JPRN-jRCT2051230147招募中2 期
A phase 2 study to evaluate patient reported preference for subcutaneous pembrolizumab coformulated with hyaluronidase MK-3475A over intravenous pembrolizumab formulation in participants with multiple tumor types MK-3475A F11
Koh Yasuhiro0 个研究点目标入组 5 人开始时间: 2023年12月19日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 5
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Has a histologically- or cytologically-confirmed early stage or advanced/ metastatic solid tumor by pathology report and meet the following conditions based on tumor type:
- •- Surgically resected Stage IIB and IIC (pathological or clinical), or III cutaneous melanoma per American Joint Committee on Cancer (AJCC) eighth edition.
- •- Surgically resected renal cell carcinoma (RCC) with intermediate-high or high risk of recurrence as defined by the Fuhrman grading status.
- •- Stage IV non-small cell lung cancer (NSCLC) per AJCC eight edition, with an anti-programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) >=50% determined using the Dako PD-L1 immunohistochemistry (IHC) 22C3 pharmDx diagnostic kit, and confirmation that epidermal growth factor receptor (EGFR-), anaplastic lymphoma kinase (ALK-), or c-ros oncogene 1 (ROS1)- directed therapy is not indicated as primary therapy.
- •- Has a life expectancy of at least 3 months.
- •- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART).
- •- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load before randomization.
- •- Participants with history of hepatitis C virus (HCV) infection are eligible if have completed curative antiviral therapy at least 4 weeks before randomization and HCV viral load is undetectable at screening.
- •- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 3 days before the start of study intervention.
排除标准
- •- Non-small cell lung cancer (NSCLC) participants with a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
- •- Melanoma participants with ocular, mucosal, or conjunctival melanoma.
- •- Renal Cell Carcinoma (RCC) participants who have had major surgery, other than nephrectomy, within 12 weeks before randomization.
- •- Has received prior radiotherapy for RCC.
- •- RCC participants who have residual thrombus post nephrectomy in the vena renalis or vena cava.
- •- Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137).
- •- Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
- •- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
- •-Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids.
- •- Received prior systemic anticancer therapy for their metastatic NSCLC.
- •Note: Prior treatment with neoadjuvant or adjuvant therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.
- •- Received radiation therapy to the lung that is >30 Gray within 6 months of start of study intervention.
- •- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
- •- Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication.
- •- Has known additional malignancy that is progressing or has required active treatment within the past 3 years.
- •- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •- Has active autoimmune disease that has required systemic treatment in the past 2 years.
- •- Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- •- Has active infection requiring systemic therapy.
- •- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- •- Has history of allogeneic tissue/solid organ transplant corticosteroids.
- •- Has severe hypersensitivity (>=Grade 3) to pembrolizumab and/or any of its excipients.
- •- Has not adequately recovered from major surgery or have ongoing surgical complications.
研究者
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