EUCTR2010-019356-50-IT进行中（未招募）不适用
A Phase II Study of the Combination of Ipilimumab and Fotemustine in Patients with Unresectable Locally Advanced or Metastatic Malignant Melanoma - NIBIT-M1
IBIT (NETWORK ITALIANO PER LA BIO-IMMUNOTERAPIA DEI TUMORI)0 个研究点开始时间: 2010年4月27日最近更新:
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) Signed Written Informed Consent a) Willing and able to give written informed consent. 2) Target Population a) Histologic diagnosis of malignant melanoma; b) Stage III (unresectable) or Stage IV melanoma; c) Maximum 1 line of chemotherapy for advanced disease allowed; d) No prior chemotherapy within 4 weeks from treatment start (6 weeks in case of nitrosourea); e) No previous systemic corticosteroid therapy within 10 days; f) Prior adjuvant treatment with IFN or other immunotherapy allowed; g) Asymptomatic brain metastases allowed; h) Measurable disease; i) Prior treatment of brain metastases. In case stereotactic radiotherapy (or surgery) was not applicable, whole brain radiotherapy should have been performed; j) Have a full set of baseline (ie, Screening) radiographic images, including, but not limited to: brain, chest, abdomen, pelvis and soft tissue and assessment of skin lesions. All images must be of adequate quality as detailed in Section 6.4; k) Life expectancy ? 16 weeks
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •4) Sex and Reproductive Status a) 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; b) Women who are pregnant or breastfeeding; c) Women with a positive pregnancy test on enrollment or prior to investigational product administration; d) Sexually active fertile men not using effective birth control if their partners are WOCBP. 5) Target Disease Exceptions a) 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; b) Primary ocular or mucosal melanoma. 6) Medical History and Concurrent Diseases a) Symptomatic brain metastases requiring immediate local intervention (radiotherapy (RT) and/or surgery); b) 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 (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune vasculitis [eg, Wegener?s Granulomatosis] and autoimmune hepatitis. Subjects with motor neuropathy considered of autoimmune origin (eg, Guillain-Barre Syndrom) are also excluded from this study; c) 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. 7) Prohibited Treatments and/or Therapies a) Concomitant therapy with any anti-cancer agent; immunosuppressive agents; any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month prior to or after any dose of study drug); surgery or radiotherapy (except as described in Sections 5.5.1 and 5.5.2); other investigational anti-cancer therapies; or chronic use of systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses); b) Previous treatment with other investigational products, including cancer immunotherapy, within 30 days; c) Previous enrollment in another clinical trial or prior treatment with a CD137 agonist or anti-CTLA-4 and/or fotemustine. 8) Other Exclusion Criteria a) Prisoners or subjects who are involuntarily incarcerated; b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
研究者
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