EUCTR2005-003265-16-BE进行中（未招募）不适用
A Randomized, Double-Blind, Multi-center, Phase II Fixed Dose Study of Multiple Doses of Ipilimumab (MDX-010) Monotherapy in Patients with Previously Treated Unresectable Stage III or IV MelanomaRevised Protocol 1, incorporating Amendment 2 - version 4.0, dated 15-Feb-06
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
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) Willing and able to give written informed consent;
- •2) Histologically confirmed malignant melanoma;
- •3) Measurable melanoma, as per modified WHO criteria;
- •4) Stage III (unresectable) or Stage IV melanoma;
- •5) Patient must have demonstrated one of the following in response to treatment with at
- •least one prior regimen (non-experimental or experimental) with the exception of a
- •CD137 agonist or CTLA-4 inhibitor or agonist: 1) relapse following an objective
- •response of PR or CR; or 2) failed to demonstrate an objective response of PR or CR
- •based on an assessment period of at least 12 weeks from prior regimen start; or 3)
- •inability to tolerate treatment due to toxicity;
- •6) Have a complete set of baseline (i.e., Screening) digital images of lesions and radiographic images, including, but not limited to: brain, bone, chest, abdomen and pelvis. All images must be of adequate quality as detailed in Section 3.3 of the protocol;
- •7) Required values for initial laboratory tests:
- •WBC = 2500/uL
- •ANC = 1000/uL
- •Platelets = 75 x 103/uL
- •Hemoglobin = 9 g/dL
- •Creatinine = 2.5 x ULN
- •AST = 3 x ULN for patients without liver metastasis
- •= 5 x ULN for patients with liver metastasis
- •Bilirubin = 3 x ULN, (except patients with Gilbert’s Syndrome, who must have a total bilirubin less than 3 mg/mL);
- •8) ECOG performance status of 0 or 1;
- •9) Life expectancy of = 16 weeks;
- •10) Accessible for treatment and follow-up;
- •11) Negative screening tests for HIV, HepB, and HepC. If positive results are not
- •indicative of true active or chronic infection, the patient can enter the study after
- •discussion and agreement between the Investigator and the Medical Monitor;
- •12) Male and female patients = 16 years of age (or minimum age of consent required per given regulatory authority);
- •Women of childbearing potential (WOCBP) must be using an adequate method of
- •contraception to avoid pregnancy throughout the study and for up to 8 weeks after the study in such a manner that the risk of pregnancy is minimized.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study.
- •2) Women who are pregnant or breastfeeding
- •3) Women with a positive pregnancy test on enrollment or prior to study drug administration.
- •4) Sexually active fertile men whose partners are WOCBP, unless using an adequate method of birth control;
- •5) Evidence of brain metastases on brain imaging (i.e., MRI or contrast CT);
- •6) Any other malignancy from which the patient has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix;
- •7) Primary ocular or mucosal melanoma;
- •8) Autoimmune disease: Patients with a documented history of inflammatory bowel
- •disease, including ulcerative colitis and Crohn’s disease are excluded from this study
- •as are patients with a documented history of symptomatic autoimmune disease (e.g.,
- •rheumatoid arthritis, systemic progressive sclerosis (scleroderma), Systemic Lupus
- •Erythematosus, autoimmune vasculitis [e.g., Wegener’s Granulomatosis]);
- •9) Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study medication hazardous to the patient, obscure the interpretation of adverse events (such as a condition associated
- •with frequent diarrhea) or may render the patient incapable of complying with the requirements of the study;
- •10) Concomitant therapy with any anti-cancer agent; immunosuppressive agents; any non-oncology vaccine therapy used for prevention of infectious diseases (for up to one month prior to or after any dose of study drug); surgery or radiotherapy (except as described in Sections 6.2.8.3 and 6.2.8.4); other investigational anti-cancer therapies; or chronic use of systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses);
- •11) Previous treatment with other investigational products, including cancer immunotherapy, within 30 days;
- •12) Previous treatment in another ipilimumab clinical trial or prior treatment with a CD137 agonist, CTLA-4 inhibitor or agonist;
- •13) Inability to provide adequate informed consent;
- •14) Prisoners or subjects who are compulsorily detained.
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