PER-032-06已完成未知
AN EXPLORATORY STUDY TO DETERMINE POTENTIAL PREDICTIVE MARKERS OF RESPONSE AND / OR TOXICITY IN PATIENTS WITH MALIGNANT NON-EXTRAPABLE MELANOMA IN STAGE III OR IV TREATED WITH IPILIMUMAB (MDX-010 / BMS-734016) AT TWO LEVELS OF DOSE
试验速览
- 阶段
- 未知
- 状态
- 已完成
研究概览
简要总结
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研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •a) Written informed consent, voluntarily signed and dated. It must be obtained before performing the procedures related to the protocol.
- •b) Able to comply with visits / procedures required by the protocol.
- •c) Life expectancy of at least 4 months.
- •d) ECOG 0-1 performance status score.
- •e) Histological or cytological diagnosis of non-resectable malignant melanoma of Stage III or IV.
- •f) A resected tumor biopsy or recent center should be submitted before and after treatment for the analysis of biomarkers and predictive markers. It is preferred that the biopsies are obtained from the same organ.
- •g) Disease susceptible of measurement.
- •h) Values adequate for initial laboratory tests.
- •i) It must have been at least 4 weeks since the last chemotherapy, immunotherapy, hormonal therapy, radiotherapy or major surgery and the beginning of the protocol therapy.
- •j) The toxicity related to the previous therapy must have returned to ≤ grade 1, to the baseline or be considered irreversible.
- •k) Men and women 18 years and older. Women of childbearing age (WOCBP) should be using an adequate contraceptive method. The WOCBP must have a negative pregnancy test within 72 hours prior to the start of the study medication.
排除标准
- •a) WOCBPs that are not willing or able to use an acceptable method to avoid pregnancy during the entire study period and for at least 12 weeks after the study.
- •b) WOCBPs that use a prohibited method of contraception.
- •c) Women who are pregnant or breastfeeding.
- •d) Women with a positive pregnancy test at the time of enrollment or before administration of the study drug.
- •e) Sexually active fertile men who are unwilling or unable to use a barrier contraceptive or whose partners are WOCBP who do not use a method of birth control from the moment of enrollment and for 12 weeks after participation in the study.
- •f) Any other malignant disease that the patient has suffered for less than 5 years.
- •g) Ocular melanoma.
- •h) Central nervous system (CNS) metastasis untreated and active.
- •i) Autoimmune disease.
- •j) Any underlying medical condition, which makes the administration of the study drug dangerous or hinders the interpretation of adverse events.
- •k) Positive screening tests for HIV, HepB and HepC. If the positive results are not indicative of true active or chronic infection, the patient can be admitted after being discussed and agreed with the BMS Medical Monitor.
- •l) Uncontrolled or significant cardiovascular disease.
- •m) Pre-treatment with an anti-CLTA-4 antibody.
- •n) Use of any immunosuppressive treatment within 4 weeks prior to Day 1 of treatment.
- •m) Exposure to any of the products under investigation within 4 weeks prior to Day 1 of the treatment.
- •o) Drugs of which it is generally accepted that they have a risk of originating Torsade de Pointes. Patients who have discontinued any of these medications should have a drug withdrawal period of at least 5 days or at least 5 half-lives of the drug (whichever is longer) before the first dose of MDX-010 ( BMS-734016).
- •p) Concomitant therapy with any of the following: IL-2, interferon or other anti-melanoma immunotherapy regimens that are not in the study; cytotoxic chemotherapy; immunosuppressive agents; other therapies in research or the chronic use of systemic corticosteroids.
- •q) Concomitant chemotherapy is prohibited.
- •r) Prisoners or patients who are required to be detained for the treatment of either a psychiatric or physical illness should not be enrolled in this study.
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