NCT02520245撤回1 期
Companion Study for Patients Who Completed Participation in a REGN2810 (Anti-PD-1) Clinical Study
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 9
- 主要终点
- Overall survival, from the first dose of study drug administered in the parent REGN2810 clinical study to death or date of last censoring
研究概览
简要总结
This study has been designed to collect long-term follow-up information for patients who received REGN2810 in other clinical studies and to allow re-treatment for eligible patients.
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
- 未提供
排除标准
- •A patient who meets any of the following criteria will be excluded from receiving re-treatment with REGN2810:
- •Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for irAEs.
- •Patients who experienced an irAE in while participating in another REGN2810 protocol who were unable to have their corticosteroid dose reduced to <10 mg per day prednisone equivalent within 12 weeks of toxicity.
- •Patients who developed ≥ Grade 2 uveitis in a prior REGN2810 protocol
- •Immunosuppressive corticosteroid doses (> 10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810
- •Active infection requiring therapy, including known infection with human immunodeficiency virus, or active infection with hepatitis B or hepatitis C virus.
- •History of pneumonitis within the last 5 years.
- •Any investigational or antitumor treatment within 30 days prior to the initial administration of REGN
- •History of documented allergic reactions or acute hypersensitivity reaction attributed of Grade ≥ 3 severity during or directly following an REGN2810 infusion
- •Known allergy to doxycycline or tetracycline. (precaution due to presence of trace components in REGN2810)
- •Breast-feeding
- •Positive serum pregnancy test
- •History within the last 5 years of an invasive malignancy other than the one treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment.
- •Acute or chronic psychiatric problems that, under the evaluation of the investigator, make the patient ineligible for participation
- •Unwilling to practice adequate contraception during the study until 6 months after the last dose of study drug
研究组 & 干预措施
Open-Label
Experimental
干预措施: REGN2810 (Drug)
结局指标
主要结局
Overall survival, from the first dose of study drug administered in the parent REGN2810 clinical study to death or date of last censoring
时间窗: up to 8 years
Safety measured by the number of patients with AEs, AEs leading to discontinuation, SAEs, drug-related AEs, Immune-related adverse events (irAEs), and death as outcome.
时间窗: up to 8 years
Safety includes the number of patients with AEs, AEs leading to discontinuation, SAEs, drug-related AEs, Immune-related adverse events (irAEs), and death as outcome.
次要结局
- Duration of disease control (time from best overall response of SD as well as PR and CR to time to first do documented disease progression)(up to 8 years)
- Response duration (time from best overall response of partial or complete response, to time to first documented disease progression)(up to 8 years)
研究者
研究点 (9)
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