A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 Photoimmunotherapy Versus Physicians 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

Arron Sarah0 个研究点目标入组 275 人开始时间: 2020年12月7日最近更新: 2023年10月17日

适应症

试验速览

阶段: 4 期
状态: 招募中
发起方
入组人数: 275

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 18age old 至 ot applicable（—）
性别: All

入选标准

•Patients must meet the following criteria to be eligible for study participation:
•1. Patients with histologically confirmed locoregional persistent, recurrent or second primary squamous cell carcinoma of the head and neck, not amenable to curative treatment, including surgery, radiation, or platinum chemotherapy per treatment guidelines.
•2. Patient must 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 for treatment of their primary or recurrent head and neck cancer, unless in the opinion of the medical oncologist, the use of platinum-based chemotherapy is contraindicated or not recommended. Patients who are unable to receive systemic platinum-based chemotherapy should receive an appropriate alternative standard of care systemic therapy for their treatment instead of platinum-based chemotherapy.
•3. Patients must have completed prior curative radiation therapy for treatment of their head and neck region.
•4. All locoregional head and neck tumor site(s) are accessible for light illumination.
•5. Target tumors are clearly measurable by contrast enhanced CT scan (or MRI with gadolinium if CT scan is not adequate or the patient has an allergy to CT contrast media).
•6. Life expectancy > 6 months based on Investigator judgement.
•7. Male or female patients at least 18 years old.
•8. Patients must have an ECOG score of 0 to 1.

排除标准

•Patients with any of the following will be excluded from participation in the study:
•1. Patients with a history of significant (Grade 3 or greater) cetuximab infusion reactions.
•2. Patients who have been treated with prior systemic chemotherapy or targeted small molecule therapy or radiation therapy within 2 weeks of trial Day 1 or who have not recovered from adverse events, due to previously administered agent.
•3. Patients who have been treated with an anticancer monoclonal antibody therapy within 4 weeks of trial Day 1 or who have not recovered, from adverse events due to the previously administered agent.
•4. Patients who have been treated with an investigational agent or intervention within 4 weeks of trial Day 1 or who have not recovered from adverse events, due to previously administered agent or intervention.
•5. Present history of distant metastatic disease (M1).
•6. Patients who are actively undergoing treatment of or have a diagnosis of an active cancer other than nonmelanoma skin cancer or HNSCC.
•7. Tumor in enhanced CT or MRI scan invading a major blood vessel (such as the carotid artery) unless the vessel has been embolized, stented, or surgically ligated to prevent potential bleeding from a blood vessel (hemorrhage) as confirmed by central radiology review before randomization.
•8. Patients with a hemoglobin < 9.0g/dL, WBC < 2000/uL, and platlets < 100 x10^3/uL.
•9. Patients with impaired hepatic function.
•10. Patients with impairment of renal function.
•11. Uncontrolled intercurrent illness.
•12. Patient requires examinations or treatments within 4 weeks after ASP-1929 administration where they would be exposed to significant light unrelated to the study treatment.
•13. Patients who have been previously treated or randomized to any trial using ASP-1929 or RM-1929 as the study treatment.

研究者

发起方

Arron Sarah

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