, 646000
- Indragen
- Research Site
-
Nanchang, Kina, 330006
- Rekrytering
- Research Site
-
Nanchang, Kina, 330029
- Rekrytering
- Research Site
-
Shandong, Kina
- Indragen
- Research Site
-
Shanghai, Kina, 200032
- Rekrytering
- Research Site
-
Shanghai, Kina, 200080
- Rekrytering
- Research Site
-
Shenyang, Kina, 110004
- Rekrytering
- Research Site
-
Shenzhen, Kina, 518036
- Rekrytering
- Research Site
-
Shenzhen, Kina, 518116
- Rekrytering
- Research Site
-
Tianjin, Kina, 300060
- Rekrytering
- Research Site
-
Wuhan, Kina, 430022
- Rekrytering
- Research Site
-
Wuhan, Kina, 430030
- Rekrytering
- Research Site
-
Xi'an, Kina, 710061
- Rekrytering
- Research Site
-
Yibin, Kina, 610500
- Indragen
- Research Site
-
Yinchuan, Kina, 750004
- Rekrytering
- Research Site
-
Zhengzhou, Kina, 450008
- Rekrytering
- Research Site
-
Zhengzhou, Kina, 450052
- Avslutad
- Research Site
-
Zhuzhou, Kina, 412007
- Rekrytering
- Research Site
-
-
-
-
-
Coyoacán, Mexiko, 04380
- Rekrytering
- Research Site
-
Culiacán, Mexiko, 80040
- Indragen
- Research Site
-
Guadalajara, Mexiko, 44650
- Rekrytering
- Research Site
-
Guadalajra, Mexiko, 44260
- Indragen
- Research Site
-
Mexico City, Mexiko, 03240
- Rekrytering
- Research Site
-
Monterrey, Mexiko, 64460
- Rekrytering
- Research Site
-
México, Mexiko, 04700
- Rekrytering
- Research Site
-
México, Mexiko, 14080
- Indragen
- Research Site
-
-
-
-
-
Oslo, Norge, 424
- Rekrytering
- Research Site
-
Trondheim, Norge, 7030
- Rekrytering
- Research Site
-
-
-
-
-
Concepción, Peru, 12125
- Avslutad
- Research Site
-
Lima, Peru, LIMA 29
- Rekrytering
- Research Site
-
Lima, Peru, Lima 34
- Rekrytering
- Research Site
-
Lima, Peru, 15036
- Rekrytering
- Research Site
-
Lima, Peru, 15038
- Rekrytering
- Research Site
-
Lima, Peru, 15102
- Rekrytering
- Research Site
-
Lima, Peru, Lima39
- Rekrytering
- Research Site
-
-
-
-
-
Bialystok, Polen, 15-027
- Rekrytering
- Research Site
-
Gdansk, Polen, 80-214
- Rekrytering
- Research Site
-
Gliwice, Polen, 44-101
- Rekrytering
- Research Site
-
Krakow, Polen, 30-348
- Indragen
- Research Site
-
Lodz, Polen, 90-513
- Indragen
- Research Site
-
Poznan, Polen, 61-866
- Rekrytering
- Research Site
-
Warsaw, Polen, 02-781
- Indragen
- Research Site
-
Wroclaw, Polen, 53-413
- Indragen
- Research Site
-
-
-
-
-
San Juan, Puerto Rico, 00927
- Indragen
- Research Site
-
-
-
-
-
A Coruña, Spanien, 15009
- Rekrytering
- Research Site
-
Barcelona, Spanien, 08036
- Rekrytering
- Research Site
-
Barcelona, Spanien, 8035
- Rekrytering
- Research Site
-
Córdoba, Spanien, 14004
- Rekrytering
- Research Site
-
Girona, Spanien, 17007
- Rekrytering
- Research Site
-
Hospitalet deLlobregat, Spanien, 08907
- Rekrytering
- Research Site
-
Madrid, Spanien, 28034
- Rekrytering
- Research Site
-
Madrid, Spanien, 28040
- Rekrytering
- Research Site
-
Madrid, Spanien, 28041
- Rekrytering
- Research Site
-
Madrid, Spanien, 28046
- Indragen
- Research Site
-
Palma de Mallorca, Spanien, 07010
- Indragen
- Research Site
-
Valencia, Spanien, 46010
- Indragen
- Research Site
-
Valencia, Spanien, 46009
- Rekrytering
- Research Site
-
-
-
-
-
Daegu, Sydkorea, 42601
- Rekrytering
- Research Site
-
Goyang-si, Sydkorea, 10408
- Rekrytering
- Research Site
-
Gyeonggi-do, Sydkorea, 13605
- Rekrytering
- Research Site
