NL-OMON44956已完成3 期
A Multicenter, Randomized, Controlled, Three-Arm, Phase III Study to Evaluate the Safety and Efficacy of Two Dosing Schedules of Pembrolizumab (MK-3475) Compared to Ipilimumab in Patients with Advanced Melanoma - MK3475-006
Merck Sharp & Dohme (MSD)0 个研究点目标入组 18 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
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 99（—）
入选标准
- •Patient must have a histologically confirmed diagnosis of unresectable stage III or
- •metastatic MEL not amenable to local therapy.
- •* Patient may not have a diagnosis of uveal or ocular melanoma.;* Patients who have not received prior systemic treatment (excluding adjuvant or
- •neoadjuvant therapy) for MEL (first line) or who have received one prior systemic
- •treatment (excluding adjuvant or neoadjuvant therapy) for MEL (second line) are
- •both eligible. However, the enrollment of either first line or second line patients will
- •be limited to approximately 387 patients (60% of the total patients). After this limit is
- •reached for either of the groups, only patients from the other group will be enrolled.;* Patients must have testing for a BRAF mutation prior to study entry. Patients with
- •BRAF V600E mutant melanoma may have received prior BRAF inhibitor therapy as
- •first-line systemic therapy and be eligible for this study as second line treatment. At
- •the discretion of the investigator, patients with BRAF V600E mutant melanoma who
- •have NOT received a BRAF inhibitor are also eligible for this study as first line
- •treatment if they meet the following additional criteria:
- •* LDH < local ULN
- •* No clinically significant tumor related symptoms in the judgment of the investigator
- •* Absence of rapidly progressing metastatic melanoma in the judgment of the investigator;2)
- •Patient is male or female and *18 years of age on day of signing informed
- •consent, either by the patient or a parent or legal guardian.;3)
- •Patient must have a performance status of 0 or 1 on the Eastern Cooperative
- •Oncology Group (ECOG) Performance Scale (Appendix 6.4).;4)
- •Patient must have adequate organ function as indicated by the protocol.;5)
- •Patient has a tumor sample (archival or newly obtained biopsy) that is adequate for
- •PD-L1 assessment prior to randomization. Patients must submit the tumor sample
- •during screening for PD-L1 expression testing at a central pathology laboratory.
- •Patients will be eligible to participate regardless of the level of PD-L1 expression, but
- •will be stratified by PD-L1 expression level (high or low PD-L1 expression level) at
- •the time of randomization. Patients who do not submit a sample adequate for PD-L1
- •determination will not be randomized. Patients with an inadequate archival sample
- •may obtain a new biopsy and patients with an inadequate newly obtained biopsy may
- •undergo re biopsy at the discretion of the investigator.;6)
- •Female patient of childbearing potential has a negative urine or serum pregnancy test.
- •If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test
- •will be required. The serum pregnancy test must be negative for the patient to be
- •eligible.;7)
- •Female patients enrolled in the study, who are not free from menses for >18 months,
- •post hysterectomy/oophorectomy, or surgically sterilized, must be willing to use
- •either 2 adequate barrier methods or a barrier method plus a hormonal method of
- •contraception to prevent pregnancy or to abstain from heterosexual activity
- •throughout the study, starting with Visit 1 through 120 days after the last dose of
- •study therapy. Approved contraceptive methods include 2 of the following barrier
- •methods or one barrier method combined with a hormonal contraceptive: intra uterine
- •device, diaphragm with spermicide, cervi
排除标准
- •Patient had prior treatment with IPI or other anti-CTLA-4 agent, any anti-PD-1,
- •anti-PD-L1, or anti- PD-L2 agent.;2)
- •Patient who has had chemotherapy, radioactive, or biological cancer therapy
- •within four weeks prior to the first dose of study drug, or who has not recovered
- •to CTCAE Grade 1 or better from the AEs due to cancer therapeutics
- •administered more than four weeks earlier.;3)
- •Patient is currently participating or has participated in a study of an
- •investigational agent or using an investigational device within 30 days of the first
- •dose of study drug.;4)
- •Patient is expected to require any other form of systemic or localized
- •antineoplastic therapy while on study.;5)
- •Patient is on any systemic corticosteroid therapy within one week before the
- •planned date for first dose of randomized treatment or on any other form of
- •immunosuppressive medication.;6)
- •Patient has a history of a malignancy (other than the disease under treatment in
- •the study) within 5 years prior to first study drug administration. This should
- •exclude adequately treated Stage 1 or Stage 2 basal/squamous cell carcinoma of
- •the skin, carcinoma in situ of the cervix or breast, or other in situ cancers. Shorter
- •intervals can be considered after discussion with Sponsor.;7)
- •Patient has known active central nervous system (CNS) metastases and/or
- •carcinomatous meningitis. Patients with previously treated brain metastases may
- •participate provided they are stable (without evidence of progression by MRI for
- •at least four weeks prior to the first dose of study drug), have no evidence of new
- •or enlarging brain metastases and are off systemic steroids for at least two weeks.;8)
- •Patient previously had a severe hypersensitivity reaction to treatment with another
研究者
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