EUCTR2017-000760-15-IT进行中（未招募）1 期
A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN 144) for Treatment of Patients with Metastatic Melanoma - Study of LN-144 in the Treatment of Patients with Metastatic Melanoma
IOVANCE BIOTECHNOLOGIES, INC0 个研究点目标入组 85 人开始时间: 2020年11月4日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 85
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
- •a. Patients with unresectable or metastatic melanoma (Stage IIIc or
- •Stage IV) who progressed following = 1 lines of prior systemic
- •therapy, including immune checkpoint inhibitor (eg, anti-PD-1), and
- •if BRAF mutation-positive, after BRAF inhibitor systemic therapy.
- •Patients must have no other therapy options that are expected to have
- •significant benefit in the opinion of the Investigator and must have:
- •At least 1 measurable target lesion, as defined by RECIST 1.1.
- •Lesions in previously irradiated areas should not be selected as
- •target lesion, unless treatment was = 3 months prior, and there
- •has been demonstrated disease progression in the lesion
- •At least 1 resectable target lesion to generate TIL of a minimum
- •1.5 cm in diameter post-resection; surgical removal with minimal
- •morbidity (defined as any procedure for which expected
- •hospitalization is = 3 days)
- •b. Patients must be = 18 years and = 70 years of age at the time of
- •consent. Enrollment of patients > 70 years of age may be allowed
- •after consultation with the Medical Monitor
- •c. Patients must have an Eastern Cooperative Oncology Group (ECOG)
- •performance status of 0 or 1 and an estimated life expectancy of
- •= 3 months
- •d. In the opinion of the Investigator, patient must be able to complete all
- •study-required procedures
- •e. Patients of childbearing potential or their partners of childbearing
- •potential must be willing to practice an approved method of birth
- •control during treatment and for 12 months after receiving last
- •protocol-related therapy
- •Approved methods of birth control are as follows:
- •Combined (estrogen and progestogen containing) hormonal birth
- •control associated with inhibition of ovulation: oral; intravaginal;
- •transdermal
- •Progestogen-only hormonal birth control associated with
- •inhibition of ovulation: oral; injectable; implantable
- •Intrauterine device (IUD)
- •Intrauterine hormone-releasing system (IUS)
- •Bilateral tubal occlusion
- •Vasectomized partner
- •True sexual abstinence when this is in line with the preferred and
- •usual lifestyle of the patient. Periodic abstinence (eg, calendar
- •ovulation, symptothermal, post-ovulation methods) is not
- •acceptable.
- •f. Patients must have the following hematologic parameters:
- •Absolute neutrophil count (ANC) = 1000/mm3
- •Hemoglobin = 9.0 g/dL
- •Platelet count = 100,000/mm3
- •g. Patients must have adequate organ function:
- •Serum alanine transaminase (ALT)/ serum glutamic-pyruvic
- •transaminase (SGPT) and aspartate transaminase (AST)/serum
- •glutamic oxaloacetic transaminase (SGOT) = 3 times the upper limit of normal [ULN]), patients with liver metastasis = 5 times
- •An estimated creatinine clearance (eClCr) = 40 mL/min using the
- •Cockcroft-Gault formula at Screening
- 另有 14 项未显示
排除标准
- •a. Patients with melanoma of uveal/ocular origin
- •b. Patients who have received an organ allograft or prior cell transfer
- •therapy that included a nonmyeloablative or myeloablative
- •chemotherapy regimen (not applicable for patients in the retreatment
- •c. Patients with symptomatic and/or untreated brain metastases (of any
- •size and any number)
- •Patients with definitively treated brain metastases may be
- •considered for enrollment after discussion with the Medical
- •Monitor, and must be stable for = 2 weeks prior to the start of
- •d. Patients who are pregnant or breastfeeding
- •e. Patients who are on a systemic steroid therapy at a dose of > 10 mg
- •of prednisone or equivalent per day
- •A short course of higher-dose steroid therapy is allowed in cases
- •of exacerbation of known disease or for treatments of new acute
- •f. Patients who have active medical illness(es) that in the opinion of the
- •Investigator would pose increased risk for study participation that
- •may include active systemic infections, such as syphilis, or any other
- •infections requiring antibiotics, coagulation disorders, or other active
- •major medical illnesses of the cardiovascular, respiratory, or immune
- •g. Patients who have any form of primary immunodeficiency (such as
- •severe combined immunodeficiency disease [SCID] or acquired
- •immunodeficiency syndrome [AIDS])
- •h. Patients who have a history of hypersensitivity to any component or
- •excipient of the TIL therapy and other study drugs:
- •NMA-LD (cyclophosphamide, mesna, and fludarabine)
- •Antibiotics of the aminoglycoside group (ie, streptomycin,
- •gentamicin)
- •Any component of the TIL infusion product formulation
- •including dimethyl sulfoxide [DMSO], human serum albumin
- •[HSA], IL-2, and dextran-40
- •i. Patients who have a left ventricular ejection fraction (LVEF) < 45%
- •or New York Heart Association (NYHA) functional classification
- •> Class 1 at Screening. All patients must have echocardiogram
- •(ECHO) or multiple gated acquisition scan (MUGA) at Screening.
- •For patients = 60 years or patients who have a history of ischemic
- •heart disease, chest pain, or clinically significant atrial and/or
- •ventricular arrhythmias, a cardiac stress tests must be performed
- •showing LVEF =45%, and if any wall movement abnormalities,
- •they must be reversible.
- •j. Patients who have obstructive or restrictive pulmonary disease and
- •have a documented FEV1 (forced expiratory volume in 1 second) of = 60%
- •k. Patients who have had another primary malignancy within the
- •previous 3 years (with the exception of carcinoma in situ of the
- •breast, cervix, or bladder, localized prostate cancer and nonmelanoma
- •skin cancer that has been adequately treated)
- •l. Patients who have been shown to be BRAF mutation positive (V600),
- •but have not received prior systemic therapy with a BRAF-directed
- •kinase inhibitor
- •m. Patients who have received a live or attenuated vaccine within
- •28 days of the start of NMA-LD
- 另有 9 项未显示
研究者
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