NCT04277663终止3 期
A Phase 3, Open-label, Multicenter Study, IBI310 in Combination With IBI308 and IBI308 Compared to High-Dose Interferon In Patients With Acral Melanoma That Has Been Removed by Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Recurrence-free survival rate
研究概览
简要总结
This is a phase III randomized, control, multi-center study of recombinant humanized anti-PD-1 mAb in combination with CTLA4 mAb for injection compared to high-Dose interferon in patients with acral melanoma that has been removed by surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign the written informed consent (Informed Consent, ICF), and be able to abide by the visits and related procedures stipulated in the plan.
- •Completely resected stage IIIB-IV acral melanoma (according to the 8th edition of AJCC staging criteria for malignant melanoma of the skin). Complete resection of stage III melanoma includes extended resection of the primary lesion and/or regional lymph node dissection and/or resection of satellite nodules. Complete resection of stage IV melanoma includes resection of primary tumor and complete resection of metastases. Complete resection of melanoma should conform to the principle of R0 resection and be confirmed by the investigator. Requirements for regional lymph node dissection refer to: upper extremity melanoma, at least 10 lymph nodes in the draining lymph node area; lower extremity melanoma, at least 5 lymph nodes in the draining lymph node area. In special cases, such as ① the long diameter of lymph nodes is ≥ 3 cm, it is considered that the number of lymph nodes can not be resected because of lymph node fusion; ② the draining lymph node area that needs to be cleaned only includes the cubital fossa or popliteal fossa, and the number of lymph nodes is difficult to reach 5-10, etc., it needs to be studied The patient confirmed whether the lymph node dissection was in line with R0 resection.
- •Stage IIIB-IV acral melanoma with histologically/cytologically confirmed primary lesions in extremities (hands, feet, subungual nails). For subjects with only metastatic lesions confirmed by histopathology, researchers need to confirm that the primary lesions are in the extremities and exclude other primary sites, and they can discuss with the medical monitors to decide whether to enroll.
- •The first study drug injection can only be carried out when the incision is completely healed after melanoma resection, and the injection time should not exceed 13 weeks after the operation (if the time limit is exceeded due to unforeseen reasons, it can be discussed with the medical supervisor decision to enroll).
- •Within 4 weeks before randomization, R0 complete resection was confirmed by physical examination and imaging examination.
- •Exclusion Criteria：
- •Mucosal-derived melanoma, ocular uveal melanoma, transitional metastasis and leptomeningeal metastasis.
- •Previously exposed to any anti-CTLA-4, anti-PD-1 or anti-PD-L1/2 antibodies.
- •Previous use of interferon. If interferon therapy was used ≥ 1 year before the first dose of study treatment, and the treatment time was ≤ 30 days or the treatment dose was ≤ 3×106IU/d, they could be enrolled.
- •Hyperthyroidism or hypothyroidism, Note: Hypothyroidism subjects with stable condition after hormone replacement therapy can be enrolled.
- •Participate in another clinical study at the same time.
排除标准
- 未提供
研究组 & 干预措施
IBI310 + IBI308
Experimental
Participants will be treated with IBI310 in combination with IBI308
干预措施: IBI310+IBI308 (Drug)
IBI308
Experimental
Participants will be treated with IBI308
干预措施: IBI308 (Drug)
high-dose recombinant interferon a-2B
Active Comparator
Participants will be treated with recombinant interferon a-2B
干预措施: High-dose recombinant interferon a-2B (Drug)
结局指标
主要结局
Recurrence-free survival rate
时间窗: up to 5 years after enrollment
to evaluate the Recurrence free survival (RFS) of the patients with acral melanoma treated by IBI310 in Combination With IBI308 and high-Dose interferon
次要结局
- Overall survival (OS)(up to 5 years after enrollment)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
The Study of JS001 Compared to High-Dose Interferon In Patients With Mucosal Melanoma That Has Been Removed by SurgeryMucosal MelanomaNCT03178123Shanghai Junshi Bioscience Co., Ltd.6
进行中（未招募）
3 期
Combination With Sintilimab and XELOX+Bevacizumab as 1st Line Therapy in RAS-mutant Metastatic Colorectal CancerColorectal Cancer Stage IVNCT05171660Second Affiliated Hospital, School of Medicine, Zhejiang University446
Unknown
3 期
Study of Chemotherapy Combination With Autologous Cell Immunotherapy in the Advanced Lung CancerIIIB/IIIC/IV Lung CancerNCT03944980Tianjin Medical University Cancer Institute and Hospital146
招募中
3 期
Study of Chemotherapy Combination With Autologous Cell Immunotherapy in the Recurrent and Metastatic Colorectal CancerColorectal CancerNCT03950154Tianjin Medical University Cancer Institute and Hospital198
已完成
1 期
Phase Ib and Phase II Studies of MK-3475 in Combination + for Renal Cell Carcinoma:Clear Cell Renal CarcinomaNCT02348008Arkadiusz Z. Dudek, MD61