EUCTR2015-000449-21-IT进行中（未招募）1 期
A Phase I/II, open label, multicenter study of the safety and efficacy of LAG525 single agent and in combination with PDR001 administered to patients with advancedmalignancies. - NA
OVARTIS FARMA S.P.A.0 个研究点目标入组 416 人开始时间: 2021年2月1日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 416
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. Written informed consent must be obtained prior to any procedures. For Japan only: written consent is necessary both from the patient and his/her legal representative if he/she is under the age of 20 years.
- •2. Age = 18 years
- •3. Phase I part: Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by RECIST version 1.1 (refer to Appendix 1), who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists.
- •4. Phase II part: Patients with advanced/metastatic solid tumors, with at least one measurable lesion as determined by RECIST version 1.1, who have had disease progression. Additionally, the following must apply:
- •i. Disease recurrence or progression during or after no more than one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease. Prior maintenance therapy is allowed
- •(considered pemetrexed, erlotinib, bevacizumab).
- •ii. Patients must have been tested for mutations affecting EGFR and/or ALK. (Patients with a known mutation in one gene need not be tested for the other). Patients with ALK or EGFR-positive NSCLC must have had recurrent or progressive disease after
- •treatment with the corresponding inhibitor and no more than one platinum doublet-based chemotherapy, in any sequence.
- •b. Melanoma:
- •i. Patients with BRAF V600 mutation positive disease must have objective evidence of progression of disease after treatment with a BRAF inhibitor alone or in combination with other agents.
- •ii. Patients with BRAF wild-type disease must have objective evidence of progression of disease but are not required to have received prior therapy.
- •i. Patients must have objective evidence of progression of disease during or following at least one regimen of treatment for advanced renal cancer.
- •d. Mesothelioma:
- •i. Patients must have objective evidence of progression of disease during or following at least one prior line of systemic chemotherapy for advanced disease.
- •i. Patients must have objective evidence of progression of disease during or following no more than 2 prior lines of systemic chemotherapy for advanced disease. Patients must have received a prior taxane-containing regimen.
- •5. ECOG Performance Status = 1.
- •6. Phase I Part: Patients enrolled in the Phase I part of the study must provide a new tumor biopsy at baseline and during treatment if medically feasible.
- •Phase II part: Patients enrolled in the Phase II part of the study must provide a new tumor biopsy at baseline and during treatment, if medically feasible.
- •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 276
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 140
排除标准
- •1. Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy (such as radiotherapy or
- •surgery), or increasing doses of corticosteroids within the prior 2 weeks. Patients with treated brain metastases should be neurologically stable for at
- •least 4 weeks prior to study entry and off steroids for at least 2 weeks before administration of any study treatment.
- •2. History of severe hypersensitivity reactions to study treatment ingredients or other mAbs
- •3. Patient with out-of-range laboratory values defined as:
- •Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 40 mL/min
- •Total bilirubin > 1.5 x ULN, except for patients with Gilbert’s syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN
- •Alanine aminotransferase (ALT) > 3 x ULN
- •Aspartate aminotransferase (AST) > 3 x ULN
- •Absolute neutrophil count (ANC) < 1.0 x 109/L
- •Platelet count < 75 x 109/L
- •Hemoglobin (Hgb) < 9 g/dL
- •Potassium, magnesium, calcium or phosphate abnormality CTCAE > grade 2
- •4. Clinically significant cardiac disease or impaired cardiac function
- •5. Active, known or suspected autoimmune disease. Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to an autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or other conditions not expected to recur are permitted to enroll. Patients previously exposed to anti-PD-1 / PD-L1 treatment who are adequately treated for skin rash or who are receiving replacement therapy for
- •endocrinopathies should not be excluded.
- •6. Patients who required discontinuation of treatment due to treatment-related toxicities with prior therapy directed against the same target as the drug(s) under study in this protocol.
- •7. History of drug-induced pneumonitis or current pneumonitis
- •8. Active infection requiring systemic antibiotic therapy. Patients requiring systemic antibiotics for infection must have completed therapy before screening is initiated.
- •9. HIV infection. Testing for HIV status is not necessary unless clinically indicated
- •10. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Testing for HBV or HCV status is not necessary unless clinically indicated or the patient
- •has a history of HBV or HCV infection.
- •11. Malignant disease, other than that being treated in this study
- •12. Any medical condition that would, in the investigator’s judgment, prevent the patient’s participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results.
- •For further exclusion criteria please refer to the protocol.
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