NL-OMON50672招募中2 期
Multicenter Phase 2 Study to Identify the Optimal neo-Adjuvant Combination Scheme of Ipilimumab and Nivolumab (OpACIN-neo) and Personalized Response-driven Adjuvant Combination (PRADO extension cohort) - OpACIN-neo PRADO
ederlands Kanker Instituut0 个研究点目标入组 80 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Adults at least 18 years of age
- •World Health Organization (WHO) Performance Status 0 or 1
- •Cytologically and histologically confirmed resectable stage III melanoma with
- •one or more macroscopic lymph node metastases (measurable according to RECIST
- •1.1), that can be biopsied, and no history of in-transit metastases within the
- •last 6 months
- •No other malignancies, except adequately treated and a cancer-related
- •life-expectancy of more than 5 years
- •Patient willing to undergo triple tumor biopsies and extra blood withdrawal
- •during screening and in case of relapse
- •No prior immunotherapy targeting CTLA-4, PD-1 or PD-L1
- •No immunosuppressive medications within 6 months prior study inclusion
- •Screening laboratory values must meet the following criteria: WBC >=
- •2.0x109/L, Neutrophils >=1.5x109/L, Platelets >=100 x109/L, Hemoglobin >=5.5
- •mmol/L, Creatinine <=1.5x ULN, AST <= 1.5 x ULN, ALT <= 1.5 x ULN, Bilirubin <=1.5
- •Normal LDH
排除标准
- •Distantly metastasized melanoma
- •Brain metastases
- •History of in-transit metastases within the last 6 months
- •No measurable lesion according to RECIST 1.1
- •Subjects with any active autoimmune disease or a documented history of
- •autoimmune disease, or history of syndrome that required systemic steroids or
- •immunosuppressive medications, except for subjects with vitiligo or resolved
- •childhood asthma/atopy
- •Prior CTLA-4 or PD-1/PD-L1 targeting immunotherapy
- •Radiotherapy prior or post-surgery (except for non-responders in PRADO
- •extension cohort; in this group is adjuvant radiotherapy allowed)
- •Patients who test positive for hepatitis B or C or HIV.
研究者
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