Locally Advanced Cervical CancerPhase 3eVOLVECervicalNCT06079671
Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical)
A Phase 3 study testing Volrustomig in people with Locally Advanced Cervical Cancer, run by AstraZeneca at 205 sites in 19 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Locally Advanced Cervical Cancer
- What is being tested?
- Volrustomig
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 205 sitesin 19 countries
- Study dates
- 22 Sep 2023to 30 Sep 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
205 sites in 19 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
205 sites in 19 countries
China37 sites, 31 recruiting
- Recruiting
Research Site
Beijing, 100026
- Recruiting
Research Site
Beijing, 100142
- Recruiting
Research Site
Beijing, 100730
- Recruiting
Research Site
Changde, 415000
- Recruiting
Research Site
Changsha, 410008
- Recruiting
Research Site
Changsha, 410013
- Recruiting
Research Site
Chengdu, 610041
- Recruiting
Research Site
Chengdu, 610044
- Recruiting
Research Site
Chongqing, 400030
- Recruiting
Research Site
Fuzhou, 350014
- Recruiting
Research Site
Ganzhou, 341000
- Recruiting
Research Site
Guangzhou, 510060
- Withdrawn
Research Site
Guangzhou, 510120
- Recruiting
Research Site
Hangzhou, 310022
- Recruiting
Research Site
Harbin, 150081
- Recruiting
Research Site
Kunming, 650118
- Completed
Research Site
Lanzhou, 730000
- Recruiting
Research Site
Lanzhou, 730050
- Recruiting
Research Site
Linyi, 276001
- Withdrawn
Research Site
Luzhou, 646000
- Recruiting
Research Site
Nanchang, 330006
- Recruiting
Research Site
Nanchang, 330029
- Withdrawn
Research Site
Shandong
- Recruiting
Research Site
Shanghai, 200032
- Recruiting
Research Site
Shanghai, 200080
- Recruiting
Research Site
Shenyang, 110004
- Recruiting
Research Site
Shenzhen, 518036
- Recruiting
Research Site
Shenzhen, 518116
- Recruiting
Research Site
Tianjin, 300060
- Recruiting
Research Site
Wuhan, 430022
- Recruiting
Research Site
Wuhan, 430030
- Recruiting
Research Site
Xi'an, 710061
- Withdrawn
Research Site
Yibin, 610500
- Recruiting
Research Site
Yinchuan, 750004
- Recruiting
Research Site
Zhengzhou, 450008
- Terminated
Research Site
Zhengzhou, 450052
- Recruiting
Research Site
Zhuzhou, 412007
United States28 sites
- Withdrawn
Research Site
Atlanta, Georgia, 30322
- Withdrawn
Research Site
Augusta, Georgia, 30912
- Withdrawn
Research Site
Birmingham, Alabama, 35233
- Completed
Research Site
Charlottesville, Virginia, 22908
- Withdrawn
Research Site
Cleveland, Ohio, 44195
- Withdrawn
Research Site
Columbus, Ohio, 43210
- Withdrawn
Research Site
Dallas, Texas, 75390
- Withdrawn
Research Site
Eugene, Oregon, 97401
- Withdrawn
Research Site
Fairfax, Virginia, 22031
- Terminated
Research Site
Fort Worth, Texas, 76104
- Withdrawn
Research Site
Houston, Texas, 77030
- Withdrawn
Research Site
Indianapolis, Indiana, 46202
- Withdrawn
Research Site
La Jolla, California, 92093
- Withdrawn
Research Site
Little Rock, Arkansas, 72205
- Withdrawn
Research Site
Melrose Park, Illinois, 60160
- Withdrawn
Research Site
New Orleans, Louisiana, 70112
- Withdrawn
Research Site
New Orleans, Louisiana, 70121
- Withdrawn
Research Site
New York, New York, 10016
- Withdrawn
Research Site
Philadelphia, Pennsylvania, 19107
- Withdrawn
Research Site
Phoenix, Arizona, 85016
- Withdrawn
Research Site
Providence, Rhode Island, 02905
- Withdrawn
Research Site
Richmond, Virginia, 23298
- Terminated
Research Site
Savannah, Georgia, 31405
- Completed
Research Site
Shreveport, Louisiana, 71103