-
Seoul, Sydkorea, 03080
- Rekrytering
- Research Site
-
Seoul, Sydkorea, 06351
- Rekrytering
- Research Site
-
Seoul, Sydkorea, 5505
- Rekrytering
- Research Site
-
Seoul, Sydkorea, 03722
- Rekrytering
- Research Site
-
-
-
-
-
Changhua, Taiwan, 50006
- Rekrytering
- Research Site
-
Kaohsiung City, Taiwan, 833
- Rekrytering
- Research Site
-
Kaohsiung City, Taiwan, 81362
- Rekrytering
- Research Site
-
New Taipei City, Taiwan, 220
- Rekrytering
- Research Site
-
Taichung, Taiwan, 40447
- Rekrytering
- Research Site
-
Taichung, Taiwan, 40705
- Rekrytering
- Research Site
-
Tainan, Taiwan, 704
- Rekrytering
- Research Site
-
Taipei, Taiwan, 11217
- Rekrytering
- Research Site
-
Taipei, Taiwan, 10449
- Rekrytering
- Research Site
-
Taoyuan, Taiwan, 333
- Rekrytering
- Research Site
-
-
-
-
-
Bangkok, Thailand, 10400
- Rekrytering
- Research Site
-
Bangkok, Thailand, 10330
- Rekrytering
- Research Site
-
Bangkok, Thailand, 10700
- Rekrytering
- Research Site
-
Muang, Thailand, 50200
- Rekrytering
- Research Site
-
Udon Thani, Thailand, 41330
- Rekrytering
- Research Site
-
-
-
-
-
Adana, Turkiet (Türkiye), 01250
- Rekrytering
- Research Site
-
Ankara, Turkiet (Türkiye), 06490
- Rekrytering
- Research Site
-
Ankara, Turkiet (Türkiye), 06100
- Indragen
- Research Site
-
Cordaleo, Turkiet (Türkiye), 35575
- Rekrytering
- Research Site
-
Istanbul, Turkiet (Türkiye), 32098
- Indragen
- Research Site
-
Istanbul, Turkiet (Türkiye), 34214
- Indragen
- Research Site
-
-
-
-
-
Berlin, Tyskland, 13353
- Rekrytering
- Research Site
-
Bonn, Tyskland, 53127
- Rekrytering
- Research Site
-
Hamburg, Tyskland, 20246
- Rekrytering
- Research Site
-
Leipzig, Tyskland, 04103
- Rekrytering
- Research Site
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
15 år och äldre (Barn, Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: Placebo
Placebo |
IV Infusion
Andra namn:
|
|
Experimentell: Volrustomig
Volrustomig |
IV Infusion |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Progression-free Survival (PFS) based on the investigator assessment in all randomized participants (FAS)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall Survival (OS) in all randomized participants
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
22 september 2023
Primärt slutförande (Beräknad)
26 november 2027
Avslutad studie (Beräknad)
30 september 2030
Studieregistreringsdatum
Först inskickad
4 september 2023
Först inskickad som uppfyllde QC-kriterierna
6 oktober 2023
Första postat (Faktisk)
12 oktober 2023
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
10 november 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 november 2026
Senast verifierad
1 november 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- D7984C00002
- GOG-3092 (Annan identifierare: Gynecologic Oncology Group Foundation)
- ENGOT-cx19/GEICO (Annan identifierare: European Network for Gynaecological Oncological Trial groups)
- 165663 (Registeridentifierare: FDA-IND)
- 2023-504374-38-00 (Annan identifierare: EU CT)
- 2023 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Tidsram för IPD-delning
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.
Kriterier för IPD Sharing Access
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-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .