A Phase II Single-arm Multi-centre Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer Who Have Not Progressed Following Platinum Based, Concurrent Chemoradiation Therapy
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 37
- 试验地点
- 13
- 主要终点
- Progression-free Survival at 24 months (PFS24)
研究概览
简要总结
This is a phase II single-arm open-label study to investigate the efficacy and safety of volrustomig in women with FIGO 2018 stage IIIA to IVA cervical cancer who have not progressed following platinum-based concurrent chemoradiation therapy (CCRT).
详细描述
This is a phase II, single-arm open-label study to explore the efficacy and safety of volrustomig (MEDI5752) in women with high-risk locally advanced cervical cancer (Federation of Gynecologists and Obstetricians (FIGO) 2018 Stage IIIA to IVA) who have not progressed following platinum-based CCRT.
All participants will be assigned to receive volrustomig as intravenous (IV) infusions for up to end of treatment, or until Response Evaluation Criteria in Solid Tumors (RECIST) 1.1-defined radiological progression or histopathologically confirmed progression by Investigator assessment, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.
The results of this study will provide clinical data on efficacy and safety of an innovation treatment in the new region - Russian Federation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 18 Years 至 —（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 18 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.
- •Known PD-L1 status.
- •Must not have progressed following CCRT.
- •World Health Organization/The Eastern Cooperative Oncology Group (WHO/ECOG) performance status of 0 or
- •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.
- •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.
研究组 & 干预措施
Arm 1
Volrustomig
干预措施: Volrustomig (Biological)
结局指标
主要结局
Progression-free Survival at 24 months (PFS24)
时间窗: From date of first dose until 24 months.
PFS24 is defined as the Kaplan-Meier estimate of PFS at 24 months per RECIST 1.1 or histopathologically confirmed progression as assessed by the Investigator or death due to any cause, whichever occurs earlier.
次要结局
- Overall Survival at 36 months (OS36)(From date of first dose until 36 months.)
- Progression-free Survival at 36 months (PFS36)(From date of first dose until 36 months.)
- Time to First Subsequent Therapy or death (TFST)(From date of first dose until 36 months.)