NL-OMON50729已完成3 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) - 20110265 MASTERKEY
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 15
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Male or female age >= 18 years with histologically confirmed diagnosis of
- •melanoma and stage IIIB to IVM1c for whom surgery is not recommended. Subjects
- •must have measurable disease and be a candidate for intralesional therapy
- •administration into cutaneous, subcutaneous, or nodal lesions. Subjects must
- •have ECOG performance status of 0 or 1, and adequate hematologic, hepatic,
- •renal, and coagulation function.
- •Subjects with serine/threonine protein kinase B-Raf 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
- •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
- •Subjects (BRAF mutant, wildtype and UNK) who received prior adjuvant therapy
- •for melanoma will not be excluded 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 enrollment.
- •Subjects must have a tumor sample (archival sample or newly obtained biopsy)
- •that is adequate for PD-L1 assessment prior to randomization.
排除标准
- •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 enrollment.
- •Carcinomatous meningitis is excluded regardless of clinical stability
- •Subjects must not have primary uveal or mucosal melanoma, history or evidence
- •of melanoma associated with immunodeficiency states or history of other
- •malignancy within the past 3 years with the exceptions of the prior
- •malignancies noted in Section 4.1.3.
- •Subjects may not have been previously treated with T-VEC, 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 is allowed only in the adjuvant
- •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 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 and must not require intermittent or chronic treatment with
- •an antiherpetic drug, other than intermittent topical use.
- •For a full list of eligibility criteria please refer to Section 4.1.
研究者
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