EUCTR2015-005464-42-ES进行中（未招募）1 期
A phase II study to assess the efficacy of the anti-PD-L1 antibody atezolizumab (MPDL3280A) administered with stereotactic ablative radiotherapy (SABR) in patients with metastatic tumours - SABR-PDL1
Gustave Roussy0 个研究点目标入组 180 人开始时间: 2017年7月4日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients must be 18 years of age or older.
- •2. Histologically or cytologically proven metastatic solid tumours including: colorectal (CRC, Microsatellite instability negative and positive) in treatment failure as per the current standard recommendation ; non-small cell lung cancer (NSCLC) pretreated by at least one line chemotherapy by platinum salt. Patients EGFR mutant can be included only if they have been treated with, or developed toxicity with or refused to be treated with anti-EGFR therapy ; renal cell carcinoma (RCC) pretreated by at least one line therapy by a tyrosin kinase inhibitor.
- •3. Patients with at least: one measurable metastasis by RECIST 1.1 eligible for SABR in terms of dose constraints at organ at risk and = 4 cm; and one not treated measurable metastasis by RECIST 1.1. If all tumour sites
- •are accessible to SABR, one of them will not be treated.
- •4.Evaluation by a radiation oncologist within 45 days prior to study registration, including imaging workup to document metastases
- •5. The irradiated and unirradiated tumour sites must be accessible to tumour biopsy (additional written consent required)
- •6. Patients may not have used any systemic anticancer treatment (approved or investigational agent) within 4 weeks prior to cycle 1 day 1
- •7. Life expectancy of more than 3 months
- •8. Patients must have adequate organ function
- •9. Patients must be affiliated to a social security system
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Metastases located to the brain and with clinical signs and/or leptomingeal carcinomatosis, or with indistinct borders making targeting not feasible
- •2. Metastasis localized to the central part of the chest and requiring irradiation
- •3. Irradiation by SABR should not include metastases located within 3 cm of the previously irradiated structures:
- •* Spinal cord previously irradiated to > 40 Gy
- •* Brachial plexus previously irradiated to > 50 Gy
- •* Small intestine, large intestine, or stomach previously irradiated to > 45 Gy
- •* Brainstem previously irradiated to > 50 Gy
- •* Lung previously irradiated with prior V20Gy > 30%
- •4. Irradiation required for cord compression and for superior veina cava syndrome.
- •5. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD1, or anti-PDL1 therapeutic antibodies
- •Patients who have received prior treatment with anti-CTLA-4 may be enrolled, provided at least 5 half-lives (approximately 75 days) have elapsed from the last dose of anti-CTLA-4 to the first dose of atezolizumab and there was no history of severe immune-mediated adverse effects from anti-CTLA-4 (NCI CTCAE Grade 3 and 4)
- •6. Treatment with systemic immunostimulatory agents (including but not limited to interferon-alpha (IFN-a) and interleukin-2 (IL-2) within 4 weeks or five half-lives of the drug (whichever is shorter) prior to Cycle 1, Day 1
- •7. Active or History of autoimmune or inflammatory disease
- •Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible
- •Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible
- •Patients with vitiligo or psoriasis or grave’s disease, not requiring systemic treatment within the last 2 years, are eligible
- •8. Any malignancy other than the disease under study in the past 5 years excepting skin cancers such as BCC or SCC
- •9. Uncontrolled tumour-related pain.
- •Patients requiring pain medication must be on a stable regimen at study entry.
- •Asymptomatic metastatic lesions whose further growth would likely cause functional deficits or intractable pain (e.g., epidural metastasis that is not presently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrollment.
- •10. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters (e.g., PleurX) are allowed.
- •11. Uncontrolled hypercalcemia (> 1.5 mmol/L ionized calcium or Ca > 12 mg/dL or corrected serum calcium > ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab.
- •Patients who are receiving bisphosphonate therapy or denosumab specifically to prevent skeletal events and who do not have a history of clinically significant hypercalcemia are eligible. However, patients who are receiving denosumab prior to enrollment must be eligible to receive bisphosphonate instead and willing to switch to bisphosphonate therapy while on the study.
- •12. Severe active co-morbidity as defined in the protocol
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