NCT03257267已完成3 期
An Open-Label, Randomized, Phase 3 Clinical Trial of REGN2810 Versus Investigator's Choice of Chemotherapy in Recurrent or Metastatic Cervical Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 608
- 试验地点
- 104
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The primary objective is to compare overall survival (OS) for patients with recurrent or metastatic cervical cancer who have histology of squamous cell carcinoma (SCC) and who have any eligible histology treated with either cemiplimab or investigator's choice (IC) chemotherapy.
The secondary objectives performed among SCC patients and among all eligible histologies (SCC and adenocarcinoma/adenosquamous carcinoma (AC) are:
- To compare progression-free survival (PFS) of cemiplimab versus IC chemotherapy
- To compare objective response rate (ORR) (partial response [PR] + complete response [CR]) of cemiplimab versus IC chemotherapy per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- To compare the duration of response (DOR) of cemiplimab versus IC chemotherapy
- To compare the safety profiles of cemiplimab versus IC chemotherapy by describing adverse events (AE)
- To compare quality of life (QOL) for patients treated with cemiplimab versus IC chemotherapy using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Recurrent, persistent, and/or metastatic cervical cancer with squamous cell histology, for which there is not a curative-intent option (surgery or radiation therapy with or without chemotherapy).
- •Acceptable histologies (squamous carcinoma, adenocarcinoma, and adenosquamous carcinoma) as defined in the protocol
- •Tumor progression or recurrence after treatment with platinum therapy (must have been used to treat metastatic, persistent, or recurrent cervical cancer)
- •Patient must have measurable disease as defined by RECIST 1.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- •≥18 years old
- •Adequate organ or bone marrow function
- •Received prior bevacizumab therapy or had clinically documented reason why not administered
- •Received prior paclitaxel therapy or had clinically documented reason why not administered
排除标准
- •Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
- •Prior treatment with an agent that blocks the PD-1/PD-L1 pathway
- •Prior treatment with other systemic immune-modulating agents that was
- •within fewer than 4 weeks (28 days) of the enrollment date, or
- •associated with irAEs of any grade within 90 days prior to enrollment, or
- •associated with toxicity that resulted in discontinuation of the immune modulating agent
- •Active or untreated brain metastases
- •Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of study drug cemiplimab or IC chemo)
- •Active infection requiring therapy
- •History of pneumonitis within the last 5 years
- •History of documented allergic reactions or acute hypersensitivity reaction attributed to antibody treatments
- •Concurrent malignancy other than cervical cancer and/or history of malignancy other than cervical cancer within 3 years of date of first planned dose of study drug cemiplimab or IC chemo), except for tumors with negligible risk of metastasis or death, such as adequately treated cutaneous squamous cell carcinoma or basal cell carcinoma of the skin or ductal carcinoma in situ of the breast. Patients with hematologic malignancies (eg, chronic lymphocytic leukemia) are excluded.
- •Note: Other protocol defined Inclusion/Exclusion apply
研究组 & 干预措施
Experimental Therapy
Experimental
Cemiplimab
干预措施: Cemiplimab (Drug)
Control Therapy
Active Comparator
Investigator choice (IC) chemotherapy
干预措施: Investigator Choice (IC) Chemotherapy (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: From first dose up to 90 following last dose (~42 months)
Overall survival was defined as the time from randomization to the date of death due to any cause. A participant who had not died was censored at the last known date of contact.
Overall Survival (OS) in the SCC Population
时间窗: From first dose up to 90 following last dose (~42 months)
Overall survival was defined as the time from randomization to the date of death due to any cause. A participant who had not died was censored at the last known date of contact.
次要结局
- Progression-free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)(Time from randomization to the date of the first documented tumor progression or death due to any cause (assessed up to 40 months))
- Objective Response Rate (ORR) Assessed by Investigator Using RECIST 1.1(From date of randomization up to 40 months)
- Duration of Response (DOR) Assessed Per RECIST 1.1(Time from the date of first response to the date of the first documented progressive disease or death due to any cause (up to 40 months))
- Quality of Life (QoL): Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) of Global Health Status /Quality of Life (GHS/QoL) and Physical Functioning Scales(From Cycle 1 Day 1 up to 40 months (Each cycle = 42 days))
- Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death(From first dose up to 90 following last dose (~36 months))
- Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade(From first dose up to 90 following last dose (~36 months))
研究者
研究点 (104)
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