EUCTR2021-000872-13-NL进行中（未招募）1 期
Vaccination against cOvid In CancEr - VOICE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 873
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
- •To be eligible to participate in this study, a subject must meet all of the following criteria:
- •Age of 18 years or older
- •Life expectancy > 12 months
- •Ability to provide informed consent
- •Additional criteria for cohort A:
- •Partner of a participating patient
- •Additional criteria for cohort B:
- •Histological diagnosis of a solid malignancy
- •Treatment with monotherapy immune checkpoint inhibitor (ICI) against Programmed Death 1 (PD1) or its ligand PD-L1 (in curative or non-curative setting)
- •Last ICI administration within 3 months of vaccination
- •Additional criteria for cohort C:
- •Histological diagnosis of a solid malignancy
- •Treatment with cytotoxic chemotherapy (monotherapy and combination chemotherapy is allowed, as well as a combination with radiotherapy, in curative or non-curative setting)
- •Last chemotherapy administration within 4 weeks of vaccination
- •Additional criteria for cohort D:
- •Histological diagnosis of a solid malignancy
- •Treatment with a PD1 or PD-L1 antibody in combination with cytotoxic chemotherapy (in curative or non-curative setting)
- •Last chemotherapy administration within 4 weeks of vaccination
- •Last ICI administration within 3 months of vaccination
- •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 436
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 435
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Confirmed SARS-CoV-2 infection (current or previous)
- •Women who are pregnant or breastfeeding
- •Active hematologic malignancy
- •Any immune deficiency not related to cancer or cancer treatment (e.g. inherited immune deficiency or known infection with Human Immunodeficiency Virus)
- •Systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medication within 14 days of vaccination. Inhaled or topical steroids, and adrenal replacement steroids (> 10 mg daily prednisone equivalent) are permitted. In addition, standard of care with short course steroids to prevent nausea and allergic reactions from chemotherapy or iodinated CT contrast is allowed.
- •Additional criteria for cohort A:
- •Current or previous diagnosis of a solid malignancy, unless treated with curative intent >5 years before enrolment and without signs of recurrence during proper follow-up
- •Previous history of a hematologic malignancy
- •Additional criteria for cohort B:
- •Treatment with cytotoxic chemotherapy within 4 weeks of vaccination
- •Additional criteria for cohort C:
- •Treatment with an ICI within 3 months of vaccination