Status:
RECRUITING
Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical)
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Gynecologic Oncology Group Foundation
European Network for Gynaecological Oncological Trial Groups
Conditions:
Locally Advanced Cervical Cancer
Eligibility:
FEMALE
15+ years
Phase:
PHASE3
Brief 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 IV...
Detailed Description
Women with locally advanced cervical cancer will be randomized in a 1:1 ratio to receive treatment with Volrustomig or Placebo.
Eligibility Criteria
Inclusion
- For inclusion in the study, patients should fulfill the following criteria:
- Female.
- Aged at least 15 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.
- Provision of FFPE tumor sample to assess the PD-L1 expression.
- Must not have progressed following CCRT, participants with persistent disease after definitive CCRT must not be amenable to other available therapies with curative intent.
- WHO/ECOG performance status of 0 or 1.
- Adequate organ and bone marrow function.
- Capable of providing signed informed consent.
Exclusion
- 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.
Key Trial Info
Start Date :
September 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 18 2029
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT06079671
Start Date
September 22 2023
End Date
October 18 2029
Last Update
October 27 2025
Active Locations (195)
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1
Research Site
Birmingham, Alabama, United States, 35233
2
Research Site
Phoenix, Arizona, United States, 85016
3
Research Site
Tucson, Arizona, United States, 85711
4
Research Site
Little Rock, Arkansas, United States, 72205