Phase 3 Study of ADXS11-001 Administered Following Chemoradiation as Adjuvant Treatment for High Risk Locally Advanced Cervical Cancer: AIM2CERV
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Disease Free Survival (DFS)
研究概览
简要总结
Locally advanced cervical cancer at higher risk for recurrence (HRLACC) following concurrent chemotherapy and radiation therapy. This is a group of participants with a significant unmet need. The estimated probability of disease recurrence or death within 4 years of diagnosis is 50% and the prognosis is very grave for those who experience a recurrence.
The purpose of the study was to compare the disease free survival (DFS) of ADXS11-001 to placebo administered following cisplatin-based combination chemotherapy and radiation (CCRT) with curative intent in participants with HRLACC.
详细描述
This was a double-blind, placebo-controlled randomized study of ADXS11-001 administered in the adjuvant setting after completion of CCRT in participants with HRLACC, or death. All eligible participants had received CCRT administered with curative intent according to institutional/national guidelines as well as meeting the minimum standards defined in the protocol. Participants initiated the Screening period within 10 weeks after the completion of CCRT. Baseline radiographic assessments and clinical laboratory assessments were completed no longer than 28 days prior to and 3 days prior to the first study treatment infusion, respectively. Eligible participants were randomized 1:2 to receive either placebo or ADXS11-001. Participants received 1 infusion of study treatment administered every 3 weeks for 3 doses for the first 3 months. Thereafter, participants received study treatment every 8 weeks for a total of 5 doses or until disease recurrence. Participants received a 7-day course of an oral antibiotic or placebo starting 72 hours following the completion of study treatment administration.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants must have a biopsy confirmed diagnosis of squamous cell, adenocarcinoma, or adenosquamous carcinoma of the cervix. Histologic confirmation of the original primary tumor is required.
- •Participants with HRLACC.
- •Participants included those with stage IB2, IIA2, IIB with pelvic lymph node metastases; all FIGO Stage IIIA, IIIB, IVA or any FIGO Stage (except stage IVB) with para-aortic lymph node metastases as defined by the FIGO 2014 staging criteria for carcinoma of the cervix uteri.
- •Participants must have received definitive therapy with curative intent, which consist of at least 4 weeks of treatment with cisplatin and a minimum of 40Gy external beam radiation therapy (EBRT).
- •Have performance status of 0 or 1 on the gynaecologic Oncology Group (GOG) performance scale
- •Demonstrate adequate organ function
排除标准
- •Has not achieved disease-free status after completion of CCRT administered with curative intent.
- •Has International Federation of Gynecology and Obstetrics (FIGO) Stage IVB
- •Has histologies other than squamous cell, adenocarcinoma, or adenosquamous carcinoma of the cervix.
- •Has implanted medical device(s) that pose a high risk for colonization and/or cannot be easily removed (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous implant(s)).
- •Has a contraindication (sensitivity or allergy) to trimethoprim/sulfamethoxazole and ampicillin.
- •Has undergone a previous hysterectomy defined as removal of the entire uterus or will have a hysterectomy as part of their initial cervical cancer therapy. NOTE: Women who have had a partial/subtotal hysterectomy are eligible to participate in the study
研究组 & 干预措施
Placebo
Participants with locally advanced cervical cancer at higher risk for recurrence (HRLACC) received ADXS11-001 matching placebo by intravenous infusion for approximately 60 minutes every 3 weeks for 3 doses (Weeks 1, 4 and 7) and thereafter, every 8 weeks for 5 doses (Weeks 15, 23, 31, 39, and 47) during treatment phase or until disease recurrence. Participants received a 7-day course placebo matching to either trimethoprim/sulfamethoxazole or ampicillin starting 72 hours post treatment in prime and maintenance phase.
干预措施: Placebo (Drug)
ADXS11-001
Participants with HRLACC received ADXS11-001 at a dose of 1x10^9 colony forming units (CFU) by intravenous infusion for approximately 60 minutes every 3 weeks for 3 doses (Weeks 1, 4 and 7) and thereafter, every 8 weeks for 5 doses (Weeks 15, 23, 31, 39, and 47) during treatment phase or until disease recurrence. Participants received a 7-day course of either trimethoprim/sulfamethoxazole or ampicillin starting 72 hours post treatment in prime and maintenance phase.
干预措施: ADXS11-001 (Drug)
结局指标
主要结局
Disease Free Survival (DFS)
时间窗: From the time of randomization to recurrence or death (Maximum duration: 44.7 months)
DFS was defined as the time from randomization until death or recurrence. The date of recurrence was defined as the date of the first time point when recurrence of disease was determined. The determination of recurrence should occur by definitive pathologic tissue confirmation (e.g., biopsy/fine needle aspirate). However, in those cases where it was not medically feasible to obtain a tissue sample then radiographic evidence, when confirmed by independent radiology review, was used to determine recurrence.
次要结局
- Number of Participants With Treatment Emergent Adverse Events(From first dose of study drug until end of study (Up to 44.7 months))
- Overall Survival (OS)(From the date of randomization until death due to any cause (Maximum duration: 44.7 months))