NCT03922880已完成1 期
Pilot Study Combining Arginine Depletion and Checkpoint Inhibition in Uveal Melanomas
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Safety as assessed by CTCAE version 5.0
研究概览
简要总结
This study is measuring the safety of the study drug, ADI-PEG 20, combined with immunotherapy drugs nivolumab and ipilimumab in treating patients with advanced uveal melanoma.
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
- •Advanced or unresectable melanoma of presumed uveal origin. Non-uveal melanomas with "malignant blue nevus" physiology with GNAQ, GNA11, CYSLTR2, or PLCB4 driver alterations are eligible upon discussion with the Principal Investigator.
- •Disease must be measurable according to RECIST 1.
- •Disease that has undergone local therapy in the past 30 days is not considered measurable unless the investigator has documented progression despite the local therapy.
- •Disease must be amenable to a biopsy attempt, in the opinion of the investigator.
- •Asymptomatic untreated brain metastases are allowed. Symptomatic brain metastases that have undergone local therapy with RT or surgery and have not required an increase in steroid dose in prior 2 weeks are allowed.
- •Note: Seizure prophylaxis with untreated brain metastases are allowed.
- •Patients must have an Easter Cooperative Oncology Group (ECOG) Performance Statue (PS) of 0-
- •Acceptable liver, renal, and hematological function:
- •Total bilirubin </= 1.5x upper limit of normal (ULN); patients with Gilbert's Syndrome must have bilirubin </= 3x ULN
- •Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) </= 3 x ULN (</= 5x if liver metastases are present)
- •Estimated glomerular filtration rate (GFR) >/= 30 mL/min using a cancer-specific GFR Model; the calculator found at:
- •http://tavarelab.cruk.com.ac.uk/JanowitzWilliamsGFR/
- •Hemoglobin >/= 9 g/dL
- •Neutrophils >/= 1.5 x 10^9/L
- •Platelets >/= 100 x 10^9/L
- •Female patients of childbearing potential and their partners (if male) and male patients with female partners of childbearing potential and their partners must agree to use a highly effective form of contraception for the duration of the study from the list below or agree to refrain from intercourse for the duration of the trial and for at least 30 days after the last administration of ADI-PEG20 and at least 150 days (if female) or 210 days (if male) after the final dose of ipilimumab and/or nivolumab whichever is later. Highly effective forms of contraception include the following:
- •combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal)
- •progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
- •intrauterine device
- •intrauterine hormone-releasing system
- •bilateral tubal occlusion
- •vasectomized partner
排除标准
- •Other active malignancy that in the opinion of the treating investigator will interfere with the assessments of efficacy for uveal melanoma in this study
- •History of seizure disorder not related to malignancy
- •Pregnancy or lactation
- •Expected non-adherence to protocol
- •Known allergy to E. coli drug products (such as GM-CSF)
- •Known allergy to pegylated compounds
- •Prior treatment with ADI-PEG20 or another experimental arginine deprivation strategy
- •Systemic anticancer therapy within 3 weeks or 1 cycle length, whichever is shorter, of first day of planned study therapy
- •Presence of treatment-related adverse events that have not recovered or stabilized at Grade 1 (excepting vitiligo and alopecia or treated endocrine conditions). AEs that are Grade 2 that are not felt to be a significant safety risk (e.g. rash, asymptomatic thyroiditis) may be allowable upon discussion with the Principal Investigator.
- •Active autoimmune disease or any condition requiring greater than 10mg prednisone per day equivalent or other immune suppressive medication (e.g. anti-TNF agents) within 14 days of study screening. Inhaled or topical steroids and adrenal replacements does of steroids >10mg prednisone are allowed in the absence of active autoimmune disease.
- •History of myocarditis or motor neuropathy of any grade
- •Gout flares within the past 28 days or sequelae of chronic gout, such as gouty arthritis, are excluded.
- •Note: Patients with asymptomatic hyperuricemia without arthralgias or arthritic symptoms are eligible, as are patients with known gout on chronic uric acid lowering medication who have not experienced a flare within 28 days
研究组 & 干预措施
Advanced Uveal Melanoma
Experimental
干预措施: ADI PEG20 (Drug)
Advanced Uveal Melanoma
Experimental
干预措施: Nivolumab (Drug)
Advanced Uveal Melanoma
Experimental
干预措施: Ipilimumab (Drug)
结局指标
主要结局
Safety as assessed by CTCAE version 5.0
时间窗: Up to 3 years
次要结局
- Objective Response Rate by RECIST 1.1(Up to 3 years)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and CisplatinMesotheliomaNCT02709512Polaris Group249
撤回
2 期
ADI-PEG20, Obesity and PrediabetesObesityPreDiabetesNCT05829239Washington University School of Medicine48
Unknown
2 期
A Clinical Trial of ADI-PEG 20TM in Patients With Malignant Pleural MesotheliomaMalignant Pleural MesotheliomaNCT01279967Barts & The London NHS Trust70
已完成
3 期
Ph 3 ADI-PEG 20 Versus Placebo in Subjects With Advanced Hepatocellular Carcinoma Who Have Failed Prior Systemic TherapyHepatocellular CarcinomaNCT01287585Polaris Group636
进行中（未招募）
1 期
Study of ADI-PEG 20, Venetoclax and Azacitidine in Acute Myeloid LeukemiaAcute Myeloid Leukemia, AdultNCT05001828Polaris Group38