A Multicenter Phase II Trial of Intratumoral pIL-12 Electroporation in Treatment-Refractory Metastatic and Unresectable SCC of the Head and Neck
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 4
- 主要终点
- Best Overall Response Rate (BORR) by RECIST v1.1
研究概览
简要总结
This study will assess the safety and effectiveness of ImmunoPulse IL-12® in treatment-refractory metastatic and unresectable squamous cell carcinoma of the head and neck (HNSCC). ImmunPulseIL12® is the combination of intrtumoral interleukin-12 gene (also known as tavokinogene telseplasmid [tavo]) and in vivo electroporation-mediated plasmid deoxyribonucleic acid [DNA] vaccine therapy (tavo-EP) administered using the OncoSec Medical System (OMS). Intratumoral tavo is a gene therapy approach to directly induce a pro-inflammatory response within a tumor to initiate and/or enhance anti-tumor immunity.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological diagnosis of squamous cell carcinoma (SCC) of head and neck with American Joint Committee on Cancer (AJCC) Stage III, IVA or IVB and not amenable to surgical resection or locoregional radiation therapy with curative intent.
- •Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- •Patients must have at least one tumor accessible for intratumoral injection and EP on investigator's assessment.
- •Patients must have at least one additional lesion (measurable by RECIST v1.1 or non-target) identified as a control untreated lesion to be left untreated and followed for response.
- •Patients may have had prior chemotherapy or immunotherapy or radiation therapy. Any drug-related adverse events (AEs) identified during prior therapy must have been well-controlled (typically resolution to ≤ Grade 2), or resolved upon investigator review prior to initiation of the study therapy.
- •Patients must have platinum-refractory disease defined as disease progression within 12 months platinum-based chemoradiation with curative intent or any disease progression on platinum-based chemotherapy in the absence of radiation.
- •Age ≥ 18 years old.
- •Patients must have agreed to a new biopsy of tumor (deemed accessible and safe for biopsy by the investigator's assessment) and allowing acquired tissue to be used for biomarker analysis. If the biopsied lesions were previously irradiated, they must demonstrate either radiographic or pathological evidence of recurrent or residual disease.
- •No systemic antineoplastic therapy may have been received between the time of biopsy and the first administration of study treatment.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Life expectancy of at least 3 months.
- •Adequate organ function.
- •Female patient of childbearing potential has a negative pregnancy test within 14 days prior to the start of study drug.
- •Women of child-bearing potential and men must agree to use adequate contraception.
- •Able to give informed consent.
排除标准
- •Prior therapy with IL-12 or prior gene therapy.
- •Concurrent ongoing administration of systemic therapy (e.g. chemotherapy), or radiation therapy.
- •Evidence of significant active infection (e.g., pneumonia, cellulitis, wound abscess, etc.) at time of study entry.
- •Pregnant or breast-feeding women are excluded.
- •Patients with electronic pacemakers or defibrillators are excluded.
- •Significant disease or uncontrolled disease, i.e. cardiovascular renal, hepatic, endocrine, metabolic, neurologic; or other significant disease that would limit the patients ability to participate in the study as determined by the investigator or medical monitor.
结局指标
主要结局
Best Overall Response Rate (BORR) by RECIST v1.1
时间窗: Every 6 weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months)
BORR is defined as the percentage of participants with evaluable lesions that achieved a complete response (CR) or partial response (PR) as assessed by the investigator using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.
次要结局
- Median Progression Free Survival (PFS)(From start of study treatment weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months))
- Median Overall Survival (OS)(From the start of study treatment until death)
- Best Overall Response Rate (BORR) by Immune-related Response Criteria (irRC)(Every 6 weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months))
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(From first study treatment to 30 days after the last study treatment (up to 14.5 months))
- Regression Rate of Treated and Untreated Lesions(Every 6 weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months))
- Median Time to Progression (TTP)(From start of study treatment weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months))