- Withdrawn
Research Site
Syracuse, New York, 13210
- Withdrawn
Research Site
Tucson, Arizona, 85711
- Withdrawn
Research Site
Tyler, Texas, 75702
- Withdrawn
Research Site
West Hollywood, California, 90048
Brazil19 sites, 19 recruiting
- Recruiting
Research Site
Barretos, 14784-400
- Recruiting
Research Site
Belo Horizonte, 30130-100
- Recruiting
Research Site
Curitiba, 80730-150
- Recruiting
Research Site
Fortaleza, 60336-045
- Recruiting
Research Site
Fortaleza, 60430-230
- Not yet recruiting
Research Site
Goiânia, 74110-060
- Not yet recruiting
Research Site
Ijuí, 98700-000
- Recruiting
Research Site
Natal, 59075-740
- Recruiting
Research Site
Porto Alegre, 90570-060
- Recruiting
Research Site
Porto Alegre, 90619-900
- Recruiting
Research Site
Porto Alegre, 98850-170
- Recruiting
Research Site
Porto Velho, 76834-899
- Recruiting
Research Site
Recife, 52010-075
- Recruiting
Research Site
Rio de Janeiro, 20220-410
- Recruiting
Research Site
Salvador, 40050 410
- Recruiting
Research Site
São Paulo, 01246-000
- Not yet recruiting
Research Site
São Paulo, 01323-000
- Recruiting
Research Site
São Paulo, 1323001
- Recruiting
Research Site
Teresina, 64049-200
Japan17 sites, 15 recruiting
- Recruiting
Research Site
Fukuoka, 812-8582
- Recruiting
Research Site
Ginowan-shi, 901-2725
- Recruiting
Research Site
Hidaka-shi, 350-1298
- Recruiting
Research Site
Kagoshima, 890-8520
- Recruiting
Research Site
Kōtoku, 135-8550
- Recruiting
Research Site
Kurume-shi, 830-0011
- Recruiting
Research Site
Maebashi, 371-8511
- Recruiting
Research Site
Matsuyama, 791-0280
- Recruiting
Research Site
Morioka, 028-3695
- Recruiting
Research Site
Nagoya, 464-8681
- Withdrawn
Research Site
Osaka, 541-8567
- Recruiting
Research Site
Sapporo, 003-0804
- Withdrawn
Research Site
Sapporo, 060-8638
- Recruiting
Research Site
Shinjuku-ku, 160-8582
- Recruiting
Research Site
Suita-shi, 565-0871
- Recruiting
Research Site
Sunto-gun, 411-8777
- Recruiting
Research Site
Toon-Shi, 791-0295
Italy13 sites, 11 recruiting
- Withdrawn
Research Site
Bari, 70124
- Recruiting
Research Site
Bologna, 40138
- Recruiting
Research Site
Catania, 95126
- Recruiting
Research Site
Florence, 50141
- Completed
Research Site
Lecco, 23900
- Recruiting
Research Site
Milan, 20133
- Recruiting
Research Site
Milan, 20141
- Recruiting
Research Site
Milan, 20159
- Recruiting
Research Site
Monza, 20900
- Recruiting
Research Site
Naples, 80131
- Recruiting
Research Site
Roma, 161
- Recruiting
Research Site
Rome, 00168
- Recruiting
Research Site
Turin, 10128
Spain13 sites, 10 recruiting
- Recruiting
Research Site
A Coruña, 15009
- Recruiting
Research Site
Barcelona, 08036
- Recruiting
Research Site
Barcelona, 8035
- Recruiting
Research Site
Córdoba, 14004
- Recruiting
Research Site
Girona, 17007
- Recruiting
Research Site
Hospitalet deLlobregat, 08907
- Recruiting
Research Site
Madrid, 28034
- Recruiting
Research Site
Madrid, 28040
- Recruiting
Research Site
Madrid, 28041
- Withdrawn
Research Site
Madrid, 28046
- Withdrawn
Research Site
Palma de Mallorca, 07010
- Recruiting
Research Site
Valencia, 46009
- Withdrawn
Research Site
Valencia, 46010
India10 sites, 7 recruiting
- Terminated
Research Site
Calicut, 673601
- Recruiting
Research Site
Jaipur, 302017
- Withdrawn
Research Site
Lucknow, 226003
- Recruiting
Research Site
Madurai, 625107
- Withdrawn
Research Site
Mohali, 160055
- Recruiting
Research Site
Nagpur, 440001
- Recruiting
Research Site
Nashik, 422009
- Recruiting
Research Site
Nashik, 422011
- Recruiting
