NL-OMON56101招募中不适用
Adoptive TIL therapy with low-dose PEG-IFNa plus nivolumab in metastatic melanoma - ACTME
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 58
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. Age >= 18 years.
- •2. Histologically or cytologically proven metastatic skin melanoma.
- •3. Melanoma must be at one of the following AJCC 2009 stages:
- •-Unresectable (or residual) regional metastatic melanoma, i.e. in terms
- •of AJCC 2009 classification unresectable stage III melanoma, or
- •-Stage IV melanoma, i.e. distant metastatic disease (any T, any N, M1a,
- •M1b or M1c), and normal LDH.
- •4. Patients with brain metastases have to be neurologically stable for at least
- •2 months and should not use dexamethasone.
- •5. Presence of measurable progressive disease according to RECIST version 1.1.
- •6. Expected survival of at least 3 months.
- •7. WHO performance status <=1.
- •8. Within the last 2 weeks prior to study day 1, vital laboratory parameters
- •should be within normal range, except for the following laboratory parameters,
- •which should be within the ranges specified :
- •Lab Parameter Range
- •Hemoglobin >= 6,0 mmol/l
- •Granulocytes >= 1,500/µl
- •Lymphocytes >= 700/µl
- •Platelets >= 100,000/µl
- •Creatinine clearance >= 60 min/ml
- •Serum bilirubin <= 40 µmol/l
- •ASAT and ALAT <= 5 x the normal upper limit
- •LDH <= 2 x the normal upper limit
- •9. Viral tests:
- •-Negative for HIV type 1/2, HTLV and TPHA
- •-No HBV (hepatitis B virus) antigen or antibodies against HBc in the
- •-No antibodies against HCV (hepatitis C virus) in the serum
- •10. Able and willing to give valid written informed consent.
- •11. Progressive disease on prior treatment with f.e. BRAF-inhibitors,
- •MEK-inhibitors or immunotherapy, including anti-PD1 treatment. Systemic therapy
- •with BRAF-/MEK-inhibitors must have been discontinued for at least two weeks
- •before start of study treatment. Treatment with immunotherapy must have been
- •discontinued for at least four weeks before start of study treatment.
排除标准
- •1. Patients with brain metastases who are neurologically unstable and/or use
- •dexamethasone.
- •2. Clinically significant heart disease (NYHA Class III or IV).
- •3. Other serious acute or chronic illnesses, e.g. active infections requiring
- •antibiotics, bleeding disorders, or other conditions requiring concurrent
- •medications not allowed during this study.
- •4. Active immunodeficiency disease, or autoimmune disease requiring immune
- •suppressive drugs or autoimmune adverse events following treatment with
- •checkpoint inhibitors. Vitiligo is not an exclusion criterion
- •5. Other malignancy within 2 years prior to entry into the study, except for
- •treated non-melanoma skin cancer and in situ cervical carcinoma.
- •6. Mental impairment that may compromise the ability to give informed consent
- •and comply with the requirements of the study.
- •7. Lack of availability for follow-up assessments.
- •8. Pregnancy or breastfeeding.
- •9. Subjects with a condition requiring systemic chronic steroid therapy (>=
- •10mg/day prednisone or equivalent) or any immunosuppressive therapy within 14
- •days prior to planned date for first dose of study treatment. Topical, inhaled,
- •nasal and ophthalmic steroids, and adrenal replacement therapy are allowed.
- •10. Any serious or uncontrolled medical disorder or active infection that, in
- •the opinion of the investigator, may increase the associated with the
- •participation, study drug administration, or would impair the ability of the
- •patient to receive protocol therapy
- •11. Known allergy to penicillin or streptomycin (used during the culturing of
研究者
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