NL-OMON49932撤回2 期
A Phase II Trial of Personalized Tumor Neoantigen Based Vaccine FRAME-001 for Advanced Non-Small Cell Lung Cancer - FRAME-001 personalized vaccine in NSCLC
Frame Pharmaceuticals B.V.0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 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
入排标准
- 年龄范围
- 18 至 99（—）
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:
- •o Presence of at least 3 expressed frameshift mutations;
- •o A combined length of *100 amino acids for the neopeptides resulting from the
- •frameshifts, with preferably more than 100 amino acids.
- •o No 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:
- •o Serum total bilirubin * 2.5 × upper limit of normal (ULN) unless considered
- •due to hepatic metastases.
- •o Aspartate 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
- •- 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).
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:
- •o Basal or squamous cell carcinoma of the skin;
- •o Carcinoma in situ of the cervix;
- •o Carcinoma in situ of the breast;
- •o Incidental histologic finding of prostate cancer.
研究者
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