EUCTR2021-003166-12-NL进行中（未招募）1 期
A Phase II Trial of Personalized Tumor Neoantigen Based Vaccine FRAME-001 for Advanced Non-Small Cell Lung Cancer - FRAME-001
Frame Pharmaceuticals B.V.0 个研究点目标入组 15 人开始时间: 2022年1月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
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
- •-Age =18 years.
- •-Eastern Cooperative Oncology Group (ECOG) performance status = 1
- •--Pathologically and radiologically confirmed advanced squamous or non-squamous NSCLC with SD after four cycles of treatment with pembrolizumab as monotherapy or in combination with chemotherapy (carboplatin/cisplatin and pemetrexed/paclitaxel) and suitable for maintenance treatment with pembrolizumab monotherapy.
- •-Patient Framome identification with demonstrated frameshift mutations (Frames) completed as part of molecular pre-screening:
- •oPresence of at least 3 expressed frameshift mutations;
- •oA combined length of ?100 amino acids for the neopeptides resulting from the frameshifts, with preferably more than 100 amino acids.
- •oNo mutations/genetic aberrations in genes relevant for MHC presentation (e.g., beta-2-microglobulin, human leukocyte antigen [HLA] genes).
- •-An expected survival of at least 3 months.
- •-Presence of tumor lesion(s) suitable for biopsy and radiological assessment as per RECIST v1.1 criteria.
- •-Adequate renal function as defined by creatinine clearance > 40 mL/min based on the Cockroft-Gault glomerular filtration rate (GFR).
- •-Adequate hepatic function as evidenced by:
- •oSerum total bilirubin = 2.5 × upper limit of normal (ULN) unless considered due to hepatic metastases.
- •oAspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) = 3.0 × ULN, unless considered due to hepatic metastases.
- •-Ability to return to the hospital for adequate follow-up as required by this protocol.
- •-For all women of childbearing potential (defined as < 2 years after last menstruation or not surgically sterile) must have a negative highly sensitive pregnancy test at screening (serum/urine) and agree to use highly effective method of contraconception according to European Union (EU) Clinical Trial Facilitation Group guidance from time of signing informed consent form until at least 120 days after the last administration of FRAME-001. The partners of participants of childbearing potential must also apply contraceptive methods and are recommended not to donate sperm.
- •-Written informed consent according to International Conference on Harmonisation (ICH)-Good Clinical Practice (GCP).
- •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 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •-Any active infection that according to investigator might interfere with FRAME-001 vaccination.
- •-Patients planned or foreseen to receive systemic immunosuppressive treatment including corticosteroids during the trial are not eligible.
- •-Use of systemic corticosteroids (or other immunosuppressive agents; >10mg daily prednisone equivalent). Inhaled, intranasal or topical and physiological replacement doses of up to 10 mg daily prednisone equivalent are permitted.
- •-Live vaccine within 30 days prior to first dose of FRAME-001.
- •-Concomitant participation in another clinical intervention trial (except participation in a
- •biobank study).
- •-Pregnant or lactating women.
- •-Known allergy to any of the ingredients of the vaccine (i.e., synthetic long peptides, Montanide ISA 51 VG).
- •-Any medical or psychological condition deemed by the Investigator to be likely to interfere with a patient’s ability to give informed consent or participate in the study.
- •-Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- •-Patients with a currently active second malignancy. However, patients with the following history/concurrent conditions are allowed:
- •oBasal or squamous cell carcinoma of the skin;
- •oCarcinoma in situ of the cervix;
- •oCarcinoma in situ of the breast;
- •oIncidental histologic finding of prostate cancer.
研究者
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