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RecruitingInterventionalPhase 3

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)

NCT ID: NCT06079671Sponsor: AstraZenecaLast updated: 2026-05-27

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.

Detailed description

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

Arms & interventions

  • BiologicalVolrustomig

    IV Infusion

  • OtherPlacebo

    IV Infusion

Outcome measures

Primary

  • 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.

    Time frame: Up to approximately 7 years

Secondary

  • 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

Eligibility criteria

Sex: FemaleAge: 15 Years and olderHealthy volunteers: No
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. Note: Participants \< 18 years of age: physical changes should be aligned with Tanner Stage III. 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 56 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; duration of life expectancy of ≥ 12 weeks. 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 (neuroendocrine) or mucinous adenocarcinoma of cervical cancer. 2. Evidence of metastatic disease. 3. Intent to administer a fertility-sparing treatment regimen. 4. History of organ transplant or allogenic stem cell transplant. 5. History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders. 6. Uncontrolled intercurrent illness. 7. 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. 8. Unresolved toxicities from previous CCRT except for irreversible toxicity that is not reasonably expected to be exacerbated. 9. Prior history or presence of vesicovaginal, colovaginal, or rectovaginal fistula. 10. History of anaphylaxis to any biologic therapy or vaccine. 11. 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. 12. Patients who have undergone a previous hysterectomy, including a supracervical hysterectomy, or will have a hysterectomy as part of their initial cervical cancer therapy. 13. Any prior (besides prior CCRT) or concurrent treatment for cervical cancer. 14. Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery. 15. Exposure to immune mediated therapy prior to the study for any indication. 16. Receipt of live attenuated vaccine within 30 days prior to the first dose of the study intervention. 17. Participants with a known allergy or hypersensitivity to the study intervention, or any excipients of the study intervention.

Study locations (28)

Research Site

Birmingham, Alabama, 35233

Withdrawn

Research Site

Phoenix, Arizona, 85016

Withdrawn

Research Site

Tucson, Arizona, 85711

Withdrawn

Research Site

Little Rock, Arkansas, 72205

Withdrawn

Research Site

La Jolla, California, 92093

Withdrawn

Research Site

West Hollywood, California, 90048

Withdrawn

Research Site

Atlanta, Georgia, 30322

Withdrawn

Research Site

Augusta, Georgia, 30912

Withdrawn

Research Site

Savannah, Georgia, 31405

Terminated

Research Site

Melrose Park, Illinois, 60160

Withdrawn

Research Site

Indianapolis, Indiana, 46202

Withdrawn

Research Site

New Orleans, Louisiana, 70112

Withdrawn

Research Site

New Orleans, Louisiana, 70121

Withdrawn

Research Site

Shreveport, Louisiana, 71103

Completed

Research Site

New York, New York, 10016

Withdrawn

Research Site

Syracuse, New York, 13210

Withdrawn

Research Site

Cleveland, Ohio, 44195

Withdrawn

Research Site

Columbus, Ohio, 43210

Withdrawn

Research Site

Eugene, Oregon, 97401

Withdrawn

Research Site

Philadelphia, Pennsylvania, 19107

Withdrawn

Research Site

Providence, Rhode Island, 02905

Withdrawn

Research Site

Dallas, Texas, 75390

Withdrawn

Research Site

Fort Worth, Texas, 76104

Terminated

Research Site

Houston, Texas, 77030

Withdrawn

Research Site

Tyler, Texas, 75702

Withdrawn

Research Site

Charlottesville, Virginia, 22908

Completed

Research Site

Fairfax, Virginia, 22031

Withdrawn

Research Site

Richmond, Virginia, 23298

Withdrawn