NL-OMON45831已完成3 期
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Pembrolizumab (MK-3475) in Combination With Epacadostat or Placebo in Subjects with Unresectable or Metastatic Melanoma (KEYNOTE-252 / ECHO-301). - MK3475-252
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 14
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
- •- Have histologically or cytologically confirmed melanoma.
- •- Have unresectable Stage III or Stage IV melanoma, not amenable to local therapy.
- •- Have been untreated for advanced or metastatic disease - with exceptions as outlined in the protocol.
- •- Have documentation of V600-activating BRAF mutation status or consent to BRAF V600 mutation testing during the screening period.
- •- Have laboratory parameters within Protocol-defined range.
- •- Have the presence of at least one measurable lesion by CT or MRI per RECIST 1.1 criteria.
- •- Provide a baseline tumor biopsy
- •- Have resolution of toxic effect(s) of the most recent prior therapy to Grade 1 or less (except alopecia).
- •- Have an Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
排除标准
- •- Has received prior systemic treatment for unresectable or metastatic melanoma (except therapy as noted in inclusion criteria #3).
- •- Has received prior therapy with an anti*PD-1, anti*PD-L1, anti*PD-L2, anti*CD137, or IDO1 inhibitor or any other antibody or drug specifically targeting checkpoint pathways other than anti-CTLA-4 which is permitted in the adjuvant setting.
- •- Has received prior adjuvant therapy, monoclonal antibody, chemotherapy or an investigational agent or device within 4 weeks or 5 half-lives (whichever is longer) before administration of study drug or not recovered (* Grade 1 or at baseline) from AEs due to previously administered agents. Exception to this rule would be use of denosumab, which is not excluded.
- •Note: Subjects with * Grade 2 neuropathy are an exception and may enroll.
- •- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment.
- •- Has a known additional malignancy that is progressing or requires active treatment. Exceptions are described in the protocol.
- •- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •- Has ocular melanoma.
- •- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- •- Has an active infection requiring systemic therapy.
- •- Has known history of human immunodeficiency virus (HIV)
- •- Has known history of or is positive for Hepatitis B or Hepatitis C
- •- Has history of (noninfectious) pneumonitis that required steroids, or current pneumonitis.
- •- Has received prior radiotherapy within 2 weeks of therapy. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
- •- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study.
- •- Has received live vaccine within 30 days before the first dose of study treatment.
- •- Has received monoamine oxidase inhibitors within the 21 days prior to starting study treatment.
- •- Has any history of Serotonin Syndrome after receiving serotonergic drugs.
- •- Has presence of a gastrointestinal condition that may affect drug absorption.
- •- Has a history or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful.
- •- Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, New York Heart Association Class III or IV congestive heart failure, and arrhythmia requiring therapy. Medically controlled arrhythmia would be permitted.
研究者
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