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

A vizsgálat adatai

Ki végzi

AstraZeneca

Azonosító

NCT06079671EU 2023-504374-38-00

A regiszteradat frissítve

2026. november 10.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-centre, Global Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer Who Have Not Progressed Following Platinum-based, Concurrent Chemoradiation Therapy (eVOLVE-Cervical)

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.

Bevonási feltételek: For inclusion in the study, patients should fulfill the following criteria:; Female; 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; 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 56 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; duration of life expectancy of ≥ 12 weeks; Adequate organ and bone marrow function; Capable of providing signed informed consent.

Kizáró feltételek: History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders; 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; 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; 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; Diagnosis of small cell (neuroendocrine) or mucinous adenocarcinoma of cervical cancer; Evidence of metastatic disease; History of organ transplant or allogenic stem cell transplant; Uncontrolled intercurrent illness; History of anaphylaxis to any biologic therapy or vaccine; Participants with a known allergy or hypersensitivity to the study intervention, or any excipients of the study intervention; Patients should not enter the study if any of the following exclusion criteria are fulfilled:; Intent to administer a fertility-sparing treatment regimen.

ClinicalTrials.gov NCT06079671 · EU CTIS 2023-504374-38-00