EUCTR2005-002051-41-AT进行中（未招募）不适用
A Multi-Center Single Arm Phase II Study of MDX-010 (BMS-734016) Monotherapy in Patients with Previously Treated Unresectable Stage III or IV Melanoma.Revised Protocol 02, incorporating Amendment 06, Administrative Letter 01, 02, and 03; and Pharmacogenetics Blood Sample Amendment #01, version 1.0 dated 01-Jul-05, Pharmacogenomics Archived Tissue Sample Amendment #03, version 1 dated 29-Mar-06 and Pharmacogenomic Biomarker Sample Amendment #04, version 1 dated 03-Apr-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
- 170
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) Histologic diagnosis of malignant melanoma;
- •3) Measurable melanoma, as per modified WHO criteria;
- •4) Stage III (unresectable) or Stage IV melanoma;
- •5) Patient must have progressed during or after at least one prior therapeutic regimen containing at least one of the following: IL-2, dacarbazine, paclitaxel, carboplatin, fotemustine, or temozolamide.
- •6) Have a full set of baseline (i.e., Screening) digital images of cutaneous 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 3.3.1 of the protocol.
- •7) Life expectancy = 16 weeks;
- •8) ECOG performance status of 0 or 1 (see Protocol Appendix 4);
- •9) 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 3.0 mg/mL);
- •10) 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 CRO Medical Monitor.
- •11) Male and female patients = 16 years of age (or minimum age of consent required per given regulatory authority);
- •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
- •Sex and Reproductive Status
- •1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire period of the study and for up to 8 weeks after the study;
- •2) Women who are pregnant or breastfeeding;
- •3) Women with a positive pregnancy test at enrollment or prior to study drug administration;
- •4) Sexually active fertile men whose partners are WOCBP, unless using an adequate method of birth control;
- •Target Disease Exceptions
- •5) Any 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, carcinoma in situ of the cervix;
- •6) Primary ocular or mucosal melanoma;
- •Medical History and Concurrent Disease
- •7) Evidence of brain metastases on brain MRI or contrast CT;
- •8) Autoimmune disease: Patients with a documented history of Inflammatory Bowel Disease, including ulcerative colitis and Chrohn’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 condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea;
- •Prohibited Therapies and/or Medications
- •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 enrollment in another clinical trial or prior treatment with a CD137 agonist or CTLA-4 inhibitor or agonist;
- •Other Exclusion Criteria
- •13) Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled in this study.
研究者
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