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

Exclusion Criteria

• •Diagnosis of small cell (neuroendocrine) or mucinous adenocarcinoma of cervical cancer.
• •Evidence of metastatic disease.
• •Intent to administer a fertility-sparing treatment regimen.
• •History of organ transplant or allogenic stem cell transplant.
• •Active or prior documented autoimmune or inflammatory disorders.
• •Uncontrolled intercurrent illness.
• •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.
• •History of anaphylaxis to any biologic therapy or vaccine.
• •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.
• •Participants with a known allergy or hypersensitivity to the study intervention, or any excipients of the study intervention.