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

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 evidenceof metastatic disease.

5. Initial staging procedures performed no more than 42 days prior to the first dose ofCCRT.

6. Provision of FFPE tumor sample to assess the PD-L1 expression.

7. Must not have progressed following CCRT, participants with persistent disease afterdefinitive CCRT must not be amenable to other available therapies with curativeintent.

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 (neuroendocrine) or mucinous adenocarcinoma of cervicalcancer.

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 curativeintent with no known active disease ≥2 years before the first dose of studyintervention; b) Adequately treated nonmelanoma skin cancer or lentigo maligna, orcarcinoma in situ without evidence of disease.

8. Unresolved toxicities from previous CCRT except for irreversible toxicity that isnot 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 firstdose of the study intervention is excluded. The following are exceptions to thiscriterion: a) Intranasal, inhaled, topical steroids, or local steroid injections (eg, intraarticular injection); b) Steroids as premedication for hypersensitivityreactions (eg, CT scan premedication or chemotherapy premedication) or a single dosefor palliative purpose (eg, pain control).

12. Patients who have undergone a previous hysterectomy, including a supracervicalhysterectomy, or will have a hysterectomy as part of their initial cervical cancertherapy.

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 studyintervention 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 thestudy intervention.

17. Participants with a known allergy or hypersensitivity to the study intervention, orany excipients of the study intervention.