EUCTR2020-005910-17-DE进行中（未招募）1 期
Phase 2 multicenter study investigating the tolerability and efficacy of UV1 vaccine in patients with recurrent or metastatic PD-L1 positive (CPS=1) head and neck squamous cell carcinoma planned for first-line treatment with pembrolizumab - FOCUS
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Males and Females at least 18 years of age
- •-Histologically confirmed diagnosis of a non-resectable recurrent or metastatic head and neck squamous cell carcinoma
- •-At least one measurable tumor lesion as per RECIST v1.1, (Scan not older than 4 weeks before randomization)
- •-Eligible for pembrolizumab monotherapy (PD-L1 CPS >/= 1%) and adequate laboratory parameters for pembrolizumab monotherapy as assessed by the investigator
- •-ECOG-performance score 0-2
- •-Written informed consent obtained according to international guidelines and local laws
- •-Ability to understand and give informed consent.
- •-Safe contraception measures for males and females. Procedures with a pearl index of less than 1% apply as safe pregnancy prevention measures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 65
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •-Patients for whom a combination therapy of a checkpoint inhibitor and a chemotherapy is deemed necessary in the opinion of the investigator
- •-Participation in another interventional study simultaneously and within the last 30 days prior to inclusion (registries or observational studies allowed)
- •-Concurrent malignancies other than disease under study within 5 years prior to inclusion, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS > 90%) treated with expected curative outcome
- •-Active, known, or suspected autoimmune disease requiring systemic treatment
- •-Concomitant therapy with systemic immune suppression (use of chronic systemic steroid medication (up to 5 mg/day prednisolone equivalent is allowed; patients using physiological replacement doses of prednisone for adrenal or pituitary insufficiency are eligible)
- •-History of severe autoimmune disorder or history of organ transplant
- •-Any serious or uncontrolled medical disorder or active infection that may increase the risk associated with study participation, study drug administration, or would impair the ability of the subject to receive study drug.
- •-Significant acute or chronic infections including, among others (test not older tan 4 weeks prior to randomization): Any positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS), Any positive test result for hepatitis B virus or hepatitis C virus indicating acute or chronic infection.
- •-Intake of drug products which potentially cause adverse interactions with the medicinal product under investigation
- •-Diseases/medical findings which may have a significant effect on the target variables and thus mask or inhibit the therapeutic effect under investigation
- •-Pregnancy or lactation
- •-(Bacterial) infections requiring systemic antibiotic treatment within 2 weeks prior to first dose of study treatment (depending on group assignment: either prior to first UV1 or prior to first pembrolizumab administration)
- •-History of allergy or hypersensitivity to study drug or any constituent of the products
研究者
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