KCT0004145尚未招募未知
The combination of anti-PD-1 blockade with radiotherapy in previously untreated metastatic melanoma
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Subject has provided informed consent prior to initiation of any study-specific activities/procedures
- •2. Male or female age = 20 years at the time of informed consent
- •3. Histologically confirmed diagnosis of malignant melanoma
- •4. unresectable stage IIIB, IIIC, IVM1a, IVM1b or IVM1c melanoma
- •5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •6. Screening labs performed within 14 days of randomization demonstrating adequate hematologic, coagulation, liver, and kidney functions
- •7. Indications for radiotherapy
- •8. BRAF status must be checked, but patient is eligible regardless of BRAF mutations (BRAF V600 mutation positive patients are eligible)
排除标准
- •1. Ocular melanoma
- •2. Active, uncontrolled brain metastasis (requires 1 month of washout period radiation therapy, surgery or gamma-knife surgery)
- •3. Previous treatment with chemotherapy, a CTLA-4 or PD-1/PD-L1 antagonist agent, including treatment in adjuvant setting for immunotherapy
- •4. Concurrent medical disease which would significantly limit full compliance with the study such as, but not limited to the following: heart failure (III, IV as per NYHA classification), renal insufficiency, active infection (requires negative gest for clinically suspected HIV, hepatitis B virus, hepatitis C virus).
- •If positive results are not indicative of true active or chronic infection, the subject may enter the study after discussion and agreement between the investigator and medical director.
- •5. Has known malignancy diagnosed within three years that is progressing and requires active treatment are excluded.
- •6. Autoimmune disease requiring chronic treatment with systemic corticosteroids or any other immunosuppressive agents 7 days prior to inclusion
- •-Exception: intranasal glucocorticoid and intra-articular steroid injections
- •-Exception: administration of prednisolone 10mg/day or equivalent as physiologic dose for adrenal insufficiency
- •-Exception: steroid as pre-medication to prevent anaphylactic shock (contrast with CT, other systemic treatment)
- •8. Has known psychiatric or substance abuse disorders that would interfere with cooperation requirements of the trial
- •9. Lack of availability for clinical follow-up assessments
研究者
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