EUCTR2017-000350-19-PL进行中（未招募）1 期
An open-label, randomized, phase 3 clinical trial of REGN2810 versus investigator's choice of chemotherapy in recurrent or metastatic cervical carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 608
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •The criteria listed below are not intended to contain all considerations relevant to a patient’s potential participation in this clinical trial.
- •1. 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).
- •a.Patients with acceptable histologies (squamous carcinoma, adenocarcinoma, and adenosquamous carcinoma (AC)) will be enrolled
- •from the original protocol through protocol Amendment 4. For the purpose of this study, AC will be stratified as adenocarcinoma.
- •b. Starting with protocol Amendment 5, only patients with squamous cell histology are eligible to enroll.
- •2. Tumor progression or recurrence after treatment with platinum therapy (must have been used to treat metastatic, persistent, or recurrent cervical cancer).
- •3. Patient must have measurable disease as defined by RECIST
- •4. Eastern Cooperative Oncology Group (ECOG) performance status =1
- •5. =18 years old
- •6. Adequate organ or bone marrow function
- •7. Received prior bevacizumab therapy or had clinically documented reason why not administered
- •8. Received prior paclitaxel therapy or had clinically documented reason why not administered
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 532
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 76
排除标准
- •1. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments.
- •2. Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
- •3. Prior treatment with immune modulating agents (other than anti-PD-1/PD-L1 agents) within 28 days (within 90 days if there was an immune-related adverse event).
- •4. Active or untreated brain metastases.
- •5. Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of study drug cemiplimab or IC chemo.
- •6. Active infection requiring systemic therapy.
- •7. History of pneumonitis within the last 5 years
- •8. Documented allergic or acute hypersensitivity reaction attributed to antibody treatments
- •9. History of malignancy other than cervical cancer within 3 years of first planned dose of cemiplimab, except for tumors with negligible risk of metastasis
- •10. Prior treatment with live vaccines within 30 days of initial administration of cemiplimab. Patients must not be treated with live vaccines during the study and up to 5 half-lives following the last dose of study drug.
- •11. Patients with prior treatment on any clinical trial within 30 days of the initial administration of study drug (excepts Non-interventional and observational trials).
研究者
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