NCT06943833

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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
36mo left

Started Mar 2025

Typical duration for phase_2

Geographic Reach
1 country

12 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Mar 2025Mar 2029

First Submitted

Initial submission to the registry

March 11, 2025

Completed
20 days until next milestone

Study Start

First participant enrolled

March 31, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 24, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2029

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

3 years

First QC Date

March 11, 2025

Last Update Submit

January 16, 2026

Conditions

Locally Advanced Cervical Cancer

Keywords

Locally Advanced Cervical Cancer;Volrustomig

Outcome Measures

Primary Outcomes (1)

  • Progression-free Survival at 24 months (PFS24)

    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.

    From date of first dose until 24 months.

Secondary Outcomes (3)

  • Overall Survival at 36 months (OS36)

    From date of first dose until 36 months.

  • Progression-free Survival at 36 months (PFS36)

    From date of first dose until 36 months.

  • Time to First Subsequent Therapy or death (TFST)

    From date of first dose until 36 months.

Other Outcomes (1)

  • Incidence of adverse events of Volrustomig

    From the time of ICF signature up to 48 months.

Study Arms (1)

Arm 1

EXPERIMENTAL

Volrustomig

Biological: Volrustomig

Interventions

VolrustomigBIOLOGICAL

IV infusion

Also known as: MEDI5752
Arm 1

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Research Site

Arkhangelsk, 163045, Russia

Location

Research Site

Krasnoyarsk, 660133, Russia

Location

Research Site

Moscow, 111123, Russia

Location

Research Site

Moscow, 115478, Russia

Location

Research Site

Moscow, 115533, Russia

Location

Research Site

Moscow, 117997, Russia

Location

Research Site

Moscow, 125284, Russia

Location

Research Site

Moscow, 125367, Russia

Location

Research Site

Saint Petersburg, 194291, Russia

Location

Research Site

Saint Petersburg, 197758, Russia

Location

Research Site

Ufa, 450054, Russia

Location

Research Site

Yekaterinburg, 620036, Russia

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Masking Details
Open Label
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All participants will receive volrustomig as IV infusions
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2025

First Posted

April 24, 2025

Study Start

March 31, 2025

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 30, 2029

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
More information

Locations

RU(12)