Research Site
New Delhi, 110029
- Recruiting
Research Site
Vadodara, 391760
Taiwan10 sites, 10 recruiting
- Recruiting
Research Site
Changhua, 50006
- Recruiting
Research Site
Kaohsiung City, 81362
- Recruiting
Research Site
Kaohsiung City, 833
- Recruiting
Research Site
New Taipei City, 220
- Recruiting
Research Site
Taichung, 40447
- Recruiting
Research Site
Taichung, 40705
- Recruiting
Research Site
Tainan, 704
- Recruiting
Research Site
Taipei, 10449
- Recruiting
Research Site
Taipei, 11217
- Recruiting
Research Site
Taoyuan, 333
Mexico8 sites, 5 recruiting
- Recruiting
Research Site
Coyoacán, 04380
- Withdrawn
Research Site
Culiacán, 80040
- Recruiting
Research Site
Guadalajara, 44650
- Withdrawn
Research Site
Guadalajra, 44260
- Recruiting
Research Site
México, 04700
- Withdrawn
Research Site
México, 14080
- Recruiting
Research Site
Mexico City, 03240
- Recruiting
Research Site
Monterrey, 64460
Poland8 sites, 5 recruiting
- Recruiting
Research Site
Bialystok, 15-027
- Recruiting
Research Site
Gdansk, 80-214
- Recruiting
Research Site
Gliwice, 44-101
- Withdrawn
Research Site
Krakow, 30-348
- Withdrawn
Research Site
Lodz, 90-513
- Recruiting
Research Site
Poznan, 61-866
- Withdrawn
Research Site
Warsaw, 02-781
- Recruiting
Research Site
Wroclaw, 53-413
Canada7 sites, 5 recruiting
- Recruiting
Research Site
Hamilton, Ontario, L8V 1C3
- Withdrawn
Research Site
London, Ontario, N6A 5W9
- Recruiting
Research Site
Montreal, Quebec, H2X 0C1
- Recruiting
Research Site
Montreal, Quebec, H3G 1A4
- Withdrawn
Research Site
Ste-Foy, Quebec, G1V 4G2
- Recruiting
Research Site
Toronto, Ontario, M4N 3M5
- Recruiting
Research Site
Toronto, Ontario, M5G 2M9
Peru7 sites, 6 recruiting
- Terminated
Research Site
Concepción, 12125
- Recruiting
Research Site
Lima, 15036
- Recruiting
Research Site
Lima, 15038
- Recruiting
Research Site
Lima, 15102
- Recruiting
Research Site
Lima, LIMA 29
- Recruiting
Research Site
Lima, Lima 34
- Recruiting
Research Site
Lima, Lima39
South Korea7 sites, 7 recruiting
- Recruiting
Research Site
Daegu, 42601
- Recruiting
Research Site
Goyang-si, 10408
- Recruiting
Research Site
Gyeonggi-do, 13605
- Recruiting
Research Site
Seoul, 03080
- Recruiting
Research Site
Seoul, 03722
- Recruiting
Research Site
Seoul, 06351
- Recruiting
Research Site
Seoul, 5505
Turkey (Türkiye)6 sites, 3 recruiting
- Recruiting
Research Site
Adana, 01250
- Withdrawn
Research Site
Ankara, 06100
- Recruiting
Research Site
Ankara, 06490
- Recruiting
Research Site
Cordaleo, 35575
- Withdrawn
Research Site
Istanbul, 32098
- Withdrawn
Research Site
Istanbul, 34214
Thailand5 sites, 5 recruiting
- Recruiting
Research Site
Bangkok, 10330
- Recruiting
Research Site
Bangkok, 10400
- Recruiting
Research Site
Bangkok, 10700
- Recruiting
Research Site
Muang, 50200
- Recruiting
Research Site
Udon Thani, 41330
Germany4 sites, 4 recruiting
- Recruiting
Research Site
Berlin, 13353
- Recruiting
Research Site
Bonn, 53127
- Recruiting
Research Site
Hamburg, 20246
- Recruiting
Research Site
Leipzig, 04103
Denmark3 sites, 3 recruiting
- Recruiting
Research Site
Aarhus N, 8200
- Recruiting
Research Site
København Ø, 2100
- Recruiting
Research Site
Odense, 5000
Norway2 sites, 2 recruiting
- Recruiting
Research Site
Oslo, 424
- Recruiting
Research Site
Trondheim, 7030
About this study
Official title: 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.
Read the detailed description
Women with locally advanced cervical cancer will be randomized in a 1:1 ratio to receive treatment with Volrustomig or Placebo.
