Recruiting NCT06079671

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

Phase III Interventional Locally Advanced Cervical Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Volrustomig, Placebo.
Who it may be relevant to: Registry conditions: Locally Advanced Cervical Cancer. Basic parameters: from 15 years · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Brazil, Canada, China, Denmark +14
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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.

Detailed description

Women with locally advanced cervical cancer will be randomized in a 1:1 ratio to receive treatment with Volrustomig or Placebo.

Interventions

Biological Volrustomig
IV Infusion
Other Placebo
IV Infusion

Primary outcome measures

Progression-free Survival (PFS) based on the investigator assessment in all randomized participants (FAS) [Time frame: Up to approximately 7 years]

Secondary outcome measures (12)

Overall Survival (OS) in all randomized participants [Time frame: Up to approximately 7 years]
Objective Response Rate (ORR) in all randomized participants [Time frame: Up to approximately 7 years]
Duration of Response (DoR) in all randomized participants [Time frame: Up to approximately 7 years]
Time to First Subsequent Therapy or death (TFST) in all randomized participants [Time frame: Up to approximately 7 years]
Time to second progression or death (PFS2) in all randomized participants [Time frame: Up to approximately 7 years]
PFS by BICR in all randomized participants [Time frame: Up to approximately 7 years]
The incidence of local progression, and distant disease progression as the first documented progression event in all randomized participants [Time frame: Up to approximately 7 years]
PK of volrustomig [Time frame: Up to approximately 7 years]
The immunogenicity of volrustomig [Time frame: Up to approximately 7 years]
Incidence of adverse events of volrustomig compared to placebo [Time frame: Up to approximately 7 years]
Participant-reported disease-related symptoms [Time frame: Up to approximately 7 years]
Participant-reported physical functioning [Time frame: Up to approximately 7 years]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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.
History of active primary immunodeficiency or 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); 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.
Participants with a known allergy or hypersensitivity to the study intervention, or any excipients of the study intervention.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment

Study locations

China · 37 centers

Research Site — Beijing
Research Site — Beijing
Research Site — Beijing
Research Site — Changde
Research Site — Changsha
Research Site — Changsha
Research Site — Chengdu
Research Site — Chengdu
… and 29 more centers

United States · 28 centers

Research Site — Birmingham
Research Site — Phoenix
Research Site — Tucson
Research Site — Little Rock
Research Site — La Jolla
Research Site — West Hollywood
Research Site — Atlanta
Research Site — Augusta
… and 20 more centers

Brazil · 19 centers

Research Site — Barretos
Research Site — Belo Horizonte
Research Site — Curitiba
Research Site — Fortaleza
Research Site — Fortaleza
Research Site — Goiânia
Research Site — Ijuí
Research Site — Natal
… and 11 more centers

Japan · 17 centers