EUCTR2014-000185-22-CZ进行中（未招募）1 期
A Phase 1b/3, Multicenter, Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresectable, Stage IIIB to IVM1c Melanoma (MASTERKEY-265)
Amgen Inc.0 个研究点目标入组 680 人开始时间: 2016年7月27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
- 680
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
- •Phase 1b and Phase 3:
- •Male or female age = 18 years with histologically confirmed diagnosis
- •of melanoma and stage IIIB to IVM1c for whom surgery in not
- •recommended.
- •Subjects must have measurable disease and be a candidate for
- •intralesional therapy administration into cutaneous, subcutaneous, or
- •nodal lesions.
- •Subjects must have Eastern Cooperative Oncology Group (ECOG)
- •performance status of 0 or 1, and adequate hematologic, hepatic, renal,
- •and coagulation function.
- •Phase 1b only:
- •Subjects enrolled in phase 1b must be treatment naïve (i.e., must not
- •have received any prior systemic anticancer treatment consisting of
- •chemotherapy, immunotherapy, or targeted therapy) given in a nonadjuvant
- •setting for unresectable stage IIIB to IVM1c melanoma.
- •Subjects who received prior adjuvant therapy for melanoma will not be
- •excluded (including, but not limited to, radiotherapy, interferon, limb
- •infusion/perfusion, or use of investigational agents in the adjuvant
- •setting) with the exception that prior adjuvant therapy with inhibitors of
- •programmed cell death 1 (PD-1) or programmed cell death ligand 1 (PDL1)
- •is not allowed. However, if the subject received adjuvant therapy,
- •subject must have completed therapy at least 3 months prior to
- •Phase 3 only:
- •Subjects enrolled in phase 3 with serine/threonine protein kinase BRaf
- •V600 (BRAFV600) wild-type tumors must not have received any
- •prior systemic anticancer treatment consisting of chemotherapy,
- •immunotherapy, or targeted therapy given in a non-adjuvant setting for
- •unresectable stage IIIB to IVM1c melanoma.
- •Subjects enrolled in phase 3 with BRAFV600 mutated tumors who have
- •received prior BRAF inhibitor therapy either alone or in combination with
- •MEK inhibitor as their only prior systemic therapy are eligible for the
- •phase 3 of this study. Subjects with BRAFV600 mutant melanoma or
- •unknown BRAFV600 mutation status who have not received a BRAF
- •inhibitor are also eligible for the phase 3 of this study as first-line
- •treatment if they meet the following criteria: lactate dehydrogenase
- •(LDH) < upper limit of normal (ULN), no clinically significant tumor
- •related symptoms, and absence of rapidly progressing metastatic
- •melanoma. Subjects (BRAF mutant, wildtype and UNK) who received
- •prior adjuvant therapy for melanoma will not be excluded (including, but
- •not limited to, interferon, ipilimumab, limb infusion/perfusion, or use of
- •investigational agents in the adjuvant setting) with the exception that
- •prior adjuvant therapy with inhibitors of PD-1 OR PD-L1 is not allowed.
- •However, if the subject received adjuvant therapy, the subject must
- •have completed therapy at least 28 days prior to enrolment.
- •Subjects must have a tumor sample (archival sample or newly
- •obtained biopsy) that is adequate for PD-L1 assessment prior to
- •randomization.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- 另有 3 项未显示
排除标准
- •Phase 1b and Phase 3:
- •Subjects must not have clinically active cerebral metastases and/or
- •carcinomatous meningitis.
- •Subjects with up to 3 cerebral metastases may be enrolled, provided
- •that all lesions have been adequately treated with stereotactic radiation
- •therapy, craniotomy, or Gamma Knife therapy, with no evidence of
- •progression, and not requiring steroids, for at least 2 months prior
- •to enrolment. Carcinomatous meningitis is excluded regardless of clinical
- •Subjects must not have primary uveal or mucosal melanoma, history or
- •evidence of melanoma associated with immunodeficiency states (e.g.,
- •hereditary immune deficiency, organ transplant, or leukemia), or history
- •of other malignancy within the past 3 years with the exceptions of the
- •prior malignancies noted in Section 4.1.2.
- •Subjects may not have been previously treated with talimogene
- •laherparepvec, any other oncolytic virus, pembrolizumab, or any other
- •inhibitor of PD-1, PD-L1, or programmed cell death ligand 2 (PD-L2).
- •Prior treatment with other immunotherapies ( e.g., anti-CD137, or
- •cytotoxic T-lymphocyte associated antigen 4 (CTLA-4) inhibitor, or any
- •other antibody or drug specifically targeting T-cell co-stimulation or
- •checkpoint pathways), is allowed only in the adjuvant setting.
- •Subjects must not have history or evidence of symptomatic
- •autoimmune glomerulonephritis, vasculitis, other symptomatic
- •autoimmune disease, documented history of autoimmune disease or
- •syndrome requiring systemic treatment in the past 2 years (ie, with use
- •of disease modifying agents, steroids or immunosuppressive agents)
- •except vitiligo or resolved childhood asthma/atopy, or evidence of
- •clinically significant immunosuppression.
- •Subjects must not have active herpetic skin lesions or prior
- •complications of herpetic infection (eg, herpetic keratitis or encephalitis)
- •and must not require intermittent or chronic treatment with an
- •antiherpetic drug (eg, acyclovir), other than intermittent topical use.
研究者
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