NCT03444376已完成1 期
A Multi-Center, Open-label Phase Ib-II Trial of the Combination of GX-188E Vaccination and Pembrolizumab in Patients With Advanced, Non-Resectable HPV Type 16 and/or 18 Positive Cervical Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 9
- 主要终点
- DLT Evaluation for Safety and Tolerability(Part A)
研究概览
简要总结
A Multi-Center, Open-label Phase Ib-II Trial of the Combination of GX-188E Vaccination and Pembrolizumab in Patients with Advanced, Non-Resectable HPV-Positive Cervical Cancer
详细描述
This is an open-label Phase Ib-II trial to evaluate the safety and efficacy of GX-188E (IM administration using Ichor TDS-IM device) + pembrolizumab (P) in patients with advanced HPV-16+ or HPV-18+ cervical cancer.
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
- •Patients must be female and age ≥ 18 years (19 years for Korean sites)
- •Patients with histologically confirmed advanced or metastatic HPV-positive (HPV-16 or HPV-18) cervical cancer, who have disease progression after treatment with all available therapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- •Life Expectancy of at least 6 months
- •Patients must agree to provide either an archival tumor tissue sample or fresh biopsy sample for baseline biomarker tissue analyses, including staining for PD-L
- •If archival tissue is not available and the patient does not have biopsy-accessible tumor lesions, the patient will be excluded.
排除标准
- •Patient has disease that is suitable for local therapy administered with curative intent.
- •Patient has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- •Patient is expected to require any other form of antineoplastic therapy while on study; including systemic chemotherapy, radiation therapy (except for palliative purposes) biological therapy, or immunotherapy not specified in this protocol.
- •Patient has a history of active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Patients have received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) and was discontinued from that treatment due to a Grade 3 or higher immune-related Adverse Event (irAE)
- •Patients with active autoimmune disease requiring systemic immunosuppressive treatment within the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
- •Patients has had an allogeneic solid organ or allogeneic bone marrow transplant
研究组 & 干预措施
GX-188E, KEYTRUDA®
Experimental
GX-188E: 1st day of week 1,2,4,7,13,19, 46/ 2mg KEYTRUDA® : Day 1 q3 weeks/ 200mg
干预措施: GX-188E (Drug)
GX-188E, KEYTRUDA®
Experimental
GX-188E: 1st day of week 1,2,4,7,13,19, 46/ 2mg KEYTRUDA® : Day 1 q3 weeks/ 200mg
干预措施: KEYTRUDA® (Drug)
结局指标
主要结局
DLT Evaluation for Safety and Tolerability(Part A)
时间窗: within 21days
Patient will be evaluated for the first 21 days for dose-limiting toxicities.
ORR for Efficacy (Part B&C)
时间窗: within 24 weeks
ORR within 24 weeks (ORR24) evaluated by RECIST v1.1
次要结局
- ORR for Efficacy (Part A)(within 24 weeks)
- Time-to-Best Response(up to 1 year)
- Overall Survival (OS)(up to 1 year)
- BORR (Part B&C)(up to 1 year)
- Progression-Free Survival (PFS)(up to 6 months)
- Duration of Response (DOR)(up to 1 year)
研究者
研究点 (9)
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