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A Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (IVOLGA)
A Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (IVOLGA)
Active Not RecruitingPhase 2
Sponsor: AstraZeneca
Conditions: Locally Advanced Cervical Cancer
Interventions: Volrustomig
Countries: Russia
This is a phase II single-arm open-label study to investigate the efficacy and safety of volrustomig in women with FIGO 2018 stage IIIA to IVA cervical cancer who have not progressed following platinum-based concurrent chemoradiation therapy (CCRT).
Eligibility overview
Sex: FEMALE
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: 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. Exclusion Criteria: Patients should not enter the study if any of the following exclusion criteria are fulfilled: * 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.
Locations (12)
- Arkhangelsk, Russia
- Krasnoyarsk, Russia
- Moscow, Russia
- Moscow, Russia
- Moscow, Russia
- Moscow, Russia
- Moscow, Russia
- Moscow, Russia
- Saint Petersburg, Russia
- Saint Petersburg, Russia
- Ufa, Russia
- Yekaterinburg, Russia