2022-501966-23-00招募中3 期
Adjuvant Therapy with Pembrolizumab versus Placebo in Resected Highrisk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE 716)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 530
- 试验地点
- 48
- 主要终点
- Recurrence-free Survival (RFS)
研究概览
简要总结
To compare Recurrence-free Survival (RFS) between treatment arms.
入排标准
- 年龄范围
- 0 years 至 65+ years（65+ Years, 18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Is 12 years or older
- •Has surgically resected and histologically/pathologically confirmed new diagnosis of Stage IIB or IIC cutaneous melanoma per American Joint Committee on Cancer (AJCC) 8th edition guidelines
- •Has not been previously treated for melanoma beyond complete surgical resection
- •Has ≤12 weeks between final surgical resection and randomization
- •Has no evidence of metastatic disease on imaging as determined by investigator
- •Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale or Lansky Play-Performance Scale (LPS) score ≥50 for participants ≤16 years old, or a Karnofsky Performance Scale (KPS) score ≥50 for participants >16 and <18 years old
- •Has recovered adequately from toxicity and/or complications from surgery prior to study start
- •Female participants must not be pregnant or breastfeeding, and must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment if they are women of childbearing potential (WOCBP)
排除标准
- •WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- •Has a known history of human immunodeficiency virus (HIV) infection
- •Has a known history of hepatitis B (defined as hepatitis B surface antigen reactive) or known active hepatitis C virus (defined as hepatitis C virus ribonucleic acid [RNA] [qualitative] is detected) infection
- •Has a history of active tuberculosis (Bacillus tuberculosis)
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
- •Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
- •Has had an allogeneic tissue/solid organ transplant
- •Has received prior therapy with an anti-Programmed Cell Death Receptor 1 (PD-1), anti-Programmed Cell Death Receptor Ligand 1 (PD-L1) or anti-Programmed Cell Death Receptor Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)
- •Has received prior systemic anti-cancer therapy for melanoma including investigational agents
- •Has received a live vaccine within 30 days prior to the first dose of study treatment
- •Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
- •Has severe hypersensitivity (≥Grade 3) to any excipients of pembrolizumab
- •Has an active autoimmune disease that has required systemic treatment in the past 2 years
- •Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
- •Has an active infection requiring systemic therapy
结局指标
主要结局
Recurrence-free Survival (RFS)
Recurrence-free Survival (RFS)
次要结局
- Distant Metastasis-free Survival (DMFS)
- Overall Survival (OS)
- Number of Participants Who Experienced at Least One Adverse Event (AE)
- Number of Participants Who Discontinued Study Treatment Due to an AE
研究者
Mizuho Kalabis
Scientific
Merck Sharp & Dohme LLC
研究点 (48)
Loading locations...
相似试验
招募中
2 期
Pembrolizumab in locally advanced sinonasal carcinoma - NeoPeSino2023-505917-25-00Istituti Clinici Scientifici Maugeri In Forma Abbreviata Istituti Clinici Scientifici Maugeri O Anche Ics Maugeri O Maugeri S.p.A. Sb28
招募中
3 期
A Phase 3 randomized clinical Study of Pembrolizumab plus epacadostat, pembrolizumab monotherapy, and the EXTREME regimen as first line treatment for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma2024-512015-47-00Incyte Corp.42
招募中
3 期
Phase 3 Study of V940 and Pembrolizumab in Resected MelanomaMelanoma2023-503652-27-00Merck Sharp & Dohme LLC596
尚未招募
2 期
Pembrolizumab + MRGOO3 as Neoadjuvant in NPCNPCNCT07267338Union Hospital, Tongji Medical College, Huazhong University of Science and Technology35
已完成
3 期
Pembrolizumab with Lenvatinib versus Docetaxel for Metastatic NSCLC after Platinum Doublet Chemotherapy and Immunotherapy2022-501439-18-00Merck Sharp & Dohme LLC206