NL-OMON52037招募中不适用
Vaccination against cOvid In CancEr - VOICE
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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
入排标准
- 年龄范围
- 18 至 99（—）
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
- •An additional criteria for cohort B:
- •Histologic 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
- •Last ICI administration within 3 months of vaccination
- •An additional criteria for cohort C:
- •Histologic 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
- •An additional criteria for cohort D:
- •Histologic 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
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
- •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 steroid > 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 tumor, unless treated with curative
- •intent >5 years before enrolment and with no signs of recurrence during proper
- •Previous history of a hematologic malignancy
- •An additional criteria for cohort B:
- •Treatment with cytotoxic chemotherapy within 4 weeks of vaccination
- •An additional criteria for cohort C:
- •Treatment with an ICI within 3 months of vaccination
研究者
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