A Phase II Clinical Trial of Chemo-radiotherapy in Combination With INO-3112 in Patients With Locally Advanced Cervical Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS) at 18 months assessed by RECIST
研究概览
简要总结
The aim of this study is to assess the potential benefit of the addition of immunotherapy with VGX-3100 and INO-9012 (i.e. INO-3112) to concomitant CRT or, to concomitant CRT and continued as adjuvant in patients with locally advanced cervical cancer.
Safety run-in: To test the safety of CRT combined with immunotherapy with INO-3112. This safety run-in phase will include the first 3 patients treated in each of the two INO-3112 combination arms who are exposed to at least two immunotherapy doses and evaluate whether the combination does not pose undue immediate risks to the patients further enrolled in the trial.
Phase II:To demonstrate sufficient activity in the experimental combination arms to warrant a further phase III conclusive trial based on progression free survival (PFS) at 18 months assessed by RECIST by the local investigator. The efficacy will be assessed within each experimental arm while the standard arm will serve as a reference arm to check the reliability of the results.
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
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A: Immunotherapy during and after CRT + vaccine boost
INO-3112 dosing during chemoradiotherapy plus immunotherapy dosing after chemoradiotherapy in an adjuvant setting and vaccine boost one year after last vaccine dosing.
干预措施: INO-3112 vaccine (Biological)
Arm A: Immunotherapy during and after CRT + vaccine boost
INO-3112 dosing during chemoradiotherapy plus immunotherapy dosing after chemoradiotherapy in an adjuvant setting and vaccine boost one year after last vaccine dosing.
干预措施: Radiotherapy (Extrernal beam radiotherapy + brachytherapy) (Radiation)
Arm A: Immunotherapy during and after CRT + vaccine boost
INO-3112 dosing during chemoradiotherapy plus immunotherapy dosing after chemoradiotherapy in an adjuvant setting and vaccine boost one year after last vaccine dosing.
干预措施: Cisplatin chemotherapy (Drug)
Arm B: Immunotherapy during CRT + vaccine boost
INO-3112 dosing during chemoradiotherapy, and vaccine boost one year after last vaccine dosing.
干预措施: INO-3112 vaccine (Biological)
Arm B: Immunotherapy during CRT + vaccine boost
INO-3112 dosing during chemoradiotherapy, and vaccine boost one year after last vaccine dosing.
干预措施: Radiotherapy (Extrernal beam radiotherapy + brachytherapy) (Radiation)
Arm B: Immunotherapy during CRT + vaccine boost
INO-3112 dosing during chemoradiotherapy, and vaccine boost one year after last vaccine dosing.
干预措施: Cisplatin chemotherapy (Drug)
CRT without immunotherapy
Standard chemoradiotherapy without immunotherapy
干预措施: Radiotherapy (Extrernal beam radiotherapy + brachytherapy) (Radiation)
CRT without immunotherapy
Standard chemoradiotherapy without immunotherapy
干预措施: Cisplatin chemotherapy (Drug)
结局指标
主要结局
Progression free survival (PFS) at 18 months assessed by RECIST
时间窗: 18 months
Progression Free Survival at 18 months assessed by local investigator
Occurence of Adverse Events
时间窗: 6 months
In order to ensure adequate safety of the combination treatment, a safety run-in will be performed. This safety run-in phase will include the first 3 patients treated in each of the experimental arms (arms A \& B) exposed to at least two immunotherapy doses. The acute safety of the combination of INO-3112 with concomitant CRT will be evaluated similar to a phase I "3+3" safety design. The safety evaluation will be done by the Data Safety Monitoring Board who will invoke an IDMC evaluation of the whole study if undue safety signals are observed. Acute toxicity is defined as a grade 3 or more related AEs occurring between the first dose of vaccine administration and up to 14 days after the second dose of immunotherapy. Adverse events are graded according to the NCI CTCAE v4.0. Use of narcotics will be reviewed on case-to-case basis by a medical review team to assess its relevance towards the safety evaluation
次要结局
未报告次要终点