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

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).

Sponsor

AstraZeneca

Recruitment Status

RECRUITING

Study Objective

TREATMENT

ClinicalTrials.gov ID

NCT06943833

Additional Identification number

Last Update Posted

2025-06-11

Study Completion (Actual)

2029-03-30

Study Record Versions

Contacts and Locations

facility: Research Site
status: NOT_YET_RECRUITING
city: Chelyabinsk
zip: 454087
country: Russian Federation
geoPoint: {lat=55.15402, lon=61.42915}

facility: Research Site
status: RECRUITING
city: Moscow
zip: 111123
country: Russian Federation
geoPoint: {lat=55.75222, lon=37.61556}

facility: Research Site
status: RECRUITING
city: Moscow
zip: 115478
country: Russian Federation
geoPoint: {lat=55.75222, lon=37.61556}

facility: Research Site
status: RECRUITING
city: Moscow
zip: 115533
country: Russian Federation
geoPoint: {lat=55.75222, lon=37.61556}

facility: Research Site
status: RECRUITING
city: Moscow
zip: 117997
country: Russian Federation
geoPoint: {lat=55.75222, lon=37.61556}

facility: Research Site
status: NOT_YET_RECRUITING
city: Moscow
zip: 125284
country: Russian Federation
geoPoint: {lat=55.75222, lon=37.61556}

facility: Research Site
status: RECRUITING
city: Moscow
zip: 125367
country: Russian Federation
geoPoint: {lat=55.75222, lon=37.61556}

facility: Research Site
status: RECRUITING
city: Saint Petersburg
zip: 197758
country: Russian Federation
geoPoint: {lat=59.93863, lon=30.31413}

facility: Research Site
status: RECRUITING
city: Yekaterinburg
zip: 620036
country: Russian Federation
geoPoint: {lat=56.8519, lon=60.6122}

Conditions

Locally Advanced Cervical Cancer

TargetDisease

id: M5830
name: Uterine Cervical Neoplasms
asFound: Cervical Cancer
relevance: HIGH

id: M17342
name: Uterine Neoplasms
relevance: LOW

id: M8945
name: Genital Neoplasms, Female
relevance: LOW

id: M17315
name: Urogenital Neoplasms
relevance: LOW

id: M5825
name: Uterine Cervical Diseases
relevance: LOW

id: M17339
name: Uterine Diseases
relevance: LOW

id: M8943
name: Genital Diseases, Female
relevance: LOW

id: M2876
name: Genital Diseases
relevance: LOW

id: M2875
name: Urogenital Diseases
relevance: LOW

id: M27093
name: Female Urogenital Diseases
relevance: LOW

id: M14127
name: Pregnancy Complications
relevance: LOW

id: M8399
name: Female Urogenital Diseases and Pregnancy Complications
relevance: LOW

ProductName

IsActiveControl

IsControlDrug

IsPlacebo

ControlDrug

-

Intervention / Treatment

type: BIOLOGICAL
name: Volrustomig
description: IV infusion
armGroupLabels: [Arm 1]
otherNames: [MEDI5752]

Intervention

Study Type

INTERVENTIONAL

Phase

PHASE2

Allocation

Interventional Model

SINGLE_GROUP

Subject Blind

Arm Label

Open Label

Arm Type

label: Arm 1
type: EXPERIMENTAL
description: Volrustomig
interventionNames: [Biological: Volrustomig]

NumberOfInterventionGroups

0

GroupEnrollment

Target Number of Participant

0

InstitutionLocation

InstitutionPhoneNumber

Study Site

Location Countries

Countries of recruitment

Study Start (Actual)

2025-03-31

Arm Description

All participants will receive volrustomig as IV infusions

Inclusion and Exclusion 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.

minimum age

18 Years

maximum age

Standard ages

ADULT

OLDER_ADULT

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

NO

Enrollment (Actual)

36

Original Enrollment (Actual)

0

Final Enrollment Number

0

FinalSubjectSelectionDate

AnalysisTargetGroup

DemographicInformation

Primary Outcome Measures

measure: Progression-free Survival at 24 months (PFS24)
description: PFS24 is defined as the Kaplan-Meier estimate of PFS at 24 months per RECIST 1.1 or histopathologically confirmed progression as assessed by the Investigator or death due to any cause, whichever occurs earlier.
timeFrame: From date of first dose until 24 months.

Secondary Outcome Measures

measure: Overall Survival at 36 months (OS36)
description: OS36 is defined as the Kaplan-Meier estimate of OS at 36 months after study drug administration.
timeFrame: From date of first dose until 36 months.

measure: Progression-free Survival at 36 months (PFS36)
description: PFS36 is defined as the Kaplan-Meier estimate of PFS at 36 months per RECIST 1.1- defined radiological progression or histopathologically confirmed progression as assessed by the Investigator or death due to any cause, whichever occurs earlier.
timeFrame: From date of first dose until 36 months.

measure: Time to First Subsequent Therapy or death (TFST)
description: TFST: The time from randomization until the start date of the first subsequent anti-cancer therapy after discontinuation of randomized treatment, or death due to any cause.
timeFrame: From date of first dose until 36 months.

PrimaryEndpointResult

Primary Completion Date (Actual)

2028-03-31

ClinicalTrialResultSummary

Telephone

Address

Name

Title

Telephone

name: AstraZeneca Clinical Study Information Center
role: CONTACT
phone: 1-877-240-9479
email: information.center@astrazeneca.com

Affiliation