2022-501615-14-00已完成2 期
Phase 2 Study of Pembrolizumab and Chemotherapy in Patients With Newly Diagnosed Classical Hodgkin Lymphoma (KEYNOTE-C11)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 13
- 主要终点
- Complete Response (CR) at the End of Study Intervention as Assessed by Independent Central Review Per Lugano 2014 Response Criteria
研究概览
简要总结
To evaluate complete response (CR) rate at the end of study intervention in participants with newly diagnosed classical Hodgkin Lymphoma (cHL) assessed by independent central review according to Lugano 2014 response criteria
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Has a histologically confirmed diagnosis of Ann Arbor Stage III or IV classical Hodgkin Lymphoma (cHL). Stage I and II participants may be enrolled, but must have at least one National Comprehensive Cancer Network (NCCN) unfavorable risk factor per protocol
- •Has measurable 2-fluorodeoxyglucose (FDG)-avid disease based on investigator assessment according to Lugano 2014 response criteria
- •Has not received prior radiation therapy, chemotherapy, immunotherapy, or other systemic therapy for the treatment of cHL before the first dose of study intervention
- •Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 assessed within 7 days before the start of study intervention
排除标准
- •Has confirmed nodular lymphocyte-predominant Hodgkin Lymphoma (HL)
- •Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- •Has a history or current evidence of pulmonary fibrosis
- •Has had an allogenic tissue/solid organ transplant
- •Has an uncontrolled intercurrent cardiovascular illness
- •Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 protein (PD-L1), or anti- programmed cell death ligand 2 protein (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
- •Has received or is expected to receive a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- •Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
- •Has a 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 a known additional malignancy that is progressing or has required active treatment within the past 5 years
- •Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis
- •Has an active autoimmune disease that has required systemic treatment in past 2 years
结局指标
主要结局
Complete Response (CR) at the End of Study Intervention as Assessed by Independent Central Review Per Lugano 2014 Response Criteria
Complete Response (CR) at the End of Study Intervention as Assessed by Independent Central Review Per Lugano 2014 Response Criteria
次要结局
- CR at the End of Study Intervention as Assessed by Investigator Per Lugano 2014 Response Criteria
- Duration of Complete Response (DurCR) as Assessed by Independent Central Review Per Lugano 2014 Response Criteria
- Positron Emission Tomography (PET) Negativity by Independent Central Review Per 2-Fluorodeoxyglucose (FDG)-PET 5-point Scale After Administration of Pembrolizumab Monotherapy
- PET Negativity by Independent Central Review Per FDG-PET 5-point Scale After Administration of Pembrolizumab Monotherapy and Chemotherapy
- Number of Participants Who Experienced an Adverse Event (AE)
- Number of Participants Who Discontinued Study Treatment Due to an AE
研究者
Akash Nahar
Scientific
Merck Sharp & Dohme LLC
研究点 (13)
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