An Open-label, Multi-centric, Phase I, Evaluating the Safety and the Efficacy of Combination of Atezolizumab, Tiragolumab and and Stereotactic Body Radiation Therapy in Patients With Oligometastatic Multiorgan (IMMUNOs-SBRT)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Phase I : to evaluate safety of SBRT
研究概览
简要总结
This study (phase I clinical trial and expansion cohorts) will evaluate safety and efficacy of combination of atezolizumab and tiragolumab, with concomitant or sequential SBRT for four oligometastatic cancer cohorts. This study will allow to developpe one or several randomized Phase II clinical trials for the more promising indications
详细描述
This study will be composed of 2 stepms. First step will be a phase I with the aim to establish the recommended safety scheme of administration (concomitant or sequential) of tiragolumab + atezolizumab + SBRT. The phase I will enrolled only patients from the cohort 1 (metastatic non-small cell lung cancer).
The second step will be an expansion cohorts phase at the recommended scheme of administration. The second step will enrolled patients from 4 different cohorts (metastatic non-small cell lung cancer, metastatic bladder cancer, metastatic renal cell carcinoma, metastatic head and neck carcinoma).
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 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Atezolizumab + Tiragolumab + SBRT
Atezolizumab + Tiragolumab (every 21 days during 24 months or until progression) + SBRT (treatment will be delivered on 5 days).
The combination of SBRT and Immunotherapies will be performed using to different schemes. For the 6 first inclusions the combination will use a sequential scheme. If the safety criteria are respected the following patients will be able to be treated by concomitant scheme.
干预措施: Atezolizumab 60 MG/1 ML Intravenous Solution [TECENTRIQ] (Drug)
Atezolizumab + Tiragolumab + SBRT
Atezolizumab + Tiragolumab (every 21 days during 24 months or until progression) + SBRT (treatment will be delivered on 5 days).
The combination of SBRT and Immunotherapies will be performed using to different schemes. For the 6 first inclusions the combination will use a sequential scheme. If the safety criteria are respected the following patients will be able to be treated by concomitant scheme.
干预措施: Tiragolumab (Drug)
Atezolizumab + Tiragolumab + SBRT
Atezolizumab + Tiragolumab (every 21 days during 24 months or until progression) + SBRT (treatment will be delivered on 5 days).
The combination of SBRT and Immunotherapies will be performed using to different schemes. For the 6 first inclusions the combination will use a sequential scheme. If the safety criteria are respected the following patients will be able to be treated by concomitant scheme.
干预措施: Stereotactic body radiation therapy (SBRT) (Radiation)
结局指标
主要结局
Phase I : to evaluate safety of SBRT
时间窗: the first 4 weeks (28 days) after the first dose of study treatement for concomitant administration (3X8 Gy of radiotherapy and 3 dosing of immunotherapies)
Using the following DLTs (DLT are defined by the following events related to study treatments (SBRT and/or tiragolumab, atezolizumab) : * grade 3 pneumopathy (except if return to grade ≤2 within 7 days) * grade 3 radiation dermatitis (except if return to grade ≤2 within 2 weeks). * grade 4 of any other toxicity (except if return to ≤ G3 within 2 weeks) * for all any grade 4 adverse event which lead to treatment discontinuation of more than 7 days
次要结局
- Expansion cohort : overall survival (OS) following SBRT, atezolizumab and tiragolumab combination(Until the patient dies)
- Expansion phase : The 6-month progression free survival (PFS) rate after SBRT, atezolizumab and tiragolumab combination.(During 6 months after inclusion)
- Expansion cohort : The Duration of Response (DOR) and non progression duration (NPD) following SBRT, atezolizumab and tiragolumab combination(Throughout the treatment period (24 months))
- Expansion cohort : The long term safety of SBRT, atezolizumab and tiragolumab antibodies combination(Throughout the treatment period (24 months))
- Expansion cohort : Overall Response rate (ORR) and Non progression rate (NPR) following SBRT, atezolizumab and tiragolumab combination(18 weeks after inclusion)
- Expansion cohort : To evaluate abscopal effect(Throughout the treatment period (24 months))
研究者
Pr François GHIRINGHELLI
Scientific
Centr Georges Francois Leclerc