试验雷达 AI | ||
|---|---|---|
临床试验 NCT07459543 针对Untreated Melanoma，不可切除的黑色素瘤，转移性黑色素瘤目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
一个试验符合筛选条件
卡片视图
返回搜索
百时美施贵宝A Study To Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Untreated, Unresectable or Metastatic Melanoma Participants In India IV期 30
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“试验详解”即可查看和讨论您选择的语言的试验信息。
临床试验NCT07459543旨在研究治疗，主要针对Untreated Melanoma，不可切除的黑色素瘤，转移性黑色素瘤。这是一项IV期 干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2026年11月15日开始，预计招募30名患者。该研究由百时美施贵宝主导，计划于2029年5月28日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月9日。
简要概括
The purpose of this study is to assess the safety and tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) in untreated, unresectable or metastatic melanoma participants in India
官方标题
A Phase 4, Single Arm, Open Label Study to Evaluate Safety, Tolerability, and Efficacy of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) in Participants With Previously Untreated, Unresectable or Metastatic Melanoma in India.
疾病
Untreated Melanoma不可切除的黑色素瘤转移性黑色素瘤其他研究标识符
- CA224-1125
NCT编号
实际开始日期
2026-11-15
最近更新发布
2026-03-09
预计完成日期
2029-05-28
计划入组人数
30
研究类型
干预性研究
试验分期 (阶段)
IV期
试验状态
尚未招募
关键词
Skin Cancer
Malignant Melanoma
Immunotherapy
India
Nivolumab
Relatlimab
Malignant Melanoma
Immunotherapy
India
Nivolumab
Relatlimab
主要目的
治疗方法
分配方式
不适用
干预模型
单组试验
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Administration of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) | Nivolumab + Relatlimab Specified dose on specified days |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Incidence of adverse events (AEs) | Up to 30 weeks | |
Incidence of drug-related AEs | Up to 30 weeks | |
Incidence of serious adverse events (SAEs) | Up to 30 weeks | |
Incidence of drug-related SAEs | Up to 30 weeks | |
Incidence of immune-mediated adverse events (IMAEs) | Up to 30 weeks | |
AEs leading to discontinuation of treatment | Up to 30 weeks | |
Number of deaths | Up to 30 weeks | |
Number of participants with laboratory abnormalities | Up to 30 weeks |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Objective response rate (ORR) as assessed by investigator, using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to 30 weeks |
参与助手
资格标准
适龄参与研究
儿童, 成人, 老年人
最低年龄要求
12 Years
适龄性别
全部
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1/Lansky Performance Score ≥ 80% for minors (ages 12-17) ONLY.
- Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the American Joint Committee on Cancer (AJCC) staging system (8th edition).
- Participants must be treatment-naïve (ie, no prior systemic anticancer therapy for unresectable or metastatic melanoma).
- Participants must have measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
- Participants must have completed prior radiotherapy at least 2 weeks prior to study treatment administration.
- Individuals of Childbearing Potential (IOCBP) must not be pregnant or breastfeeding.
- Participants must not have active brain metastases or leptomeningeal metastases.
- Participants must not have uveal melanoma.
- Participants must not have an active, known, or suspected autoimmune disease.
- Participants must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment.
- Participants must not have a history of myocarditis.
- Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways. Prior treatment with relatlimab or any other with LAG-3 targeted agents.
- Other protocol-defined Inclusion/Exclusion criteria apply.
百时美施贵宝研究中心联系人
联系人: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, 855-907-3286, [email protected]
联系人: First line of the email MUST contain NCT # and Site #.
8 位于 1 个国家/地区的研究中心
Maharashtra
Local Institution - 0009, Navi Mumbai, Maharashtra, 400614, India
Site 0009, 联系人
Local Institution - 0008, Pune, Maharashtra, 411017, India
Site 0008, 联系人
Odisha
Local Institution - 0003, Bhubaneswar, Odisha, 751007, India
Site 0003, 联系人
Local Institution - 0002, Chennai, 600006, India
Site 0002, 联系人
Local Institution - 0006, Mumbai, 400 012, India
Site 0006, 联系人
Local Institution - 0005, Nagpur, 440001, India
Site 0005, 联系人
Local Institution - 0004, New Delhi, 110029, India
Site 0004, 联系人
Local Institution - 0001, New Delhi, 110085, India
Site 0001, 联系人