2023-505917-25-00招募中2 期
Neoadjuvant pembrolizumab plus chemotherapy in locally advanced sinonasal carcinoma (NeoPeSino)
Istituti Clinici Scientifici Maugeri In Forma Abbreviata Istituti Clinici Scientifici Maugeri O Anche Ics Maugeri O Maugeri S.p.A. Sb2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2023年10月27日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Neoadjuvant therapy objective response rate (ORR, defined as the sum of complete remission (CRs) and partial responses (PRs) by RECIST v. 1.1 criteria will serve as the primary efficacy endpoint.
研究概览
简要总结
Safety and activity of pembrolizumab plus chemotherapy as neoadjuvant treatment in locally advanced SNUC.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Have centrally histologically-confirmed, treatment-naïve SNUC that is considered curable by local therapies. Resectability at diagnosis should be recorded on the electronic case report form (eCRF) but is not a required inclusion criteria.
- •Have locally advanced disease defined as stage III of IVa-b according to AJCC cancer staging system VIII edition.
- •Be willing and able to provide written informed consent for the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
- •Be ≥ 18 years of age on day of signing informed consent.
- •Have measurable disease based on RECIST 1.1 as determined by the site.
- •Have a performance status of 0 or 1 on the ECOG Performance Scale.
- •Demonstrate adequate organ function as defined in Table 4, all screening labs should be performed within 15 days of treatment initiation.
- •A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 180 days, corresponding to time needed to eliminate any study treatments plus an additional 90 days (a spermatogenesis cycle) for study treatments with evidence of genotoxicity at any dose after the last dose of study treatment and refrain from donating sperm during this period.
- •A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies: a. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR b. A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 180 days (corresponding to time needed to eliminate any study treatments plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity after the last dose of study treatment..
- •Have provided tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred.
- •Have locally advanced disease defined as stage III of IVa-b according to AJCC cancer staging system VIII edition.
- •Have measurable disease based on RECIST 1.1 as determined by the site.
- •Have a performance status of 0 or 1 on the ECOG Performance Scale.
排除标准
- •Has disease that is deemed not suitable for local therapy administered with curative intent (e.g. severe brain involvement).
- •Have metastatic disease defined as stage IVc according to AJCC cancer staging system VIII edition.
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
- •Has received prior systemic anti-cancer therapy including investigational agents prior to allocation.
结局指标
主要结局
Neoadjuvant therapy objective response rate (ORR, defined as the sum of complete remission (CRs) and partial responses (PRs) by RECIST v. 1.1 criteria will serve as the primary efficacy endpoint.
Neoadjuvant therapy objective response rate (ORR, defined as the sum of complete remission (CRs) and partial responses (PRs) by RECIST v. 1.1 criteria will serve as the primary efficacy endpoint.
次要结局
未报告次要终点
研究者
Laura Deborah Locati
Scientific
Istituti Clinici Scientifici Maugeri In Forma Abbreviata Istituti Clinici Scientifici Maugeri O Anche Ics Maugeri O Maugeri S.p.A. Sb
研究点 (2)
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