NCT07459543尚未招募4 期
A Phase 4, Single Arm, Open Label Study to Evaluate Safety, Tolerability, and Efficacy of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) in Participants With Unresectable or Metastatic Melanoma in India.
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 11
- 主要终点
- Incidence of adverse events (AEs)
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) in unresectable or metastatic melanoma participants in India.
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
- •- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1/Lansky Performance Score ≥ 80% for minors (ages 12-17) ONLY.
- •Note: Participants with ECOG PS 2 are allowed if the performance status of 2 is attributable to disease burden (and not to significant comorbidity), and if the investigator and Medical Monitor agree the patient may benefit from treatment.
- •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 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.
排除标准
- •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.
- •Note: Participants may enroll with the following conditions:
- •i) type 1 diabetes mellitus; ii) hypothyroidism only requiring hormone replacement; iii) skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment; iv) conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- •- 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.
- •Note: Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- •Participants must not have a history of myocarditis.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Administration of Nivolumab + Relatlimab Fixed-Dose Combination (FDC)
Experimental
干预措施: Nivolumab + Relatlimab (Drug)
结局指标
主要结局
Incidence of adverse events (AEs)
时间窗: Up to 30 weeks
Incidence of drug-related AEs
时间窗: Up to 30 weeks
Incidence of serious adverse events (SAEs)
时间窗: Up to 30 weeks
Incidence of drug-related SAEs
时间窗: Up to 30 weeks
Incidence of immune-mediated adverse events (IMAEs)
时间窗: Up to 30 weeks
AEs leading to discontinuation of treatment
时间窗: Up to 30 weeks
Number of deaths
时间窗: Up to 30 weeks
Number of participants with laboratory abnormalities
时间窗: Up to 30 weeks
次要结局
- Objective response rate (ORR) as assessed by investigator, using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1(Up to 30 weeks)
研究者
研究点 (11)
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