NCT04646005已完成2 期
A Phase 2 Study of Cemiplimab, an Anti-PD-1 Monoclonal Antibody, and ISA101b Vaccine in Patients With Recurrent/Metastatic HPV16 Cervical Cancer Who Have Experienced Disease Progression After First Line Chemotherapy
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
- 113
- 试验地点
- 25
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The primary objective of the study is to estimate the clinical benefit of cemiplimab + ISA101b after progression on first line chemotherapy, as assessed by objective response rate (ORR).
The secondary objectives of the study are:
- To characterize the safety profile of cemiplimab + ISA101b
- To assess preliminary efficacy of cemiplimab + ISA101b as measured by duration of response (DOR), progression-free survival (PFS), and overall survival (OS)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adult patients ≥18 years of age (or the legal age of adults to consent to participate in a clinical study per country specific regulations).
- •Has histologically confirmed recurrent or metastatic HPV16 positive cervical cancer as determined by an investigational HPV16 PCR assay, who have experienced disease progression after treatment with platinum containing therapy as defined in the protocol
- •Patient must be determined to be positive for HPV16 genotype, as determined by a specified central reference laboratory.
- •Patient must have measurable disease as defined by RECIST 1.
- •Must have received prior bevacizumab and taxol unless meets pre-specified protocol criteria
- •ECOG performance status of 0 or
- •Has adequate organ and bone marrow function as defined in the protocol.
- •Anticipated life expectancy ≥20 weeks.
排除标准
- •Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
- •Prior treatment with other systemic immune-modulating agents as defined in the protocol
- •Major surgery or radiation therapy within 14 days of first administration of study drug
- •Has received treatment with an approved systemic therapy within 4 weeks of first dose of study drug, or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities except for laboratory changes as described in the protocol
- •Has another malignancy that is progressing or requires active treatment and/or history of malignancy other than cervical cancer within 3 years of date of first planned dose of study drug as defined in the protocol
- •Has any condition that requires ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 4 weeks prior to the first dose of study drug.
- •Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol
- •NOTE: Other protocol-defined Inclusion/ Exclusion criteria apply
研究组 & 干预措施
Cemiplimab+ISA101b
Experimental
干预措施: Cemiplimab (Drug)
Cemiplimab+ISA101b
Experimental
干预措施: ISA101b (Biological)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: From enrollment to last dose (~up to 23 months)
Objective response rate (ORR) is determined by the proportion of participants with best overall response of complete response (CR) or partial response (PR) in the Full analysis set (FAS).
次要结局
- Number of Treatment Emergent Adverse Events (TEAEs)(From enrollment to last dose (~up to 23 months))
- Number of Participants With Any Treatment Emergent Adverse Events (TEAEs)(From enrollment to last dose (~up to 23 months))
- Number of Participants With Any Treatment Emergent Adverse Events of Special Interest (TE AESIs)(From enrollment to last dose (~up to 23 months))
- Number of Participants With Any Serious TEAE(From enrollment to last dose (~up to 23 months))
- Number of Participants With at Least One Lab Abnormality(From enrollment to last dose (~up to 23 months))
- Number of Participants With at Least One Lab Abnormality With Severity of ≥ Grade 3(From enrollment to last dose (~up to 23 months))
- Duration of Response (DOR)(From enrollment to last dose (~up to 23 months))
- Progression Free Survival (PFS)(From enrollment to last dose (~up to 23 months))
- Overall Survival (OS)(From enrollment to last dose (~up to 23 months))
研究者
研究点 (25)
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