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

Eligibility 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.
• 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. 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).
• 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.