Vaccination Against cOvid In CancEr
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 791
- 试验地点
- 4
- 主要终点
- Immune response to vaccination against COVID-19 measured as antibody response expressed as geometric mean concentration: arbitrary units (AU)/ml
研究概览
简要总结
This study will collect information on immune response and adverse events after vaccination against coronavirus disease (COVID-19) in a vulnerable patient cohort. Understanding the ability or disability to mount a protective immune response after vaccination will help to counsel patients during the pandemic and support decisions on whom to vaccinate and to identify patients who require other measures to protect them from COVID-19.
详细描述
Rationale:
Patients with cancer have an increased risk of adverse outcome of COVID-19, which is determined by their underlying disease and/or cancer treatment. Therefore, vaccination of cancer patients against COVID-19 is recommended. However, phase III studies do not provide robust information on efficacy and safety in this vulnerable population. In patients with cancer, the disease itself, but also immunotherapy and chemotherapy, may have a significant impact on the ability to develop an effective immune response to COVID-19 vaccination, and could even increase the risk of adverse events.
Objective:
To assess immune response and adverse events after administration of one approved vaccine against COVID-19 in patients with cancer treated with immunotherapy and/or chemotherapy.
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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
- •Exclusion criteria:
- •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
排除标准
- 未提供
结局指标
主要结局
Immune response to vaccination against COVID-19 measured as antibody response expressed as geometric mean concentration: arbitrary units (AU)/ml
时间窗: Measured at 28 days after vaccination
The primary endpoint is the antibody based immune response to vaccination against COVID-19 on day 28 after the second vaccination in patients receiving cancer treatment as compared to individuals without cancer. Expressed as antibody response expressed as geometric mean concentration: arbitrary units (AU)/ml
次要结局
- Assessment of immune response: measured as levels of SARS-CoV-2 specific T-cell responses expressed as number of IFNg producing T cells/ million peripheral blood mononuclear cells (PBMCs)(measured 28 days to 18 months after vaccination)
- Safety assessment (S)AEs; Incidence and severity of solicited AEs during 7 days after each vaccination with incidence and nature of SAEs reported during 7 days after each vaccination(During 7 days after vaccination)
- Assessment of immune response: expressed as geometric mean antibody concentration: arbitrary units (AU)/ml(measured at 6 to 18 months after vaccination)
- Safety assessment AE of special interest (SI)s with Incidence, nature and severity of AESIs graded according to CTCAE v5.0 reported up to 12 months after vaccination(From start till 12 months after vaccination)
- Safety assessment immune related (ir), with incidence and nature of newly occurring irAEs grade ≥ 3 in cohort B and D reported up to 28 days(From start till 28 days after second vaccination)