A Phase III, Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With and Following Chemoradiotherapy Compared to Chemoradiotherapy Alone for Treatment in Women With Locally Advanced Cervical Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 770
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression
研究概览
简要总结
This is a randomized, multi-center, double-blind, placebo-controlled, global, Phase III study to determine the efficacy and safety of durvalumab + Chemoradiotherapy versus Chemoradiotherapy alone as treatment in Women With Locally Advanced Cervical Cancer
详细描述
Women will be randomized in a 1:1 ratio to receive treatment with concurrent durvalumab + standard of care (SoC) or Placebo + Soc, followed by durvalumab/placebo maintenance for 24 months.
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)
入排标准
- 年龄范围
- 18 Years 至 130 Years（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
- •Documented evidence of cervical adenocarcinoma or squamous carcinoma FIGO (2009) Stages IB2 to IIB node positive or FIGO (2009) IIIA-IVA any node
- •No prior chemotherapy or radiotherapy for cervical cancer
- •WHO/ECOG performance status of 0-1
- •At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion at baseline.
排除标准
- •Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- •Diagnosis of small cell (neuroendocrine) histology or mucinous adenocarcinoma cervical cancer
- •Intent to administer a fertility-sparing treatment regimen
- •Undergone a previous hysterectomy
- •Evidence of metastatic disease per RECIST 1.1 including lymph nodes ≥15 mm (short axis) above the L1 cephalad body, in the inguinal region or outside the planned radiation field.
- •History of allogeneic organ transplantation
- •Active or prior documented autoimmune or inflammatory disorders
- •Uncontrolled intercurrent illness
- •History of another primary malignancy and active primary immunodeficiency
研究组 & 干预措施
Durvalumab (intravenous infusion)
durvalumab + standard of care concurrent chemoradiation therapy(SoC CCRT) followed by durvalumab monotherapy up to 24 months or until PD from the date of randomization
干预措施: Durvalumab (Biological)
Durvalumab (intravenous infusion)
durvalumab + standard of care concurrent chemoradiation therapy(SoC CCRT) followed by durvalumab monotherapy up to 24 months or until PD from the date of randomization
干预措施: Cisplatin (Drug)
Durvalumab (intravenous infusion)
durvalumab + standard of care concurrent chemoradiation therapy(SoC CCRT) followed by durvalumab monotherapy up to 24 months or until PD from the date of randomization
干预措施: Carboplatin (Drug)
Durvalumab (intravenous infusion)
durvalumab + standard of care concurrent chemoradiation therapy(SoC CCRT) followed by durvalumab monotherapy up to 24 months or until PD from the date of randomization
干预措施: external beam radiation therapy (EBRT) + brachytherapy (Radiation)
Placebo (matching placebo for intravenous infusion)
placebo + standard of care concurrent chemoradiation therapy(SoC CCRT)
干预措施: Cisplatin (Drug)
Placebo (matching placebo for intravenous infusion)
placebo + standard of care concurrent chemoradiation therapy(SoC CCRT)
干预措施: Carboplatin (Drug)
Placebo (matching placebo for intravenous infusion)
placebo + standard of care concurrent chemoradiation therapy(SoC CCRT)
干预措施: external beam radiation therapy (EBRT) + brachytherapy (Radiation)
结局指标
主要结局
Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression
时间窗: Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 months
PFS defined as time from date of randomisation until date of tumour progression or death by any cause, regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression
次要结局
- Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression, PD-L1 Expression >= 1%(Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 months)
- Overall Survival (Count)(Time from date of randomisation until date of death by any cause, assessed up to the data cut-off date (3rd July 2023), assessed up to a maximum of 51.7 months)
- Overall Survival (Duration)(Time from date of randomisation until date of death by any cause, assessed up to the data cut-off date (3rd July 2023), assessed up to a maximum of 51.7 months)
- Objective Response Rate (ORR)(Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 months)
- Complete Response Rate(Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 months)
- Duration of Response (DoR) in Patients With Complete Response (CR)(Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 months)