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ACTIVE_NOT_RECRUITINGPHASE2

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

NCT06943833•AstraZeneca

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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.
+1 more criteria

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.
+7 more criteria

Locations (12)

Research Site

Arkhangelsk, Russia

Research Site

Krasnoyarsk, Russia

Research Site

Moscow, Russia

Research Site

Moscow, Russia

Research Site

Moscow, Russia

Research Site

Moscow, Russia

Research Site

Moscow, Russia

Research Site

Moscow, Russia

Research Site

Saint Petersburg, Russia

Research Site

Saint Petersburg, Russia

Key Dates

Start Date

March 31, 2025

Primary Completion Date

March 31, 2028

Completion Date

March 30, 2029

Last Updated

January 20, 2026

Enrollment

ACTUAL participants

Conditions

Locally Advanced Cervical Cancer

Interventions

Volrustomig

BIOLOGICAL

MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial

NCT05975593

Locally Advanced Cervical CarcinomaLocally Advanced Cervical Cancer+8 more

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RECRUITINGPHASE2

Neoadjuvant Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer

NCT07104149

Female, Age ≥ 18 Years OldNo Previous Systemic Treatment for the Current Disease, Including Surgery, Antitumor Radiochemotherapy/Immunotherapy+7 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial

Neoadjuvant Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer

Comparing the Efficacy of Surgery Staging and Image Staging of Locally Advanced Cervical Cancer

Study on the Relationship Between Plasma MRD and cfDNA HPV and the Efficacy and Prognosis of Locally Advanced Cervical Cancer After Concurrent Chemoradiotherapy

PD-1 Antibody Plus Chemoradiotherapy for IB2-IIIB Cervical Cancer

Neoadjuvant Ivonescimab Plus Chemotherapy Followed by Concurrent Chemoradiotherapy in High-Risk Locally Advanced Cervical Cancer