Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical) (eVOLVECervical)

May 26, 2026 updated by: AstraZeneca

A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-centre, Global Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer Who Have Not Progressed Following Platinum-based, Concurrent Chemoradiation Therapy (eVOLVE-Cervical)

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.

Study Overview

Status

Recruiting

Conditions

Locally Advanced Cervical Cancer

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

800

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: AstraZeneca Clinical Study Information Center
Phone Number: 1-877-240-9479
Email: information.center@astrazeneca.com

Study Locations

Brazil
- - Barretos, Brazil, 14784-400
    - Recruiting
    - Research Site
  - Belo Horizonte, Brazil, 30130-100
    - Recruiting
    - Research Site
  - Curitiba, Brazil, 80730-150
    - Recruiting
    - Research Site
  - Fortaleza, Brazil, 60430-230
    - Not yet recruiting
    - Research Site
  - Fortaleza, Brazil, 60336-045
    - Recruiting
    - Research Site
  - Goiânia, Brazil, 74110-060
    - Not yet recruiting
    - Research Site
  - Natal, Brazil, 59075-740
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 90619-900
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 98850-170
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 90570-060
    - Not yet recruiting
    - Research Site
  - Porto Velho, Brazil, 76834-899
    - Recruiting
    - Research Site
  - Recife, Brazil, 52010-075
    - Recruiting
    - Research Site
  - Rio de Janeiro, Brazil, 20220-410
    - Recruiting
    - Research Site
  - Salvador, Brazil, 40050 410
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 01246-000
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 1323001
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 01323-000
    - Not yet recruiting
    - Research Site
  - Teresina, Brazil, 64049-200
    - Recruiting
    - Research Site
Canada
- Ontario
  - Hamilton, Ontario, Canada, L8V 1C3
    - Recruiting
    - Research Site
  - London, Ontario, Canada, N6A 5W9
    - Withdrawn
    - Research Site
  - Toronto, Ontario, Canada, M4N 3M5
    - Recruiting
    - Research Site
  - Toronto, Ontario, Canada, M5G 2M9
    - Recruiting
    - Research Site
- Quebec
  - Montreal, Quebec, Canada, H3G 1A4
    - Recruiting
    - Research Site
  - Montreal, Quebec, Canada, H2X 0C1
    - Recruiting
    - Research Site
  - Ste-Foy, Quebec, Canada, G1V 4G2
    - Withdrawn
    - Research Site
China
- - Beijing, China, 100730
    - Recruiting
    - Research Site
  - Beijing, China, 100142
    - Recruiting
    - Research Site
  - Beijing, China, 100026
    - Not yet recruiting
    - Research Site
  - Changde, China, 415000
    - Recruiting
    - Research Site
  - Changsha, China, 410008
    - Recruiting
    - Research Site
  - Changsha, China, 410013
    - Recruiting
    - Research Site
  - Chengdu, China, 610041
    - Recruiting
    - Research Site
  - Chengdu, China, 610044
    - Recruiting
    - Research Site
  - Chongqing, China, 400030
    - Recruiting
    - Research Site
  - Fuzhou, China, 350014
    - Recruiting
    - Research Site
  - Ganzhou, China, 341000
    - Recruiting
    - Research Site
  - Guangzhou, China, 510060
    - Recruiting
    - Research Site
  - Guangzhou, China, 510120
    - Withdrawn
    - Research Site
  - Hangzhou, China, 310022
    - Recruiting
    - Research Site
  - Harbin, China, 150081
    - Recruiting
    - Research Site
  - Kunming, China, 650118
    - Recruiting
    - Research Site
  - Lanzhou, China, 730000
    - Recruiting
    - Research Site
  - Lanzhou, China, 730050
    - Recruiting
    - Research Site
  - Linyi, China, 276001
    - Recruiting
    - Research Site
  - Luzhou, China, 646000
    - Withdrawn
    - Research Site
  - Nanchang, China, 330006
    - Recruiting
    - Research Site
  - Nanchang, China, 330029
    - Recruiting
    - Research Site
  - Shandong, China
    - Withdrawn
    - Research Site
  - Shanghai, China, 200032
    - Recruiting
    - Research Site
  - Shanghai, China, 200080
    - Recruiting
    - Research Site
  - Shenyang, China, 110004
    - Recruiting
    - Research Site
  - Shenzhen, China, 518036
    - Recruiting
    - Research Site
  - Shenzhen, China, 518116
    - Recruiting
    - Research Site
  - Tianjin, China, 300060
    - Recruiting
    - Research Site
  - Wuhan, China, 430022
    - Recruiting
    - Research Site
  - Wuhan, China, 430030
    - Recruiting
    - Research Site
  - Xi'an, China, 710061
    - Recruiting
    - Research Site
  - Yibin, China, 610500
    - Withdrawn
    - Research Site
  - Yinchuan, China, 750004
    - Recruiting
    - Research Site
  - Zhengzhou, China, 450008
    - Recruiting
    - Research Site
  - Zhengzhou, China, 450052
    - Terminated
    - Research Site
  - Zhuzhou, China, 412007
    - Recruiting
    - Research Site
Denmark
- - Aarhus N, Denmark, 8200
    - Recruiting
    - Research Site
  - København Ø, Denmark, 2100
    - Recruiting
    - Research Site
  - Odense, Denmark, 5000
    - Recruiting
    - Research Site
Germany
- - Berlin, Germany, 13353
    - Recruiting
    - Research Site
  - Bonn, Germany, 53127
    - Recruiting
    - Research Site
  - Hamburg, Germany, 20246
    - Recruiting
    - Research Site
  - Leipzig, Germany, 04103
    - Recruiting
    - Research Site
India
- - Calicut, India, 673601
    - Terminated
    - Research Site
  - Jaipur, India, 302017
    - Recruiting
    - Research Site
  - Lucknow, India, 226003
    - Withdrawn
    - Research Site
  - Madurai, India, 625107
    - Recruiting
    - Research Site
  - Mohali, India, 160055
    - Withdrawn
    - Research Site
  - Nagpur, India, 440001
    - Recruiting
    - Research Site
  - Nashik, India, 422009
    - Recruiting
    - Research Site
  - Nashik, India, 422011
    - Recruiting
    - Research Site
  - New Delhi, India, 11029
    - Recruiting
    - Research Site
  - Vadodara, India, 391760
    - Recruiting
    - Research Site
Italy
- - Bari, Italy, 70124
    - Withdrawn
    - Research Site
  - Bologna, Italy, 40138
    - Recruiting
    - Research Site
  - Catania, Italy, 95126
    - Recruiting
    - Research Site
  - Florence, Italy, 50141
    - Recruiting
    - Research Site
  - Lecco, Italy, 23900
    - Completed
    - Research Site
  - Milan, Italy, 20141
    - Recruiting
    - Research Site
  - Milan, Italy, 20159
    - Recruiting
    - Research Site
  - Milan, Italy, 20133
    - Recruiting
    - Research Site
  - Monza, Italy, 20900
    - Recruiting
    - Research Site
  - Naples, Italy, 80131
    - Recruiting
    - Research Site
  - Roma, Italy, 161
    - Recruiting
    - Research Site
  - Rome, Italy, 00168
    - Recruiting
    - Research Site
  - Turin, Italy, 10128
    - Recruiting
    - Research Site
Japan
- - Fukuoka, Japan, 812-8582
    - Recruiting
    - Research Site
  - Ginowan-shi, Japan, 901-2725
    - Recruiting
    - Research Site
  - Hidaka-shi, Japan, 350-1298
    - Recruiting
    - Research Site
  - Kagoshima, Japan, 890-8520
    - Recruiting
    - Research Site
  - Kurume-shi, Japan, 830-0011
    - Recruiting
    - Research Site
  - Kōtoku, Japan, 135-8550
    - Recruiting
    - Research Site
  - Maebashi, Japan, 371-8511
    - Recruiting
    - Research Site
  - Matsuyama, Japan, 791-0280
    - Recruiting
    - Research Site
  - Morioka, Japan, 028-3695
    - Recruiting
    - Research Site
  - Nagoya, Japan, 464-8681
    - Recruiting
    - Research Site
  - Osaka, Japan, 541-8567
    - Withdrawn
    - Research Site
  - Sapporo, Japan, 003-0804
    - Recruiting
    - Research Site
  - Sapporo, Japan, 060-8638
    - Withdrawn
    - Research Site
  - Shinjuku-ku, Japan, 160-8582
    - Recruiting
    - Research Site
  - Suita-shi, Japan, 565-0871
    - Recruiting
    - Research Site
  - Sunto-gun, Japan, 411-8777
    - Recruiting
    - Research Site
  - Toon-Shi, Japan, 791-0295
    - Recruiting
    - Research Site
Mexico
- - Coyoacán, Mexico, 04380
    - Recruiting
    - Research Site
  - Culiacán, Mexico, 80040
    - Withdrawn
    - Research Site
  - Guadalajara, Mexico, 44650
    - Recruiting
    - Research Site
  - Guadalajra, Mexico, 44260
    - Withdrawn
    - Research Site
  - Mexico City, Mexico, 03240
    - Recruiting
    - Research Site
  - Monterrey, Mexico, 64460
    - Recruiting
    - Research Site
  - México, Mexico, 04700
    - Recruiting
    - Research Site
  - México, Mexico, 14080
    - Withdrawn
    - Research Site
Norway
- - Oslo, Norway, 424
