NCT06079671招募中3 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 800
- 试验地点
- 209
- 主要终点
- Progression-free Survival (PFS) based on the investigator assessment in all randomized participants (FAS)
研究概览
简要总结
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.
详细描述
Women with locally advanced cervical cancer will be randomized in a 1:1 ratio to receive treatment with Volrustomig or Placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •For inclusion in the study, patients should fulfill the following criteria:
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Other)
Volrustomig
Experimental
Volrustomig
干预措施: Volrustomig (Biological)
结局指标
主要结局
Progression-free Survival (PFS) based on the investigator assessment in all randomized participants (FAS)
时间窗: Up to approximately 7 years
PFS is defined as the time from date of randomization until RECIST 1.1- defined radiological progression or histopathologically confirmed progression as assessed by the Investigator or death due to any cause, whichever occurs earlier.
次要结局
- Overall Survival (OS) in all randomized participants(Up to approximately 7 years)
- Objective Response Rate (ORR) in all randomized participants(Up to approximately 7 years)
- Duration of Response (DoR) in all randomized participants(Up to approximately 7 years)
- Time to First Subsequent Therapy or death (TFST) in all randomized participants(Up to approximately 7 years)
- Time to second progression or death (PFS2) in all randomized participants(Up to approximately 7 years)
- PFS by BICR in all randomized participants(Up to approximately 7 years)
- The incidence of local progression, and distant disease progression as the first documented progression event in all randomized participants(Up to approximately 7 years)
- PK of volrustomig(Up to approximately 7 years)
- The immunogenicity of volrustomig(Up to approximately 7 years)
- Incidence of adverse events of volrustomig compared to placebo(Up to approximately 7 years)
- Participant-reported disease-related symptoms(Up to approximately 7 years)
- Participant-reported physical functioning(Up to approximately 7 years)
- Participant-reported global health status/Quality of Life(Up to approximately 7 years)
研究者
研究点 (209)
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