Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-27 @ 11:43 PM
Study NCT ID:
NCT06943833
Status:
RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (IVOLGA)
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IVOLGA
Brief Summary:
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).
Detailed Description:
This is a phase II, single-arm open-label study to explore the efficacy and safety of volrustomig (MEDI5752) in women with high-risk locally advanced cervical cancer (Federation of Gynecologists and Obstetricians (FIGO) 2018 Stage IIIA to IVA) who have not progressed following platinum-based CCRT.
All participants will be assigned to receive volrustomig as intravenous (IV) infusions for up to end of treatment, or until Response Evaluation Criteria in Solid Tumors (RECIST) 1.1-defined radiological progression or histopathologically confirmed progression by Investigator assessment, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.
The results of this study will provide clinical data on efficacy and safety of an innovation treatment in the new region - Russian Federation.
All participants will be assigned to receive volrustomig as intravenous (IV) infusions for up to end of treatment, or until Response Evaluation Criteria in Solid Tumors (RECIST) 1.1-defined radiological progression or histopathologically confirmed progression by Investigator assessment, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.
The results of this study will provide clinical data on efficacy and safety of an innovation treatment in the new region - Russian Federation.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: