NL-OMON50102尚未招募2 期
Prospective randomized trial of an adjuvant therapy of completely resected Merkel Cell Carcinoma (MCC) with immune checkpoint blocking antibodies (Nivolumab, Opdivo®; Ipilimumab, Yervoy®) versus observation - ADMEC-O
niversity Hospital Essen0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. The patient is willing and able to give written informed consent.
- •2. Central histological confirmation of diagnosis of Merkel cell carcinoma
- •3. All MCC manifestations have been completely resected by surgery within 12
- •weeks before enrolment.
- •4. No currently present metastases (as confirmed by standard imaging studies
- •(e.g. suggested by S2k guidelines).
- •5. No previous systemic therapy for MCC.
- •6. Required values for initial laboratory tests: *
- •WBC >= 2000/uL *
- •ANC >= 1000/uL *
- •Platelets >= 75 x 103/uL *
- •Hemoglobin >= 8 g/dL (>= 80 g/L) *
- •Creatinine <= 2.0 x ULN *
- •AST/ALT <= 2.5 x ULN *
- •Total Bilirubin <= 2.0 x ULN (except patients with Gilbert*s Syndrome, who must
- •have a total bilirubin less than 3.0 mg/dL)
- •7. ECOG performance status of 0 or 1.
- •8. No active or chronic infection with HIV, Hepatitis B or C.
- •9. Men and women, >= 18 years of age.
- •10. Women of childbearing potential (WOCBP) must be using an adequate method of
- •contraception (Pearl-Index < 1) to avoid pregnancy during treatment phase and
- •for additional 5 months after the last dose of nivolumab, in such a manner that
- •the risk of pregnancy is minimized. WOCBP include any female who has
- •experienced menarche and who has not undergone successful surgical
- •sterilization (hysterectomy, bilateral tubal ligation, or bilateral
- •oophorectomy) or is not post-menopausal. WOCBP must have a negative serum or
- •urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG)
- •within 72 hours before the start of nivolumab.
- •11. Men of fathering potential must be using an adequate method of
- •contraception to avoid conception during treatment phase and for additional 7
- •months after the last dose of nivolumab) in such a manner that the risk of
- •pregnancy is minimized.
排除标准
- •1. Autoimmune disease: Patients with a history of inflammatory bowel disease,
- •including ulcerative colitis and Crohn*s Disease, are excluded from this study,
- •as are patients with a history of symptomatic disease requiring systemic
- •steroids (e.g., rheumatoid arthritis, systemic progressive sclerosis, systemic
- •lupus erythematosus, autoimmune vasculitis); autoimmune motor neuropathy.
- •2. Other serious illnesses, e.g., serious infections requiring i.v.
- •antibiotics.
- •3. The patient is known to be positive for Human Immunodeficiency Virus (HIV)
- •or other chronic infections (HBV, HCV) or has another confirmed or suspected
- •immunosuppressive or immune deficient condition.
- •4. Any underlying medical or psychiatric condition, which in the opinion of the
- •investigator will make the administration of nivolumab hazardous or obscure the
- •interpretation of AEs, such as a condition associated with frequent diarrhea.
- •5. Any non-oncology vaccine therapy for up to 1 month before or after any dose
- •of nivolumab.
- •6. A history of prior or current treatment with a T cell potentiating agent
- •(e.g. IL-2, interferon, anti-CTLA-4, anti-CD137, anti-PD1, anti-PD-L1, or
- •anti-OX40 antibody).
- •7. Chronic use of immunosuppressive agents or systemic corticosteroids.
- •8. Women of childbearing potential (WOCBP), defined above in Section 5.1, who:
- •are unwilling or unable to use an acceptable method of contraception to avoid
- •pregnancy during treatment phase and for additional 5 months after the last
- •dose of investigational product *
- •have a positive pregnancy test at baseline *
- •are pregnant or breastfeeding.
- •9. The patient has psychiatric or addictive disorders that may compromise
- •his/her ability to give informed consent or to comply with the trial
- •procedures.
- •10. Prisoners or subjects who are compulsorily detained (involuntarily
- •incarcerated) for treatment of either a psychiatric or physical (e.g.,
- •infectious) illness.
- •11. Men of reproductive potential unwilling to use an adequate method to avoid
- •pregnancy during treatment phase and for additional 7 months after the last
- •dose of investigational product.
- •12. Use of any investigational or non-registered product (drug or vaccine)
- •other than the study treatment.
研究者
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