- Conditions
- Locally Advanced Cervical Cancer
- Being tested
- Volrustomig, Placebo
- Keywords
- Locally Advanced Cervical Cancer;, Adolescent and Young Adult;, Volrustomig
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VolrustomigBiological
IV Infusion
PlaceboOther
Also called Saline
IV Infusion
| Study group | Role | What they receive |
|---|---|---|
| Volrustomig | Experimental | Volrustomig Receives: Biological: Volrustomig |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) based on the investigator assessment in all randomized participants (FAS)
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.
Measured: Up to approximately 7 years
Secondary outcomes (13)
Overall Survival (OS) in all randomized participants
OS defined as time from randomization until the date of death due to any cause.
Measured: Up to approximately 7 years
Objective Response Rate (ORR) in all randomized participants
ORR is defined as the proportion of participants who have a CR or PR, as determined by Investigator per RECIST 1.1
Measured: Up to approximately 7 years
Duration of Response (DoR) in all randomized participants
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.
Measured: Up to approximately 7 years
Time to First Subsequent Therapy or death (TFST) in all randomized participants
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.
Measured: Up to approximately 7 years
Time to second progression or death (PFS2) in all randomized participants
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.
Measured: Up to approximately 7 years
PFS by BICR in all randomized participants
Endpoints based on the PFS by BICR assessment according to RECIST 1.1.
Measured: Up to approximately 7 years
The incidence of local progression, and distant disease progression as the first documented progression event in all randomized participants
Incidence of Local Progression, and Distant Disease Progression: Number and percentage of participants who develop local progression, distant disease recurrence.
Measured: Up to approximately 7 years
PK of volrustomig
Concentration of volrustomig in serum and PK parameters as data allow.
Measured: Up to approximately 7 years
The immunogenicity of volrustomig
Incidence of ADAs against volrustomig in serum.
Measured: Up to approximately 7 years
Incidence of adverse events of volrustomig compared to placebo
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.
Measured: Up to approximately 7 years
Participant-reported disease-related symptoms
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.
Measured: Up to approximately 7 years
Participant-reported physical functioning
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.
Measured: Up to approximately 7 years
Participant-reported global health status/Quality of Life
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.
Measured: Up to approximately 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start22 Sep 2023
- Primary completion26 Nov 2027 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Cervical CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gynecologic Oncology Group Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079671
- Sponsor's protocol ID
- D7984C00002
- Other IDs
- GOG-3092, ENGOT-cx19/GEICO, 165663, 2023-504374-38-00, 2023
- Acronym
- eVOLVECervical
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2023
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06079671
- Acronym / sponsor ID
- eVOLVECervical / D7984C00002
- Conditions
- Locally Advanced Cervical Cancer
- Keywords
- Locally Advanced Cervical Cancer;, Adolescent and Young Adult;, Volrustomig
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Gynecologic Oncology Group Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT)
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- 26 Nov 2027 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Women with locally advanced cervical cancer will be randomized in a 1:1 ratio to receive treatment with Volrustomig or Placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volrustomig | Experimental | Biological: VolrustomigVolrustomig |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VolrustomigIV Infusion | Biological | Volrustomig |
| PlaceboAlso: SalineIV Infusion | Other | Placebo |
Primary outcome
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.
13 secondary outcomes
Overall Survival (OS) in all randomized participants
Time frame: Up to approximately 7 years
Objective Response Rate (ORR) in all randomized participants
Time frame: Up to approximately 7 years
Duration of Response (DoR) in all randomized participants
Time frame: Up to approximately 7 years
Time to First Subsequent Therapy or death (TFST) in all randomized participants
Time frame: Up to approximately 7 years
Time to second progression or death (PFS2) in all randomized participants
Time frame: Up to approximately 7 years
PFS by BICR in all randomized participants
Time frame: 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
PK of volrustomig
Time frame: Up to approximately 7 years
The immunogenicity of volrustomig
Time frame: Up to approximately 7 years
Incidence of adverse events of volrustomig compared to placebo
Time frame: Up to approximately 7 years
Participant-reported disease-related symptoms
Time frame: Up to approximately 7 years
Participant-reported physical functioning
Time frame: Up to approximately 7 years
Participant-reported global health status/Quality of Life
Time frame: Up to approximately 7 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
205 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Volrustomig in people with Locally Advanced Cervical Cancer, run by AstraZeneca at 205 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 205 sites in China, United States, Brazil, Japan, Italy and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) based on the investigator assessment in all randomized participants (FAS) (time frame: Up to approximately 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.