Single-Arm Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Recurrent Metastatic Nasopharyngeal Carcinoma Systemic Treatment Naïve Participants
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 22
- 主要终点
- Objective Response Rate (ORR) assessed by a Blinded Independent Central Review (BICR) Committee according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
研究概览
简要总结
This study aims to investigate toripalimab with chemotherapy in participants with nasopharyngeal cancer.
详细描述
The primary objective of this study is to evaluate the efficacy of toripalimab in combination with chemotherapy (cisplatin and gemcitabine), as measured by objective response rate (ORR) assessed by a Blinded Independent Central Review Committee (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in first-line recurrent metastatic nasopharyngeal cancer participants (both Epstein-Barr virus (EBV) and non-EBV-associated).
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological confirmation of recurrent/metastatic nasopharyngeal cancer with either EBV or non-EBV-associated cancer. The following subgroups are included:
- •EBER/EBV-negative (HPV+/-)
- •EBER/EBV-positive (HPV+/-)
- •Recurrent/metastatic (stage IV-B as defined by the International Union against Cancer [UICC] and American Joint Committee on Cancer [AJCC] staging system for nasopharyngeal cancer [NPC], eighth edition) or recurrent NPC after curative treatment. For recurrent NPC, more than 6 months between the last dose of radiotherapy or chemotherapy and the date of recurrence.
- •Measurable disease based on RECIST v 1.1 as determined by the site. Note: Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
排除标准
- •Disease that is suitable for local therapy administered with curative intent.
- •Prior systemic therapy administered in the recurrent or metastatic setting. Participants who develop disease recurrence within 6 months from curative intent chemoradiation will be excluded.
- •Rapidly progressing disease (e.g., tumor bleeding, uncontrolled tumor pain) in the opinion of the treating investigator.
- •Active or untreated central nervous system (CNS) metastases (e.g., brain or leptomeningeal), as determined on computerized tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments. Participants who have prior therapies for brain or leptomeningeal metastasis and have been stabilized ≥ 1 month and have discontinued systemic steroid therapy (>10 mg/day prednisone or equivalent) ≥ 1 month prior to enrollment are eligible.
- •Other protocol-defined inclusion and exclusion criteria apply.
研究组 & 干预措施
Toripalimab + cisplatin (or carboplatin) + gemcitabine
Participants will receive the triple combination of cisplatin, gemcitabine and toripalimab (Chemotherapy-based treatment phase) followed by single-agent toripalimab (Maintenance treatment phase). The use of cisplatin can be substituted with carboplatin from cycle 2 onwards.
干预措施: Toripalimab (Drug)
Toripalimab + cisplatin (or carboplatin) + gemcitabine
Participants will receive the triple combination of cisplatin, gemcitabine and toripalimab (Chemotherapy-based treatment phase) followed by single-agent toripalimab (Maintenance treatment phase). The use of cisplatin can be substituted with carboplatin from cycle 2 onwards.
干预措施: Carboplatin (Drug)
Toripalimab + cisplatin (or carboplatin) + gemcitabine
Participants will receive the triple combination of cisplatin, gemcitabine and toripalimab (Chemotherapy-based treatment phase) followed by single-agent toripalimab (Maintenance treatment phase). The use of cisplatin can be substituted with carboplatin from cycle 2 onwards.
干预措施: Cisplatin (Drug)
Toripalimab + cisplatin (or carboplatin) + gemcitabine
Participants will receive the triple combination of cisplatin, gemcitabine and toripalimab (Chemotherapy-based treatment phase) followed by single-agent toripalimab (Maintenance treatment phase). The use of cisplatin can be substituted with carboplatin from cycle 2 onwards.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Objective Response Rate (ORR) assessed by a Blinded Independent Central Review (BICR) Committee according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
时间窗: Up to 24 months
次要结局
- DoR assessed by the investigator according to RECIST v1.1(Up to 24 months)
- Duration of Response (DoR) assessed by BICR according to RECIST v1.1(Up to 24 months)
- ORR assessed by the investigator according to RECIST v1.1(Up to 24 months)
- PFS assessed by the investigator according to RECIST v1.1(Up to 24 months)
- Overall Survival (OS) defined as time from enrollment to death due to any cause(Up to 42 months)
- Progression-free Survival (PFS) assessed by BICR according to RECIST v1.1(Up to 24 months)
- Landmark PFS rates at 1 year and 2 years, derived from Kaplan-Meier (KM) curve(12 months, 24 months)
- Disease Control Rate (DCR) assessed by BICR according to RECIST v1.1(Up to 24 months)
- DCR assessed by the investigator according to RECIST v1.1(Up to 24 months)