Neoadjuvant Radiation and Evorpacept (ALX148) in Combination With Pembrolizumab In Patients With Previously Untreated Locally Advanced, Resectable, HPVOPC (Human Papilloma Virus Oropharynx Cancer)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 28
- 试验地点
- 6
- 主要终点
- Pathologic complete response
研究概览
简要总结
The majority of head and neck cancer patients do not respond to immunotherapies, and clinical responses are often not durable. However, targeting tumors with stereotactic radiation in combination with immunotherapy while sparing draining lymphatics enhances anticancer immunity, resulting in dramatic response in HPV (Human Papilloma Virus) virus related cancers of the throat. This trial will leverage targeted tumor radiation and immunotherapy in advance of standard surgical therapy to improve the response of HPV (Human Papilloma Virus) throat cancer to radiation and immunotherapy.
详细描述
This is a prospective, multi-center, open-label, one-arm, two-stage, Phase II study to evaluate the efficacy of neoadjuvant immunoradiotherapy (NIRT) in patients with stage I HPVOPC (Human Papilloma Virus Oropharynx Cancer) amenable to surgical resection, including AJCC (American Joint Committee on Cancer) VIII T1-2N1M0 HPVOPC (Human Papilloma Virus Oropharynx Cancer) and excluding patients with solitary lymph nodes less than 3 cm. A Simon's two-stage optimal design is used for this study. We will test the hypothesis that neoadjuvant stereotactic tumor targeting radiation along with CD47 inhibition (evorpacept) and PD-1 inhibition (pembrolizumab) provides pathologic response compared to current standard of care rates of locoregional control.
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
- •Histologically confirmed diagnosis of Stage I T1-2N1M0 HPVOPC (Human Papilloma Virus Oropharynx Cancer)
- •Amenable to surgical resection
- •Are able to safely receive neoadjuvant radiation and Evorpacept/Pembrolizumab
排除标准
- •Patients with solitary lymph nodes less than 3 cm
研究组 & 干预措施
Treatment
Stereotactic radiation therapy (SBRT (8GyX3)) will be delivered to gross tumor volume (GTV) +3mm, followed by Pembrolizumab 200 mg IV and Evorpacept 45 mg/kg IV every three weeks x 2 cycles followed by surgical resection of primary tumor and neck dissection.
干预措施: Evorpacept (Drug)
结局指标
主要结局
Pathologic complete response
时间窗: week 7-10
Pathologic response is determined when surgery is performed at week 7-10 of study
Major pathologic response
时间窗: week 7-10
Major pathologic response is defined as \<10% viable tumor cells in the resection specimen) after surgical resection
次要结局
- clinical response(week 7)
- clinical to pathologic down-staging(week 7-10)
- disease free survival(3 years)
- Patient-reported quality of life and functional outcomes (score 20-100 with 100 being best possible score)(post treatment at 7, 11 weeks and at 3 and 12 months)
- Observer-reported quality of life and functional outcomes(post treatment at 7, 11 weeks and at 3 and 12 months)
- overall survival(3 years)
- Patient-reported quality of life and functional outcomes (score 0-100 with 100 being best possible score)(post treatment at 7, 11 weeks and at 3 and 12 months)
- Immune Correlates (T-cell infiltration)(7-11 weeks)
- Safety and toxicity(11 months to three years)
- Immune Correlates (shared tumor and sentinel node T-cell clones)(7-11 weeks)
- Immune Correlates (B-cell germinal centers)(7-11 weeks)
研究者
Joseph Califano
Professor, Department of Otolaryngology-Head and Neck Surgery
University of California, San Diego