A Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (IVOLGA)

Prior treatment

• Active or prior documented autoimmune or inflammatory disorders.
• 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.
• 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).
• 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.

Other illness

• Diagnosis of small cell (neuroendocrine) or mucinous adenocarcinoma of cervical cancer.
• Evidence of metastatic disease.
• History of organ transplant or allogenic stem cell transplant.
• Uncontrolled intercurrent illness.
• History of anaphylaxis to any biologic therapy or vaccine.
• Participants with a known allergy or hypersensitivity to the study intervention, or any excipients of the study intervention.

Other

• Patients should not enter the study if any of the following exclusion criteria are fulfilled:
• Intent to administer a fertility-sparing treatment regimen.

• For inclusion in the study, patients should fulfill the following criteria:
• Female.
• Aged at least 18 years at the time of screening.
• 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 42 days prior to the first dose of CCRT.
• Known PD-L1 status.
• Must not have progressed following CCRT.
• World Health Organization/The Eastern Cooperative Oncology Group (WHO/ECOG) performance status of 0 or 1.
• Adequate organ and bone marrow function.
• Capable of providing signed informed consent.