NCT04609566已完成2 期
A Phase 2 Study of Brentuximab Vedotin in Combination With Pembrolizumab in Participants With Metastatic Solid Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 116
- 主要终点
- Confirmed objective response rate (ORR) based on investigator assessment using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria
研究概览
简要总结
This trial will find out whether brentuximab vedotin and pembrolizumab work together to treat different types of cancer. There will be several different types of cancer studied in the trial. The cancer must have spread to other parts of the body (metastatic).
The study will also find out what side effects occur. A side effect is anything the treatment does besides treat cancer.
This is a multi-cohort study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have
- •Metastatic squamous or nonsquamous non-small cell lung cancer (NSCLC) (without known targetable EGFR, ALK, ROS1, or BRAF mutations) who either
- •a) have not yet received frontline therapy for metastatic disease and without prior exposure to anti PD-1/PD-L1 or
- •b) are relapsed/refractory with progression on anti PD-1/PD therapy.
- •Relapsed/refractory metastatic cutaneous melanoma (regardless of mutation status) with progression on a PD-1 inhibitor
- •Metastatic head and neck squamous cell carcinoma (HNSCC) who have not yet received frontline therapy for metastatic disease and without prior exposure to a PD-1/PD-L1 inhibitor.
- •Cohorts 1-4 only: Melanoma participants must be currently on PD-1 checkpoint inhibitor (CPI) therapy (e.g. nivolumab or pembrolizumab) or had their last dose of PD-1 CPI containing therapy as the last previous line of therapy within 90 days prior to enrollment; PD-1 CPI therapy must be the immediate prior line of treatment.
- •Cohorts 1-4 only: Participants must have progressed on treatment with an anti-PD-1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other CPIs or other therapies. PD-1 treatment progression is defined by meeting all of the following criteria.
- •Have received at least 2 doses of an approved PD-1 inhibitor.
- •Have demonstrated disease progression (PD) after a PD-1 inhibitor as defined by RECIST v1.
- •Progressive disease has been documented within 90 days from the last dose of PD-1 inhibitor.
- •Participants with melanoma will need iRECIST confirmation of progression with a second assessment at least four weeks after the initial date of progressive disease
- •NSCLC participants on PD-1 inhibitor containing therapy for less than 90 days will need iRECIST confirmation of progression at least 4 weeks after the initial date of progressive disease
- •Tumor tissue sample obtained within 3 months prior to enrollment is required, and no systemic anticancer therapy given after the sample was obtained.
- •An Eastern Cooperative Oncology Group (ECOG) Performance Status score of equal or less than 1
排除标准
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Prior immunosuppressive chemotherapy, any immunotherapy other than a PD-1 inhibitor within 4 weeks of first study drug dose.
- •History of another malignancy within 3 years before the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy.
研究组 & 干预措施
Combination Therapy
Experimental
brentuximab vedotin + pembrolizumab
干预措施: brentuximab vedotin (Drug)
Combination Therapy
Experimental
brentuximab vedotin + pembrolizumab
干预措施: pembrolizumab (Drug)
结局指标
主要结局
Confirmed objective response rate (ORR) based on investigator assessment using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria
时间窗: Up to approximately 2 years
Confirmed ORR per RECIST v1.1 is defined as the proportion of participants whose best overall response is a confirmed complete response (CR) or partial response (PR) per RECIST v1.1.
次要结局
- Duration of response (DOR) based on investigator assessment using RECIST v1.1 criteria(Up to approximately 3 years)
- Progression-free survival (PFS) based on investigator assessment using RECIST v1.1 criteria(Up to approximately 3 years)
- ORR per iRECIST by investigator assessment(Up to approximately 2 years)
- iDOR per iRECIST by investigator assessment(Up to approximately 3 years)
- iPFS per iRECIST by investigator assessment(Up to approximately 3 years)
- Incidence of adverse events (AEs)(Up to approximately 2 years)
研究者
研究点 (116)
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