🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in India / NCT06079671
Recruiting Phase 3

Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical)

NCT06079671 · tracked via the Priya Life Science India tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2023-09-22
Last updated
2026-08-25

Condition(s) studied

Locally Advanced Cervical Cancer

Investigational drug(s) / intervention(s)

VolrustomigPlacebo

Volrustomig: IV Infusion

Placebo: IV Infusion

Study summary

This is a phase III, randomized, double-blind, placebo-controlled, multi-center, global study to explore the efficacy and safety of volrustomig in women with high-risk LACC (FIGO 2018 stage IIIA to IVA cervical cancer) who have not progressed following platinum-based CCRT.

Eligibility

Sex
FEMALE
Min age
15 Years
Max age
Healthy volunteers
No
Inclusion Criteria: For inclusion in the study, patients should fulfill the following criteria: 1. Female. 2. Aged at least 15 years at the time of screening. Note: Participants \< 18 years of age: physical changes should be aligned with Tanner Stage III. 3. Body weight \> 35 kg. 4. Histologically documented FIGO 2018 Stage IIIA to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with no evidence of metastatic disease. 5. Initial staging procedures performed no more than 56 days prior to the first dose of CCRT. 6. Provision of FFPE tumor sample to assess the PD-L1 expression. 7. Must not have progressed following CCRT, participants with persistent disease after definitive CCRT must not be amenable to other available therapies with curative intent. 8. WHO/ECOG performance status of 0 or 1; duration of life expectancy of ≥ 12 weeks. 9. Adequate organ and bone marrow function. 10. Capable of providing signed informed consent. Exclusion Criteria: Patients should not enter the study if any of the following exclusion criteria are fulfilled: 1. Diagnosis of small cell (neuroendocrine) or mucinous adenocarcinoma of cervical cancer. 2. Evidence of metastatic disease. 3. Intent to administer a fertility-sparing treatment regimen. 4. History of organ transplant or allogenic stem cell transplant. 5. History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders. 6. Uncontrolled intercurrent illness. 7. 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. 8. Unresolved toxicities from previous CCRT except for irreversible toxicity that is not reasonably expected to be exacerbated. 9. Prior history or presence of vesicovaginal, colovaginal, or rectovaginal fistula. 10. History of anaphylaxis to any biologic therapy or vaccine. 11. 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); c) Physiologic doses of oral corticosteroids, ie, not exceeding 10 mg/day of prednisone (or equivalent) in the preceding 14 days. 12. Patients who have undergone a previous hysterectomy, including a supracervical hysterectomy, or will have a hysterectomy as part of their initial cervical cancer therapy. 13. Any prior (besides prior CCRT) or concurrent treatment for cervical cancer. 14. Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery. 15. Exposure to immune mediated therapy prior to the study for any indication. 16. Receipt of live attenuated vaccine within 30 days prior to the first dose of the study intervention. 17. Participants with a known allergy or hypersensitivity to the study intervention, or any excipients of the study intervention.

Primary outcome measure(s)

Trial sites (205)

FacilityCityRegionStatus
Research Site Birmingham Alabama Withdrawn
Research Site Phoenix Arizona Withdrawn
Research Site Tucson Arizona Withdrawn
Research Site Little Rock Arkansas Withdrawn
Research Site La Jolla California Withdrawn
Research Site West Hollywood California Withdrawn
Research Site Atlanta Georgia Withdrawn
Research Site Augusta Georgia Withdrawn
Research Site Savannah Georgia Terminated
Research Site Melrose Park Illinois Withdrawn
Research Site Indianapolis Indiana Withdrawn
Research Site New Orleans Louisiana Withdrawn
Research Site New Orleans Louisiana Withdrawn
Research Site Shreveport Louisiana Completed
Research Site New York New York Withdrawn
Research Site Syracuse New York Withdrawn
Research Site Cleveland Ohio Withdrawn
Research Site Columbus Ohio Withdrawn
Research Site Eugene Oregon Withdrawn
Research Site Philadelphia Pennsylvania Withdrawn
Research Site Providence Rhode Island Withdrawn
Research Site Dallas Texas Withdrawn
Research Site Fort Worth Texas Terminated
Research Site Houston Texas Withdrawn
Research Site Tyler Texas Withdrawn
Research Site Charlottesville Virginia Completed
Research Site Fairfax Virginia Withdrawn
Research Site Richmond Virginia Withdrawn
Research Site Barretos Brazil Recruiting
Research Site Belo Horizonte Brazil Recruiting
Research Site Curitiba Brazil Recruiting
Research Site Fortaleza Brazil Recruiting
Research Site Fortaleza Brazil Recruiting
Research Site Goiânia Brazil Not Yet Recruiting
Research Site Ijuí Brazil Not Yet Recruiting
Research Site Natal Brazil Recruiting
Research Site Porto Alegre Brazil Not Yet Recruiting
Research Site Porto Alegre Brazil Recruiting
Research Site Porto Alegre Brazil Recruiting
Research Site Porto Velho Brazil Recruiting

+ 165 more sites — see the full list on the official registry below.

More AstraZeneca trials in India

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06079671 on ClinicalTrials.gov ↗ ← All trials in India