Locally Advanced Cervical CancerPhase 2IVOLGANCT06943833
A Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (IVOLGA)
A Phase 2 study testing Volrustomig in people with Locally Advanced Cervical Cancer, run by AstraZeneca at 12 sites in Russia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Locally Advanced Cervical Cancer
- What is being tested?
- Volrustomig
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 12 sitesRussia
- Study dates
- 31 Mar 2025to 13 Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Russia12 sites
Research Site
Arkhangelsk, 163045
Research Site
Krasnoyarsk, 660133
Research Site
Moscow, 111123
Research Site
Moscow, 115478
Research Site
Moscow, 115533
Research Site
Moscow, 117997
Research Site
Moscow, 125284
Research Site
Moscow, 125367
Research Site
Saint Petersburg, 194291
Research Site
Saint Petersburg, 197758
Research Site
Ufa, 450054
Research Site
Yekaterinburg, 620036
About this study
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
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).
Read the 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.
- Conditions
- Locally Advanced Cervical Cancer
- Being tested
- Volrustomig
- Keywords
- Locally Advanced Cervical Cancer;, Volrustomig
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VolrustomigBiological
Also called MEDI5752
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Volrustomig Receives: Biological: Volrustomig |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of first dose until 24 months.
Secondary outcomes (3)
Overall Survival at 36 months (OS36)
OS36 is defined as the Kaplan-Meier estimate of OS at 36 months after study drug administration.
Measured: From date of first dose until 36 months.
Progression-free Survival at 36 months (PFS36)
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.
Measured: From date of first dose until 36 months.
Time to First Subsequent Therapy or death (TFST)
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.
Measured: From date of first dose until 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start31 Mar 2025
- Primary completion13 Mar 2028 (estimated)
- Study completion13 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Cervical CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive volrustomig as IV infusions
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943833
- Sponsor's protocol ID
- AZ-RU-00011
- Acronym
- IVOLGA
- Status last verified
- Aug 2026
- First submitted
- 11 Mar 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06943833
- Acronym / sponsor ID
- IVOLGA / AZ-RU-00011
- Conditions
- Locally Advanced Cervical Cancer
- Keywords
- Locally Advanced Cervical Cancer;, Volrustomig
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 37 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 13 Mar 2028 (estimated)
- Study completion
- 13 Mar 2029 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive volrustomig as IV infusions
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Biological: VolrustomigVolrustomig |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VolrustomigAlso: MEDI5752IV infusion | Biological | Arm 1 |
Primary outcome
Progression-free Survival at 24 months (PFS24)
Time frame: From date of first dose until 24 months.
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.
3 secondary outcomes
Overall Survival at 36 months (OS36)
Time frame: From date of first dose until 36 months.
Progression-free Survival at 36 months (PFS36)
Time frame: From date of first dose until 36 months.
Time to First Subsequent Therapy or death (TFST)
Time frame: From date of first dose until 36 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Volrustomig in people with Locally Advanced Cervical Cancer, run by AstraZeneca at 12 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival at 24 months (PFS24) (time frame: From date of first dose until 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.