2024-516125-31-02尚未招募1/2 期
(ACTME) Adoptive TIL therapy with low-dose PEG-IFNa plus nivolumab in metastatic melanoma
Leids Universitair Medisch Centrum (LUMC)1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2024年12月17日最近更新:
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Evaluation of the safety and toxicity of TIL and nivolumab, followed by the evaluation of the safety and toxicity of PEG-IFNa, nivolumab and TIL, according to CTCAE 4.0 criteria. Given the nature and severity of the disease, toxicity grade 3 or less and SAE related to treatment, but that do not result in treatment termination, are considered acceptable for continuation of the study.
研究概览
简要总结
Evaluating the safety and toxicity of first TIL and nivolumab and later of the combinatiën of TIL, PEG-IFNa and nivolumab based on the CTCAE 4.0 criteria
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Able and willing to give valid written informed consent
- •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.
- •Histologically or cytologically proven metastatic skin melanoma
- •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 - Patients have failed on standard treatment options
- •Patients with brain metastases have to be neurologically stable for at least 2 months and should not use dexamethasone
- •Presence of measurable progressive disease according to RECIST version 1.1
- •Expected survival of at least 3 months
- •WHO performance status ≤1
- •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
- •Viral tests must be performed at least 30 days before surgery: - Negative for HIV type 1/2, HTLV and TPHA - No HBV (hepatitis B virus) antigen or antibodies against HBc in the serum - No antibodies against HCV (hepatitis C virus) in the serum
排除标准
- •Patients with brain metastases who are neurologically unstable and/or use dexamethasone
- •Lack of availability for follow-up assessments
- •Subjects with a condition requiring systemic chronic steroid therapy (≥ 10mg/day prednisone or equivalent) orany 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.
- •Pregnancy or breastfeeding
- •Known allergy to penicillin or streptomycin (used during the culturing of T cells)
- •Other serious acute or chronic illnesses, e.g. active infections requiring antibiotics, bleeding disorders, or otherconditions requiring concurrent medications not allowed during this study
- •Clinically significant heart disease (NYHA Class III or IV)
- •Active immunodeficiency disease, autoimmune disease requiring immune suppressive drugs or autoimmune adverse events following treatment with checkpoint inhibitors. Vitiligo is not an exclusion criterion
- •Other malignancy within 2 years prior to entry into the study, except for treated non-melanoma skin cancer and in situ cervical carcinoma.
- •Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study
- •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
结局指标
主要结局
Evaluation of the safety and toxicity of TIL and nivolumab, followed by the evaluation of the safety and toxicity of PEG-IFNa, nivolumab and TIL, according to CTCAE 4.0 criteria. Given the nature and severity of the disease, toxicity grade 3 or less and SAE related to treatment, but that do not result in treatment termination, are considered acceptable for continuation of the study.
Evaluation of the safety and toxicity of TIL and nivolumab, followed by the evaluation of the safety and toxicity of PEG-IFNa, nivolumab and TIL, according to CTCAE 4.0 criteria. Given the nature and severity of the disease, toxicity grade 3 or less and SAE related to treatment, but that do not result in treatment termination, are considered acceptable for continuation of the study.
次要结局
- Secondary endpoints include the evaluation of the disease control rate assessed by physical examination and imaging studies (CTand/or MRI) and will be evaluated according to RECIST 1.1 and immune related response criteria (irRC). Furthermore, overallsurvival (OS) and progression-free survival (PFS) will be evaluated and immune related parameters will be analysed. Quality of lifeis already measured by the DMTR and will be assessed.
研究者
H.W. Kapiteijn
Scientific
Leids Universitair Medisch Centrum (LUMC)
研究点 (1)
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