NCT06128863进行中（未招募）2 期
Phase II, Single-arm Clinical Trial Evaluating Efficacy and Safety of Pembrolizumab in Combination With a Soluble LAG-3 Protein, Eftilagimod Alpha, and Radiotherapy in Neoadjuvant Treatment of Patients With Soft Tissue Sarcomas (EFTISARC-NEO)
Maria Sklodowska-Curie National Research Institute of Oncology1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年7月17日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pathologic response
研究概览
简要总结
This is a phase II single-arm single-stage study evaluating efficacy and safety of pembrolizumab in combination with a soluble LAG-3 protein, eftilagimod alfa (Efti) and radiotherapy in neoadjuvant treatment of patients with soft tissue sarcomas. This study will determine the pathologic response rate (defined as percentage of tumor hyalinization/fibrosis) to the combination treatment.
详细描述
Systemic therapy with pembrolizumab and eftilagimod alfa and radiotherapy are administered concurrently. Systemic treatment lasts for 9 weeks (study week 1-9). Radiation therapy lasts for 5 weeks (5 days per week) in weeks 2-6. Surgery takes place 5-6 weeks after completion of radiation therapy (week 11-12). Any adjuvant treatment (chemotherapy, immunotherapy, radiation therapy) after surgical treatment is not allowed. Patients will be then followed up regularly for a period of 24 months.
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
- •Primary or locally recurrent deep-seated extremities, girdles and/or superficial trunk (thoracic or abdominal wall) soft tissue sarcoma
- •Grade 2 or 3 tumors according to Fédération Nationale des Centres de Lutte contre le Cancer (FNCLCC);
- •Size of the primary tumor >5 cm at instrumental staging (CT, MRI), or locally recurrent of any size;
- •Measurable disease based on RECIST 1.1;
- •Non-metastatic disease;
排除标准
- •Ewing sarcoma, Alveolar and embryonal rhabdomyosarcoma
- •Previous treatment with eftilagimod alfa, anti-PD-1 or anti-PD-L1;
- •Prior radiotherapy to tumor-involved sites;
研究组 & 干预措施
single arm
Other
Systemic therapy with pembrolizumab and eftilagimod alfa is given concurrently with radiotherapy.
Surgery is scheduled 5-6 weeks after completion of radiotherapy.
干预措施: Pembrolizumab, Eftilagimod alfa (Drug)
结局指标
主要结局
Pathologic response
时间窗: At the time of definitive surgical treatment
The primary efficacy endpoint is a percent tumor hyalinization as a marker of response to treatment assessed at the time of surgical resection.
次要结局
- Number of Participants Experiencing Adverse Events (AEs)(All adverse events will be documented from the enrolment of the first patient until 100 days after the surgical treatment of the last patient (2 years).)
- Distant metastasis-free survival (DMFS)(From the date of curative surgery to the date of first distant metastasis or date of death (whatever the cause), whichever occurs first)
- Overall survival (OS)(From the date of curative surgery up to the date of death or the last date the participant was known to be alive)
- Response rate(From the date of the first dose of treatment to the date of curative surgery)
- Number of participants completing neoadjuvant therapy(2 years)
- Disease-free survival (DFS)(From the date of curative surgery to the date of first recurrence or death (whatever the cause), whichever occurs first)
- Local recurrence-free survival (LRFS)(From the date of curative surgery to the date of first local recurrence or date of death (whatever the cause), whichever occurs first)
研究者
研究点 (1)
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相关资讯
Immutep's Efti Plus Pembrolizumab and Radiotherapy Shows Promise in Soft Tissue Sarcoma- A Phase II trial of eftilagimod alpha (efti) combined with pembrolizumab and radiotherapy demonstrates significant efficacy in neoadjuvant treatment of soft tissue sarcoma.
- The triple combination therapy led to a greater than three-fold increase in tumor hyalinization/fibrosis compared to historical results from radiotherapy alone.
- 71.4% of patients achieved a pathologic response, defined as ≥35% hyalinization/fibrosis, with 9.5% achieving a complete pathologic response in the EFTISARC-NEO trial.
- The triple combination therapy was found to be safe, with no grade ≥3 toxicities related to efti and pembrolizumab reported.last yearImmutep's Efti Plus Pembrolizumab Shows Promise in Soft Tissue Sarcoma- Immutep's eftilagimod alpha (efti) combined with pembrolizumab and radiotherapy demonstrates significant efficacy in treating soft tissue sarcoma (STS).
- The combination therapy led to a greater than three-fold increase in tumor hyalinization/fibrosis compared to radiotherapy alone.
- 71.4% of patients achieved a pathologic response, defined as ≥35% hyalinization/fibrosis, with 9.5% achieving a complete pathologic response.
- The triple combination therapy was found to be safe, with no grade ≥3 toxicities related to efti and pembrolizumab.last yearImmutep's Efti Shows Promise in Neoadjuvant Soft Tissue Sarcoma Treatment- Immutep's EFTISARC-NEO Phase II trial evaluates eftilagimod alpha (efti) with radiotherapy and pembrolizumab in soft tissue sarcoma patients.
- Initial data from the trial shows encouraging results, with deep responses observed in the majority of the first six patients.
- The EFTISARC-NEO trial is the first to assess efti in a neoadjuvant setting, allowing for assessment of its impact on the tumor microenvironment.
- The trial is being conducted at the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw and is funded by a Polish government grant.last year