2023-503615-14-00进行中（未招募）3 期
A Phase 2 Randomized Clinical Study of MK-4280A (coformulated favezelimab [MK-4280] plus pembrolizumab [MK-3475]) Versus Physician’s Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (KEYFORM-008)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 68
- 试验地点
- 33
- 主要终点
- Progression-Free Survival (PFS) per Lugano Response Criteria as Assessed by Investigator
研究概览
简要总结
To compare MK-4280A to physician’s choice chemotherapy with respect to PFS per Lugano response criteria by investigator assessment
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Has histologically confirmed diagnosis of classical Hodgkin lymphoma (cHL) that is 2-fluorodeoxyglucose-avid (FDG-avid).
- •Has relapsed (defined as disease progression after most recent therapy) or refractory (defined as failed to achieve CR or PR to most recent therapy) cHL and exhausted all available treatment options with known clinical benefit
- •Has progressed on treatment with an anti-PD-(L)1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies
- •Submits an archival (≤5 years) or newly obtained tumor tissue sample which has not been previously irradiated.
排除标准
- •Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy.
- •Received prior radiotherapy within 2 weeks of start of study intervention or radiation related toxicities requiring corticosteroids.
- •Has not adequately recovered from major surgical procedure.
- •Known additional malignancy that is progressing or has required active treatment within the past 3 years.
- •History of human immunodeficiency virus (HIV).
- •Has had an allogeneic hematopoietic stem cell or solid organ transplantation within the last 5 years.
- •History of central nervous system (CNS) metastases or active CNS involvement.
- •Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy.
- •History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- •Has an active infection requiring systemic treatment.
- •History of hemophagocytic lymphohisticytosis.
- •Has an active seizure disorder that is not well controlled.
- •Has clinically significant (ie, active) cardiovascular disease.
- •Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
结局指标
主要结局
Progression-Free Survival (PFS) per Lugano Response Criteria as Assessed by Investigator
Progression-Free Survival (PFS) per Lugano Response Criteria as Assessed by Investigator
次要结局
- Overall Survival (OS)
- Objective Response Rate (ORR) per Lugano Response Criteria as Assessed by Investigator
- Duration of Response (DOR) per Lugano Response Criteria as Assessed by Investigator
- Number of Participants Who Experienced At Least One Adverse Event (AE)
- Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
研究者
Pallavi Madhusoodhan Pillai
Scientific
Merck Sharp & Dohme LLC
研究点 (33)
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