NL-OMON51740招募中不适用
POINTING: Towards patient-tailored cancer immunotherapy supported by a multifaceted predictive signature composed of integrative omics and molecular imaging. - POINTING
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
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
- •1. Histologically or cytological documented locally advanced or metastatic
- •NSCLC or melanoma.
- •2. Patients must be eligible for standard treatment with immune checkpoint
- •inhibitor antibody treatment (monotherapy or in combination with other
- •anti-cancer treatments).
- •3. Age >=18 years.
- •4. Measurable disease, as defined by standard RECIST v1.1. Previously
- •irradiated lesions should not be counted as target lesions.
- •5. Metastatic or locally advanced lesion(s) of which a histological biopsy can
- •safely be obtained according to standard clinical care procedures
- •6. Ability to comply with protocol.
- •7. Signed Informed Consent Form.
排除标准
- •1. Malignancies other than melanoma or NSCLC within 5 years prior to inclusion,
- •with the exception of those with a negligible risk of metastasis or death,
- •treated with expected curative outcome (such as adequately treated carcinoma in
- •situ of the cervix, basal or squamous cell skin cancer, localized prostate
- •cancer treated with curative intent or ductal carcinoma in situ treated
- •surgically with curative intent).
- •2. Treatment with systemic immunosuppressive medications (including but not
- •limited to prednisone, cyclophosphamide, azathioprine, methotrexate,
- •thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to
- •study inclusion.
- •Patients who have received acute, low-dose, systemic immunosuppressant
- •medications may be enrolled.
- •The use of inhaled corticosteroids for chronic obstructive pulmonary disease,
- •mineralocorticoids (e.g. fludrocortisone) for patients with orthostatic
- •hypotension, and low-dose supplemental corticosteroids for adrenocortical
- •insufficiency are allowed.
- •3. Signs or symptoms of infection within 2 weeks prior to ZED88082A/CED88004S
- •4. Pregnant or lactating women.
- •5. History of severe allergic, anaphylactic, or other hypersensitivity
- •reactions to chimeric or humanized antibodies or fusion proteins
- •6. Any other diseases, metabolic dysfunction, physical examination finding, or
- •clinical laboratory finding giving reasonable suspicion of a disease or
- •condition that contraindicates the use of ZED88082A/CED88004S, or that may
- •affect the interpretation of the results or render the patient at high risk
- •from complications.
研究者
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