A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 Photoimmunotherapy Versus Physician's Choice Standard of Care for the Treatment of Locoregional, Recurrent Head and Neck Squamous Cell Carcinoma in Patients Who Have Failed or Progressed On or After at Least Two Lines of Therapy, of Which at Least One Line Must Be Systemic Therapy
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 135
- 试验地点
- 3
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 vs Physician's Choice Standard of Care for the Treatment of Locoregional, Recurrent Head and Neck Squamous Cell Carcinoma in Patients Who Have Failed or Progressed On or After at Least Two Lines of Therapy
详细描述
The study will have an Experimental Arm and a Control Arm.
Experimental Arm:
Patients may receive repeated ASP-1929 PIT interventions for up to a maximum of 8 cycles within a period of up to 12 months after randomization until the patient has complete remission, progressive disease that is no longer amendable to study treatment, patient experiences intolerable side effects, or patient discontinues study treatment. Repeat ASP-1929 treatment cycles will be administered no less than 4 weeks from the previous ASP-1929 infusion.
Control Arm:
Patients may be treated with physician's choice standard of care until the patient has progressive disease, patient experiences intolerable side effects, discontinues study treatment, or chooses to withdraw.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Have a histologically confirmed locoregional persistent, recurrent or second primary squamous cell carcinoma of the head and neck, not amenable to curative treatment
- •Have failed or progressed on or after at least 2 lines of therapy for squamous cell carcinoma of the head and neck, one of which must be prior systemic platinum-based chemotherapy
- •Have completed prior curative radiation therapy for treatment of their head and neck region
- •Have locoregional head and neck tumor site(s) that are all accessible to light illumination
- •Have target tumors that are clearly measurable by contrast enhanced CT scan, or MRI scan with gadolinium if CT scan is not adequate or the patient has an allergy to CT contrast media.
- •Have a life expectancy of > 6 months, based on Investigator judgment
- •Male participants must agree to use contraception during the treatment period and for at least 6 months after the last ASP-1929 infusion
- •Female patients of childbearing potential must not be pregnant or breastfeeding and agree to follow the contraceptive guidance during the treatment period and for at least 6 months after the last dose of trial intervention and must refrain from breastfeeding for at least 2 months after the last ASP-1929 infusion
- •Have an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
排除标准
- •Have a history of significant (>= Grade 3) cetuximab infusion reactions
- •Have been treated with prior systematic chemotherapy or targeted small molecule therapy or radiation therapy within 2 weeks of trial Day 1 or not recovered from adverse events due to a previously administered agent
- •Have been treated with an anticancer monoclonal antibody therapy within 4 weeks of trial Day 1 or have not recovered from adverse events due to previously administered agent
- •Have been treated with an investigational agent or intervention within 4 weeks of trial Day 1 or have not recovered from adverse events, due to previously administered agent or intervention
- •Have a present history of distant metastatic disease (M1)
- •Have an active undergoing treatment or have a diagnosis of an active cancer other than nonmelanoma skin cancer or HNSCC
- •Have a tumor in enhanced CT or MRI scan invading a major blood vessel, unless the vessel has been embolized, stented or surgically ligated to prevent potential bleeding from a blood vessel
- •Have impaired hepatic function
- •Have impaired renal function
- •Have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with trial requirements
- •Have been previously treated or randomized to any trial using ASP-1929 or RM-1929 PIT as the study treatment
研究组 & 干预措施
ASP-1929 Photoimmunotherapy
Use of ASP-1929 Photoimmunotherapy
干预措施: ASP-1929 Photoimmunotherapy (Combination Product)
Physician's Choice SOC
docetaxel, cetuximab, methotrexate, paclitaxel
干预措施: Physician's Choice SOC (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: 24 months
PFS, defined as the time from randomization to the first occurrence of disease progression (PD), as determined by the Central Radiographic Review according to RECIST 1.1 with modifications, or death from any cause, whichever occurs first.
Overall Survival (OS)
时间窗: 24 months
OS, defined by the time interval between the patient randomization and death due to any cause.
次要结局
- Objective Response Rate (ORR)(24 months)
- Duration of Response (DoR)(24 months)
- Event-Free Survival (EFS)(24 months)
- Eastern Cooperative Oncology Group (ECOG) performance status(24 months)
- Quality of Life (QoL) assessment - EORTC QLQ-C30(24 months)
- Quality of Life (QoL) assessment - EORTC QLQ H&N 35(24 months)
- Quality of Life (QoL) assessment - EQ 5D-5L(24 months)
- Population Pharmacokinetics (PK) of ASP-1929(12 months)
- Presence of Anti-Drug Antibodies (ADA) of ASP-1929(24 months)
- Complete Response (CR)(24 months)
- Complete Response by Biopsy (CRb)(24 months)