EUCTR2005-002827-15-IT进行中（未招募）不适用
A PHASE 3, OPEN LABEL, RANDOMIZED, COMPARATIVE STUDY OF TICILIMUMAB AND EITHER DACARBAZINE OR TEMOZOLOMIDE IN PATIENTS WITH ADVANCED MELANOMA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- PFIZER
- 入组人数
- 630
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
- •Histologically confirmed melanoma that is not surgically curable and is either: ? Stage IV (AJCC 6th edition) OR ? Stage IIIC (AJCC 6th edition) with N3 status for regional lymph nodes and in-transit or satellite lesions NOTE: Patients with mucosal melanoma will not be excluded. All HLA types are eligible. 2. Patients must either have measurable disease or have non-measurable disease which can be evaluated for objective response, as defined here: ? Measurable Disease. Patient has at least one lesion that meets the following criteria: Measurable lesions can be accurately measured in at least one dimension. Lesions on CT scan must have longest diameter >/= 2.0 cm using conventional techniques or >/= 1.0 cm with spiral CT scan. Skin lesions must have longest diameter at least 1.0 cm. Clinically detected lesions must be superficial (eg, skin nodules), and the longest diameter must be >/= 2.0 cm. Palpable lymph nodes >2.0 cm should be demonstrable by CT scan. If the measurable disease is restricted to a solitary lesion, its neoplastic nature must be confirmed by cytology or histology. Tumor lesions that are situated in a previously irradiated area will be considered measurable only if progression is documented following completion of radiation therapy. ? Non-Measurable Disease. Patients with non-measurable disease (ie, without lesions that meet the above criteria for measurability) must have evidence of disease confirmed by pathology (ie, needle aspirate/biopsy). Patients with previously irradiated lesions must have documented progression or disease outside the radiation port. 3. ECOG performance status of 0 or 1 4. Age >/= 18 years or older 5. Adequate bone marrow, hepatic, and renal function determined within 14 days prior to randomization, defined as: ? Absolute neutrophil count >/= 1.5 x 10(9) cells/L ? Platelets >/= 100 x 10(9)/L ? Hemoglobin >/= 10 g/dL ? Aspartate and alanine aminotransferases (AST, ALT) /=60 mL/min 6. Serum lactic acid dehydrogenase (LDH) Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-6
排除标准
- •1. Melanoma of ocular origin 2. Received any systemic therapy for metastatic melanoma except post-surgical adjuvant treatment with alpha-interferon for resected Stage II or Stage III disease. Patients who received alpha-interferon must be at least 30 days from the last dose, and must have documented tumor progression since the last dose. Note: Prior chemotherapy, biochemotherapy, cytokine therapy (other than alpha-interferon), or vaccine therapy are not allowed. Prior intralesional injections and prior isolated limb perfusion therapy are not allowed. Prior resection for Stage III or Stage IV disease is allowed as long as the patient has unresectable lesions at the time of randomization. 3. History of brain metastases 4. Received any prior CTLA4 inhibiting agent (eg MDX-010) 5. Patients previously randomized on this protocol 6. History of chronic inflammatory or autoimmune disease (eg, Addison's disease, multiple sclerosis, Graves' disease, Hashimoto's thyroiditis, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, hypophysitis, pituitary disorders, etc.). Note: Active vitiligo or a history of vitiligo will not be a basis for exclusion. 7. History of uveitis or melanoma-associated retinopathy 8. History of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis of any origin 9. History of hepatitis due to Hepatitis B virus or Hepatitis C virus 10. Any serious uncontrolled medical disorder or active infection that would impair the patient's ability to receive study treatment 11. Received an immunosuppressive dose of corticosteroids or other immunosuppressive medication (eg, methotrexate, rapamycin) within 30 days of randomization. Note: Patients with adrenal insufficiency may take up to 5 mg of prednisone or equivalent daily. Topical and inhaled corticosteroids in standard doses are allowed. 12. History of other malignancy, except for adequately treated basal cell carcinoma or squamous cell skin cancer or carcinoma in situ of the cervix, unless the patient has been disease-free for at least 5 years 13. Breast-feeding 14. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol
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