EUCTR2015-004429-15-ES进行中（未招募）不适用
Phase II multicente, non randomized, open label trial of nivolumab in combination with ipilimumab in subjects with previously untreated metastatic uveal melanoma.
GRUPO ESPAÑOL MULTICISPLINAR DE MELANOMA0 个研究点开始时间: 2015年12月30日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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. Written informed consent must be provided;
- •2. Patients must have a histological diagnosis of uveal melanoma;
- •3. Progressive metastatic disease at baseline. Progressive disease is defined asnew or progressive lesions on cross-sectional imaging;
- •4. Age>18 years;
- •5. ECOG performance status (PS) 0 to 1;
- •6. Measurable disease by CT or MRI per RECIST 1.1 criteria;
- •7. No active or chronic infection with HIV, Hepatitis B or Hepatitis C;
- •8. Adequate organ function as determine by the following criteria:
- •a. Absolute neutrophil count (ANC) ?1.500/uL.
- •b.WBC ?2.000/uL.
- •c.Platelet count ?100x 103
- •d. Haemoglobin ?9 g/dl.
- •e. Serum creatinine <2.5 x upper limit of normal (ULN) and creatinine clearance >40 mL/min
- •f. Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) <3 x ULN, or <5 x ULN if liver abnormalities are due to underlying malignancy.
- •g. Total bilirubin <= 1.5 x ULN, (except patients with Gilbert?s Syndrome, who must have a total bilirubin less than 3.0 mg/dL).
- •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 48
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 48
排除标准
- •1) Prior systemic treatment for metastatic uveal melanoma.
- •2) Prior malignancy active within the previous 3 years except for locally curable cancers
- •that have been apparently cured, such as basal or squamous cell skin cancer,
- •superficial bladder cancer, carcinoma in situ of cervix or breast, or incidental prostate
- •3) Autoimmune disease: Patients with a history of inflammatory bowel disease,
- •including ulcerative colitis and Crohn?s Diseasse, are excluded from this study, as are
- •patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic
- •progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune
- •vasculitis [eg, Wegener?s Granulomatosis]); motor neuropathy considered of
- •autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis). Subjects
- •with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune
- •condition only requiring hormone replacement, psoriasis not requiring syatemic
- •treatment, or conditions not expected to recur in the absence of an external trigger are
- •permited to enroll.
- •4) Any underlying medical or psychiatric condition, which in the opinion of the
- •investigator will make the administration of nivolumab and ipilimumab hazardous or
- •obscure the interpretation of AEs, such as a condition associated with frequent
- •5) Any non-oncology vaccine therapy used for prevention of infectious diseases (for up
- •to 1 month before or after any dose of nivolumab and ipilimumab).
- •6) A history of prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4
- •antibody, or any other antibody or drug specifically targeting T-cell costimulation or
- •immune checkpoint pathways.
- •7) Concomitant therapy with any of the following: IL-2, interferon, or other non-study
- •immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other
- •investigation therapies; or chronic use of systemic corticosteroids, defined as >10mg
- •daily prednisone equivalents. Inhaled or topical steroids, and adrenal replacement
- •doses > 10 mg daily prednisone equivalents are permitted in the absence of active
- •autoimmune disease.
- •8) Active brain metastases or leptomeningeal metastases. Subjects with brain metastases
- •are eligible if these have been treated and there is no magnetic resonance imaging
- •(MRI) evidence of progression for at least 8 weeks after treatment is complete and
- •within 28 days prior to first dose of study drug administration. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day
- •prednisone quivalents) for at least 2 weeks prior to study drug administration.
- •9) Women of childbearing potential (WOCBP) as defined below, who:
- •a. are unwilling or unable to use an acceptable method of contraception to avoid
- •pregnancy for their entire study period and for at least 8 weeks after cessation
- •of study drug, or
- •b. have a positive pregnancy test at baseline, or
- •c. are pregnant or breastfeeding.
研究者
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