    - Recruiting
    - Research Site
  - Trondheim, Norway, 7030
    - Recruiting
    - Research Site
Peru
- - Concepción, Peru, 12125
    - Terminated
    - Research Site
  - Lima, Peru, LIMA 29
    - Recruiting
    - Research Site
  - Lima, Peru, 15036
    - Recruiting
    - Research Site
  - Lima, Peru, Lima 34
    - Not yet recruiting
    - Research Site
  - Lima, Peru, 15038
    - Recruiting
    - Research Site
  - Lima, Peru, 15102
    - Recruiting
    - Research Site
  - Lima, Peru, Lima39
    - Recruiting
    - Research Site
Poland
- - Bialystok, Poland, 15-027
    - Recruiting
    - Research Site
  - Gdansk, Poland, 80-214
    - Recruiting
    - Research Site
  - Gliwice, Poland, 44-101
    - Recruiting
    - Research Site
  - Krakow, Poland, 30-348
    - Withdrawn
    - Research Site
  - Lodz, Poland, 90-513
    - Withdrawn
    - Research Site
  - Poznan, Poland, 61-866
    - Recruiting
    - Research Site
  - Warsaw, Poland, 02-781
    - Withdrawn
    - Research Site
  - Wroclaw, Poland, 53-413
    - Recruiting
    - Research Site
Puerto Rico
- - San Juan, Puerto Rico, 00927
    - Withdrawn
    - Research Site
South Korea
- - Daegu, South Korea, 42601
    - Recruiting
    - Research Site
  - Goyang-si, South Korea, 10408
    - Recruiting
    - Research Site
  - Gyeonggi-do, South Korea, 13605
    - Recruiting
    - Research Site
  - Seoul, South Korea, 03080
    - Recruiting
    - Research Site
  - Seoul, South Korea, 06351
    - Recruiting
    - Research Site
  - Seoul, South Korea, 5505
    - Recruiting
    - Research Site
  - Seoul, South Korea, 03722
    - Recruiting
    - Research Site
Spain
- - A Coruña, Spain, 15009
    - Recruiting
    - Research Site
  - Barcelona, Spain, 08036
    - Recruiting
    - Research Site
  - Barcelona, Spain, 8035
    - Recruiting
    - Research Site
  - Córdoba, Spain, 14004
    - Recruiting
    - Research Site
  - Girona, Spain, 17007
    - Recruiting
    - Research Site
  - Hospitalet deLlobregat, Spain, 08907
    - Recruiting
    - Research Site
  - Madrid, Spain, 28034
    - Recruiting
    - Research Site
  - Madrid, Spain, 28040
    - Recruiting
    - Research Site
  - Madrid, Spain, 28041
    - Recruiting
    - Research Site
  - Madrid, Spain, 28046
    - Withdrawn
    - Research Site
  - Palma de Mallorca, Spain, 07010
    - Withdrawn
    - Research Site
  - Valencia, Spain, 46010
    - Withdrawn
    - Research Site
  - Valencia, Spain, 46009
    - Recruiting
    - Research Site
Taiwan
- - Changhua, Taiwan, 50006
    - Recruiting
    - Research Site
  - Kaohsiung City, Taiwan, 833
    - Recruiting
    - Research Site
  - Kaohsiung City, Taiwan, 81362
    - Recruiting
    - Research Site
  - New Taipei City, Taiwan, 220
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 40447
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 40705
    - Recruiting
    - Research Site
  - Tainan, Taiwan, 704
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 11217
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 10449
    - Recruiting
    - Research Site
  - Taoyuan, Taiwan, 333
    - Recruiting
    - Research Site
Thailand
- - Bangkok, Thailand, 10400
    - Recruiting
    - Research Site
  - Bangkok, Thailand, 10330
    - Recruiting
    - Research Site
  - Bangkok, Thailand, 10700
    - Recruiting
    - Research Site
  - Muang, Thailand, 50200
    - Recruiting
    - Research Site
  - Udon Thani, Thailand, 41330
    - Recruiting
    - Research Site
Turkey (Türkiye)
- - Adana, Turkey (Türkiye), 01250
    - Recruiting
    - Research Site
  - Ankara, Turkey (Türkiye), 06100
    - Recruiting
    - Research Site
  - Ankara, Turkey (Türkiye), 06490
    - Recruiting
    - Research Site
  - Cordaleo, Turkey (Türkiye), 35575
    - Recruiting
    - Research Site
  - Istanbul, Turkey (Türkiye), 32098
    - Withdrawn
    - Research Site
  - Istanbul, Turkey (Türkiye), 34214
    - Withdrawn
    - Research Site
United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - Withdrawn
    - Research Site
- Arizona
  - Phoenix, Arizona, United States, 85016
    - Withdrawn
    - Research Site
  - Tucson, Arizona, United States, 85711
    - Withdrawn
    - Research Site
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Withdrawn
    - Research Site
