Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination with Pembrolizumab Versus Investigator’s Choice in HLA-A*02:01-positive Participants with Previously Treated Advanced Melanoma (TEBE-AM) - IMCgp100-203

Immunocore Limited0 个研究点目标入组 150 人开始时间: 2023年4月1日最近更新: 2024年7月22日

试验速览

阶段: 1 期
状态: 招募中
发起方: Immunocore Limited
入组人数: 150

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 65+（—）
性别: All

入选标准

•18 years of age or older, HLA-A*02:01-positive, Unresectable Stage III or Stage IV non-ocular melanoma, A newly obtained (preferred) or archival tumor tissue sample has been provided, Either measurable or non-measurable disease per RECIST v1.1, ECOG performance status score of 0 or 1, Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of contraception, Participants must be capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the ICF and in the protocol., Participants must agree to provide all necessary samples for biomarker analysis

排除标准

•Diagnosis of ocular or metastatic uveal melanoma, Known psychiatric or substance abuse disorders, History (within the last year) of substance abuse (including alcohol), Pregnant or lactating women, Prior treatment with a licensed or investigative Immune-mobilizing monoclonal T cell receptor Against Cancer (ImmTAC) medication, Non adequate washout from prior medications, Ongoing Common Terminology Criteria for Adverse Events (CTCAE) Grade = 2 clinically significant AEs due to prior cancer therapeutics, Systemic treatment with steroids or any other immunosuppressive drug within 2 weeks of the planned first dose of study intervention (with exceptions), Participants who have not received required prior anticancer therapies: a.All participants must have received at least 2 doses of an approved anti-PD(L)1 mAb: i.The anti-PD(L)1 mAb may have been administered as monotherapy or in combination with another checkpoint inhibitor or other therapies, ii.The anti-PD(L)1 mAb may have been administered in the adjuvant setting or for treatment of unresectable / metastatic disease, iii.All participants must have documented disease progression, according to RECIST v1.1, during treatment or within 6 months of the last dose of an anti-PD(L)1 mAb b.All participants must have received prior treatment with ipilimumab, which may have been a part of an anti-PD(L)1 regimen or as monotherapy. C.Participants with an activating BRAF V600 mutation must have received a prior BRAF/MEK inhibitor regimen, History of tuberculosis or human immunodeficiency virus (HIV) infection, History of chronic viral infections, History of a malignant disease other than those being treated in this study (with exceptions), Out-of-range screening laboratory values, History of allogenic tissue/solid organ transplant, Ineligible to be retreated with pembrolizumab due to a treatment-related AE while on a prior anti-PD(L)1 regimen, Known untreated or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis, Previous severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb), Clinically significant pulmonary disease or impaired lung function, Clinically significant cardiac disease or impaired cardiac function, Active autoimmune disease requiring immunosuppressive treatment within 2 years of screening, Any medical condition that is poorly controlled or that would, in the Investigator’s or Sponsor’s judgment, adversely impact the participant’s participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results

研究者

发起方

Immunocore Limited

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