2022-500967-11-00招募中3 期
A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants with Previously Untreated Metastatic or Unresectable Melanoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 423
- 试验地点
- 76
- 主要终点
- Co-Primary: The amount of study drug in your body when given SC is not worse than IV for both nivolumab and relatlimab.
研究概览
简要总结
The primary objective of this study is to assess whether the amount of study drug (both nivolumab and relatlimab) in your body when given under the skin (subcutaneously) is not different compared to study drug given directly into a vein (intravenously).
入排标准
- 年龄范围
- 0 years 至 65+ years（18-64 Years, 65+ Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 12 years of age. If age ≥12 to <18 years, must weigh ≥ 40 kg
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1/Lansky Performance Score ≥ 80% (if age ≥ 12 to < 18 years). The Performance Status/Score describes the patient’s ability to care for themselves, perform daily physical activities (eg, walking, working).
- •Confirmed Stage III (unresectable/unable to remove with surgery) or Stage IV (metastatic/spread to other parts of the body) melanoma, per American Joint Committee on Cancer (AJCC) staging system (8th edition)
- •Treatment-naive (ie, no prior systemic anticancer therapy) except for select prior adjuvant or neoadjuvant melanoma therapies if all related adverse events have returned to baseline or stabilized.
- •Measurable disease per RECIST v1.1 (a standard way to measure how well a cancer patient responds to treatment)
排除标准
- •Known active brain/leptomeningeal metastases (condition in which cancer cells spread from the original (primary) tumor to the meninges (thin layers of tissue that cover and protect the brain and spinal cord)
- •Female who are pregnant or breastfeeding
- •Brain disease treated with whole brain radiation
- •Known ocular melanoma (melanoma in or around the eye)
- •Known/suspected autoimmune disease (condition in which the body's immune system mistakes its own healthy tissues as foreign and attacks them) except for Type I diabetes mellitus, hypothyroidism (condition where the thyroid doesn't create and release enough thyroid hormone into the bloodstream slowing down the metabolism) only requiring hormone replacement therapy, certain skin disorders not requiring systemic treatment or condition not expected to recur without external trigger
- •History of myocarditis (inflammation of the heart muscle)
- •Condition requiring systemic treatment with corticosteroid (> 10 mg daily prednisone equivalent) or other immunosuppressive agent within 14 days of treatment, except for inhaled/topical steroid or adrenal hormone (hormone produced by gland that sits on top of kidney) replacement therapy in absence of active autoimmune disease
- •Cancer requiring treatment within 2 years prior to randomization/evidence of disease, except for basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment
- •Prior immune checkpoint inhibitor therapies, within 6 months prior to start of study treatment
- •Prior radiation therapy within 2 weeks prior to first study treatment
结局指标
主要结局
Co-Primary: The amount of study drug in your body when given SC is not worse than IV for both nivolumab and relatlimab.
Co-Primary: The amount of study drug in your body when given SC is not worse than IV for both nivolumab and relatlimab.
次要结局
- Secondary: Percentage of participants whose disease (skin cancer) decreased (Partial response – PR) and/or disappeared (Complete response – CR) after treatment when given under the skin is not worse as compared to given into the vein.
研究者
GSM-CT
Scientific
Bristol-Myers Squibb International Corporation
研究点 (76)
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