EUCTR2019-002328-33-BE进行中（未招募）1 期
A Multi-Centre, Open-label Phase 2a Trial of the Combination of VB10.16 and Atezolizumab in Patients with Advanced or Recurrent, Non-resectable HPV16-Positive Cervical Cancer
ykode Therapeutics ASA0 个研究点目标入组 50 人开始时间: 2019年9月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- Female
入选标准
- •1. Has persistent, recurrent, or metastatic non-resectable squamous cell carcinoma, adeno-squamous carcinoma, or adenocarcinoma of the cervix, who has failed or is not eligible for treatment with systemic chemotherapy, radiotherapy or other standard-of-care anticancer treatment.
- •2. Tumour must be HPV16 positive = as determined by central laboratory. Provision of an archival tumour tissue sample not older than 2 years or new biopsy for analysing HPV16 status is mandatory.
- •3. Must have a biopsy (archived or new) available for PD-L1 assessment at Screening. Provision of an archival tumour tissue sample not older than 2 years or new biopsy for analysing PD-L1 status is mandatory.
- •4. Has measurable disease as assessed by the local site investigator/radiology as per RECIST 1.1.
- •5. Has recovered from the effects of surgery, radiation therapy, or chemoradiotherapy. At least 6 weeks must have elapsed from the last administration of chemoradiotherapy to Visit 1, and at least 3 weeks must have elapsed from the last administration of radiation therapy alone, and at least 4 weeks must have elapsed from the last dose of prior
- •systemic anti-cancer therapy and from the time of any major surgical procedure before Visit 1.
- •6. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 at Screening.
- •7. Is aged 18 years or older.
- •8. Has life expectancy of at least 6 months in the best judgement of the investigator.
- •9. Is willing and able to sign a written informed consent form.
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Patients with rapidly progressing disease who have experienced disease progression while on anticancer treatment (or within 3 months from the last dose of this treatment).
- •2. Has brain metastases (unless they have received prior treatment and are controlled and stable for at least 6 weeks before Visit 1) or leptomeningeal spread of disease.
- •3. Has positive serological test for:
- •-hepatitis C virus (HCV) and has not been treated; patients who are HCV-RNA negative would be eligible.
- •- hepatitis B virus (HBV) surface antigen (HBsAg); patients with positive HBV core antibody must have positive surface antibody and negative HBV viral load (HBV DNA) to be eligible.
- •- human immunodeficiency virus (HIV).
- •4. Has other concomitant or prior malignant disease, except for: a) adequately treated basal cell carcinoma or other non-melanomatous skin cancer, or low-grade urothelial cancer; b) other malignancies treated with curative intent, without disease recurrence and in complete remission with treatment completed 2 years or more before Screening study entry (time of providing consent).
- •5. Has an active, known or suspected autoimmune disease including, but not limited to, inflammatory bowel disease, systemic lupus erythematosus, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, vasculitis, glomerulonephritis and multiple sclerosis. Exceptions include: patients with vitiligo; autoimmune-related hypothyroidism on stable dose of hormone replacement; type 1 diabetes; mellitus on an insuline regime; alopecia areata; psoriasis; eczema; and transient autoimmune manifestations of an acute infectious disease that resolved upon treatment of the infectious agent (e.g., acute Lyme arthritis). Exceptions require discussion with the medical monitor).
- •6. Is receiving systemic immunosuppression including systemic steroids or the use of immunosuppressive agents (e.g., cyclosporine, azathioprine, methotrexate or tumour necrosis factor alfa [TNF-a ] blockers) for any concurrent condition. All systemically administered corticosteroids must be discontinued >2 weeks prior to the first study vaccine administration.
- •7. Has known allergy to aminoglycosides (especially kanamycin) or any study treatment component.
- •8. Has history of toxic shock syndrome.
- •Please refer to section 8.2 of the protocol for the full criteria.
研究者
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