NCT05027633招募中2 期
Immunotherapy With Chemotherapy and Chemoradiation for Advanced Squamous Cancer of Nasal Cavity / Paranasal Sinuses (I-NAPA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- To increase overall response rate (ORR)
研究概览
简要总结
This is a single arm phase II study that will evaluate the combination of pembrolizumab, docetaxel, and cisplatin or carboplatin (PDC) as single treatment modality in patients with stage II-IVb (T2-4, any N, M0) squamous cell carcinoma of the nasal cavity/paranasal sinuses (PNS SCC).
详细描述
Primary Objective
-Increase overall response rate (ORR), following pembrolizumab combined with induction chemotherapy prior to radiation, from historical 60% with induction chemotherapy alone to 80%.
Secondary Objective
- Improve the following efficacy endpoints relative to historical results with chemotherapy alone: progression free survival (PFS), overall survival (OS), organ [orbital, maxillary, cranial] preservation rate (OPR), and locoregional failure (LRF).
- To determine safety and tolerability of pembrolizumab combined with induction chemotherapy and chemoradiation in patients with PNS SCC.
- Correlate immune phenotype in tumors and blood, including T cell infiltration and PD-L1 status, with treatment outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 否
入选标准
- •Male/female participants who are at least 18 years of age on the day of signing informed consent with newly diagnosed, previously untreated, histologically and/or cytologically confirmed diagnosis of Stage II-IVb PNS SCC will be enrolled in this study.
- •Male participants:
- •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 150 days after the last dose of study treatment and refrain from donating sperm during this period.
- •Female participants:
- •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:
- •Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR
- •A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 150 days after the last dose of study treatment.
- •The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- •Have measurable disease based on RECIST 1.
- •Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Have adequate organ function as defined in the following table (Table 1). Blood must be collected within 14 days prior to the start of study treatment.
排除标准
- •A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- •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).
- •Patients must not have received prior systemic anti-cancer therapy including investigational agents or radiation therapy for PNS SCC but could have received treatment for prior cancers if greater than 2 years (refer to Item 8 for further details).
研究组 & 干预措施
pembrolizumab, docetaxel, and cisplatin or carboplatin
Other
IV
干预措施: Pembrolizumab (Drug)
pembrolizumab, docetaxel, and cisplatin or carboplatin
Other
IV
干预措施: Docetaxel (Drug)
pembrolizumab, docetaxel, and cisplatin or carboplatin
Other
IV
干预措施: Cisplatin (Drug)
pembrolizumab, docetaxel, and cisplatin or carboplatin
Other
IV
干预措施: Carboplatin (Drug)
结局指标
主要结局
To increase overall response rate (ORR)
时间窗: through study completion, an average of 1 year
次要结局
- To improve the following efficacy endpoints relative to historical results with chemotherapy alone(through study completion, an average of 1 year)
- To determine the safety of pembrolizumab combined with induction chemotherapy and chemoradiation in patients with PNS SCC(through study completion, an average of 1 year)
- To determine the tolerability of pembrolizumab combined with induction chemotherapy and chemoradiation in patients with PNS SCC(through study completion, an average of 1 year)
研究者
研究点 (1)
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