NL-OMON49728招募中不适用
A phase 1-2 immunoPET imaging study with ZED88082A in patients before and during treatment with 1) MPDL3280A or 2) PD-1 antibody plus or minus ipilimumab - CD8 PET imaging study before and during immunotherapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subjects with histologically confirmed locally advanced or metastatic cancer
- •for the following tumor types
- •* Cancer types other than melanoma; subjects meeting the eligibility criteria
- •as formulated in the MPDL3280A treatment study protocol
- •(MPDL3280A-treatment-IST-UMCG) are eligible for part A or part B1.
- •* Melanoma; subjects eligible to receive standard of care anti-PD1 therapy plus
- •or minus ipilimumab, are eligible for part B2.
- •2. Tumor lesion(s) of which a histological biopsy can safely be obtained
- •according to standard clinical care procedures.
- •3. Measurable disease, as defined by standard RECIST v1.1. Previously
- •irradiated lesions should not be counted as target lesions.
- •4. Signed informed consent.
- •5. Age >=18 at the time of signing informed consent.
- •6. Life expectancy >=12 weeks.
- •7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •8. Ability to comply with the protocol.
- •9. For female patients of childbearing potential and male patients with
- •partners of childbearing potential, agreement (by patient and/or partner) to
- •use a highly effective form(s) of contraception (i.e., one that results in a
- •low failure rate [< 1% per year] when used consistently and correctly).
排除标准
- •1. Potential subjects with cancer other than melanoma will be excluded from
- •participation in this study if they meet exclusion criteria formulated in the
- •MPDL3280A treatment study protocol (MPDL3280A-treatment-IST-UMCG).
- •2. Signs or symptoms of infection within 2 weeks prior to ZED88082A/CED88004S
- •3. Prior immune checkpoint inhibitor treatment, including but not limited to
- •anti-PD1 and anti-PD-L1 therapeutic antibodies.
- •4. History of severe allergic, anaphylactic, or other hypersensitivity
- •reactions to chimeric or humanized antibodies or fusion proteins
- •5. 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.
- •6. Pregnant or lactating women.
研究者
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