EUCTR2019-003300-12-SE进行中（未招募）1 期
A Phase I/II Trial Investigating LOAd703 in Combination with Atezolizumab in Malignant Melanoma
okon Pharma AB0 个研究点目标入组 50 人开始时间: 2019年10月4日最近更新:
适应症
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
- 50
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
- •1. Pathological confirmation of melanoma.
- •2. A life expectancy of at least 3 months as per investigator.
- •3. Patients has locally advanced melanoma or metastatic melanoma, but not eligible for complete resection of melanoma.
- •4. The patient has measurable disease (e.g., measurable tumor lesions must be present that can accurately be measured in at least one dimension with a minimum size of 10 mm by CT scan and MRI, 10 mm caliper measurement by clinical exam (when superficial), and/or 20 mm by chest X-ray).
- •5. Patient has at least one injectable tumor lesion that has not been irradiated or has been irradiated but disease progression documented at the site subsequent to radiation therapy.
- •6. The patient has received appropriate treatment with an anti-PD-1 or anti-PD-L1 antibody with or without an anti-CTLA4.
- •7. Patients whose advanced melanoma has a B-Raf mutation must have received appropriate therapy with tyrosine kinase inhibitor(s) and/or MEK inhibitor as assessed by the investigator.
- •8. Age = 18 years.
- •9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- •10. Serum albumin = 2.5 g/dL.
- •11. Absolute neutrophil count (ANC) = 1.0 x 10e9/L.
- •12. Platelet count = 100 x 10e9/L.
- •13. Prothrombin (INR) = 1.5 or prothrombin time (PT) = 1.5 times ULN; and either partial thromboplastin time or activated partial thromboplastin time (PTT or aPTT) = 1.5 times the ULN.
- •14. Bilirubin < 1.5 times the institutional upper limit of normal (ULN).
- •15. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5 (=5 if liver metastases are present) times the institutional ULN.
- •16. The patient must have signed informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1.Malignant melanoma that is uveal. 2.Subjects considered by the investigator to have a rapid progression of melanoma. 3. Patients must not have greater than 3 cerebral melanoma metastases, and/or clinically active cerebral melanoma metastases, and/or a requirement for corticosteroid therapy, and/or carcinomatous meningitis regardless of clinical stability. 4.Any concurrent treatment that would interfere with the effect mechanisms of atezolizumab and LOAd703, including, but not limited to, continuous high-dose corticosteroids (>10 mg per day), lymphodepleting antibodies, or cytotoxic agents. 5.Treatment with inhibitors of immune function, such as lymphotoxic monoclonal antibodies (e.g., alemtuzumab), or rapamycin/rapamycin analogs, or cytotoxic agents within 21 days of first dose of LOAd703/atezolizumab. 6.Therapeutic treatment with systemic antibiotics within 14 days of first dose of LOAd703/atezolizumab. 7.Treatment with biologic therapy within 21 days of first dose of LOAd703/atezolizumab. 8. Treatment with cytotoxic anticancer therapy within 14 days of the first dose of LOAd703/atezolizumab. 9. Treatment with wide-field radiation within 14 days of the first dose of LOAd703/atezolizumab. 10. Prior treatment with an adenovirus-based gene therapy. 11. Use of any investigational agents within 21 days of the first dose of LOAd703/atezolizumab). 12. The use of systemic immunostimulatory agents (including, but not limited to, interferons and IL2) are prohibited within 21 days or 5 half-lives (whichever is longer) of the first dose of LOAd703/atezolizumab. 13. Failed resolution/improvement of AEs including those related to anti-PD-1/anti-PD-L1 antibody back to grade 0-1 and requirementfo treamtent with >10 mg/day prednisone (or equivalent) for at least two weeks prior to registration. 14. History of CTCAE grade 4 immune-related AEs from monotherapy using an anti-PD-1/anti-PD-L1 antibody 15. History of CTCAE grade 4 AE that require steroid treatment (<10 mg/day prednisone or equivalent) for >12 weeks.
- •16. Patients requiring warfarin are not egible (low molecular weight heparin
- •is permitted).
- •17.Women who are pregnant (as confirmed by pregnancy test during screening in applicable patients), breastfeeding, or planning to become pregnant during the study period, or women of childbearing potential who are not using acceptable highly effective contraceptive methods. A woman is considered of childbearing potential if she is not surgically sterile or is less than 1 year since her last menstrual period. The following are acceptable as highly effective contraceptive methods: combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion and vasectomized partner or abstinence of heterosexual intercourse during the entire study period (depending on the preferred and usual life style of the subject). 18.Men who do not consent to the use of condoms during intercourse during study participation or has a partner of childbearing potential, who will not use any of the highly effective contraceptive methods exemplified in exclusion criteria no 17. 19.Known active hepatitis B or C infection, or HIV infection.
- •20.Patients with active, severe autoimmune disease or immune defici
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