A Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (IVOLGA)
A Phase II Single-arm Multi-centre Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer Who Have Not Progressed Following Platinum Based, Concurrent Chemoradiation Therapy
Sponsor: AstraZeneca
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Progression-free Survival at 24 months (PFS24)
Time frame: From date of first dose until 24 months.
Secondary Endpoints
Overall Survival at 36 months (OS36)
Progression-free Survival at 36 months (PFS36)
Time to First Subsequent Therapy or death (TFST)
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 fertili…
Read full criteria on CT.gov →✦ Analyst Commentary
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