A Phase II, Multi-center, Single Arm Trial of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Locally Advanced and/or Metastatic Anorectal Squamous Cell Carcinoma (ASCC) After Progression on First Line Chemotherapy.
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
- Objective response rate (ORR)
研究概览
简要总结
The purpose of this study is to gather information on the safety and effectiveness of lenvatinib combined with pembrolizumab in anal/rectal cancer that has spread to other parts of the body and will not respond to standard care.
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
- •Histological confirmation of anorectal squamous cell carcinoma per the American Joint Committee on Cancer 8th edition. NOTE: If archived tissue is not available for diagnostic histological confirmation [core, incisional, or excisional], a new biopsy of a tumor lesion prior to tumor irradiation should be obtained.
- •Unresectable locally advanced or metastatic anorectal squamous cell carcinoma following progression on first line chemotherapy or chemoradiation therapy. Prior use of immunotherapy with Retifanlimab is allowed but not mandatory.
- •Prior chemoradiation therapy with either definitive intent or palliative intent is allowed.
- •Measurable disease based on Response Evaluation Criteria In Solid Tumors 1.1 Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions within 28 days prior to registration.
排除标准
- •Has received prior therapy with an anti-PD-1, anti- PDL1, 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) with the exception of Retifanlimab immunotherapy.
- •Prior significant immunotherapy related adverse events requiring permanent discontinuation of the immunotherapy agents including events like pneumonitis, myocarditis, renal failure, Guillain Barre syndrome or myasthenia gravis.
- •Active autoimmune disease with ongoing treatment with chronic immunosuppressive therapy such as DMARDs .
研究组 & 干预措施
Treatment arm
Treatment consists of lenvatinib (20 mg orally once daily) in combination with pembrolizumab (200 mg IV every 3 weeks).
Pembrolizumab will be given for a maximum of 2 years (total 35 cycles) with dosing every 3 weeks.
干预措施: Lenvatinib (Drug)
Treatment arm
Treatment consists of lenvatinib (20 mg orally once daily) in combination with pembrolizumab (200 mg IV every 3 weeks).
Pembrolizumab will be given for a maximum of 2 years (total 35 cycles) with dosing every 3 weeks.
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: End of treatment up to 2 years
Number of participants who achieve a complete or partial response based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
次要结局
- Disease control rate (DCR)(End of treatment up to 2 years)
- Progression free survival (PFS)(2 years after end of treatment)
- Overall survival (OS)(2 years after end of treatment)
- Treatment Percentage(End of treatment up to 2 years)