NCT06079671 · AstraZeneca
Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical)
(eVOLVECervical)
What this study is about
This is a phase III, randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment, multi-center, global study to explore the effectiveness 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.
View original scientific description
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.
Interventions
BIOLOGICAL
Volrustomig
IV Infusion
OTHER
Placebo
IV Infusion
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- For inclusion in the study, patients should fulfill the following criteria: 1. Female. 2. Aged at least 15 years at the time of screening. 3. Body weight \> 35 kg. 4. Histologically documented FIGO 2018 Stage IIIA to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with no evidence of metastatic disease. 5. Initial staging procedures performed no more than 42 days prior to the first dose of CCRT. 6. Provision of FFPE tumor sample to assess the PD-L1 expression. 7. Must not have progressed following CCRT, participants with persistent disease after definitive CCRT must not be amenable to other available therapies with curative intent. 8. WHO/ECOG performance status of 0 or 1. 9. Adequate organ and bone marrow function. 10. Capable of providing signed informed consent.
Exclusion criteria
- Patients should not enter the study if any of the following exclusion criteria are fulfilled: 1. Diagnosis of small cell (neuroendoc
Where
- Birmingham, Alabama
- Phoenix, Arizona
- Tucson, Arizona
- Little Rock, Arkansas
- La Jolla, California
- West Hollywood, California
- Atlanta, Georgia
- Augusta, Georgia
- Savannah, Georgia
- Melrose Park, Illinois
- Indianapolis, Indiana
- New Orleans, Louisiana
And 15 more locations — see the full list below.
Collaborators
Gynecologic Oncology Group Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 26, 2026 · Source of record for eligibility and locations