JPRN-jRCT2080223984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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi K.K.
- 入组人数
- 590
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Intervention Model: Parallel Assignment Intervention Model Description: The treatment period begins with randomization to 1 of the treatment arms. Cycle length is 6 weeks
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •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).
- •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 1.1.
- •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
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 other systemic immune-modulating agents that was (a) within fewer than 4 weeks (28 days) of the enrollment date, or (b) associated with irAEs of any grade within 90 days prior to enrollment, or (c) associated with toxicity that resulted in discontinuation of the immune modulating agent
- •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 (REGN2810 [cemiplimab] or IC chemo)
- •6. Active infection requiring therapy
- •7. History of pneumonitis within the last 5 years
- •8. History of documented allergic reactions or acute hypersensitivity reaction attributed to antibody treatments
- •9. 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 (REGN2810 [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
研究者
相似试验
进行中（未招募）
1 期
The aim of this study is to see how well an investigational drug (called BBI-608) works when it is given in combination with paclitaxel, a chemotherapy treatment, or if it is better to receive paclitaxel alone for people with advanced, previously treated lung cancer. To do so, half of the patients in this study will receive paclitaxel plus BBI-608 while the other half will receive paclitaxel alone.EUCTR2016-002718-32-ESBoston Biomedical, Inc.870
进行中（未招募）
1 期
The aim of this study is to see how well an investigational drug (called BBI-608) works when it is given in combination with paclitaxel, a chemotherapy treatment, or if it is better to receive paclitaxel alone for people with advanced, previously treated lung cancer. To do so, half of the patients in this study will receive paclitaxel plus BBI-608 while the other half will receive paclitaxel alone.Histologically or cytologically confirmed recurrent, locally advanced, or metastatic non-squamous non-small cell lung cancer.MedDRA version: 21.1Level: LLTClassification code 10066490Term: Progression of non-small cell lung cancerSystem Organ Class: 100000004864EUCTR2016-002718-32-ITBOSTON BIOMEDICAL, INC.870
进行中（未招募）
1 期
A Phase III Study of Pembrolizumab in Participants with Gastric CancerGastric or Gastroesophageal Junction AdenocarcinomaMedDRA version: 20.1Level: LLTClassification code 10017770Term: Gastric carcinomaSystem Organ Class: 100000004864EUCTR2014-005241-45-DEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.720
进行中（未招募）
1 期
A Phase III Study of Pembrolizumab in Subjects with Gastric CancerGastric or Gastroesophageal Junction AdenocarcinomaMedDRA version: 20.0Level: PTClassification code 10001150Term: Adenocarcinoma gastricSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-005241-45-PLMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.720
进行中（未招募）
1 期
A Phase III Study of Pembrolizumab in Subjects with Gastric CancerGastric or Gastroesophageal Junction AdenocarcinomaMedDRA version: 17.1Level: PTClassification code 10001150Term: Adenocarcinoma gastricSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-005241-45-ITMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.720