- California
  - La Jolla, California, United States, 92093
    - Withdrawn
    - Research Site
  - West Hollywood, California, United States, 90048
    - Withdrawn
    - Research Site
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Withdrawn
    - Research Site
  - Augusta, Georgia, United States, 30912
    - Withdrawn
    - Research Site
  - Savannah, Georgia, United States, 31405
    - Terminated
    - Research Site
- Illinois
  - Melrose Park, Illinois, United States, 60160
    - Withdrawn
    - Research Site
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Withdrawn
    - Research Site
- Louisiana
  - New Orleans, Louisiana, United States, 70112
    - Withdrawn
    - Research Site
  - New Orleans, Louisiana, United States, 70121
    - Withdrawn
    - Research Site
  - Shreveport, Louisiana, United States, 71103
    - Completed
    - Research Site
- New York
  - New York, New York, United States, 10016
    - Withdrawn
    - Research Site
  - Syracuse, New York, United States, 13210
    - Withdrawn
    - Research Site
- Ohio
  - Cleveland, Ohio, United States, 44195
    - Withdrawn
    - Research Site
  - Columbus, Ohio, United States, 43210
    - Withdrawn
    - Research Site
- Oregon
  - Eugene, Oregon, United States, 97401
    - Withdrawn
    - Research Site
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19107
    - Withdrawn
    - Research Site
- Rhode Island
  - Providence, Rhode Island, United States, 02905
    - Withdrawn
    - Research Site
- Texas
  - Dallas, Texas, United States, 75390
    - Withdrawn
    - Research Site
  - Fort Worth, Texas, United States, 76104
    - Terminated
    - Research Site
  - Houston, Texas, United States, 77030
    - Withdrawn
    - Research Site
  - Tyler, Texas, United States, 75702
    - Withdrawn
    - Research Site
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - Completed
    - Research Site
  - Fairfax, Virginia, United States, 22031
    - Withdrawn
    - Research Site
  - Richmond, Virginia, United States, 23298
    - Withdrawn
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo IV Infusion Other Names: Saline
Experimental: Volrustomig	Biological: Volrustomig IV Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS) based on the investigator assessment in all randomized participants (FAS) Time Frame: 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) in all randomized participants Time Frame: 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 Time Frame: 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 Time Frame: 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 Time Frame: 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 Time Frame: 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 Time Frame: 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 Time Frame: 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 Time Frame: 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 Time Frame: 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 Time Frame: 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 Time Frame: 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 Time Frame: 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 Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Gynecologic Oncology Group Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2023

Primary Completion (Estimated)

November 26, 2027

Study Completion (Estimated)

September 30, 2030

Study Registration Dates

First Submitted

September 4, 2023

First Submitted That Met QC Criteria

October 6, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

D7984C00002
GOG-3092 (Other Identifier: Gynecologic Oncology Group Foundation)
ENGOT-cx19/GEICO (Other Identifier: European Network for Gynaecological Oncological Trial groups)
165663 (Registry Identifier: FDA-IND)
2023-504374-38-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Sharing Time Frame

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 Sharing Access Criteria

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 Sharing Supporting Information Type

STUDY_PROTOCOL
SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Locally Advanced Cervical Cancer

Clinical Trials on Placebo

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