EUCTR2021-001641-13-IT进行中（未招募）1 期
A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapywith Relatlimab and Nivolumab Fixed-dose Combination versus NivolumabMonotherapy after Complete Resection of Stage III-IV Melanoma - RELATIVITY 098
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,313
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- All participants must have been diagnosed with either Stage IIIA (> 1
- •mm tumor in lymph node)/B/C/D or Stage IV melanoma by AJCC v8 and
- •have histologically confirmed melanoma that is completely surgically
- •resected (free of disease) with negative margins in order to be eligible.
- •All melanomas, except uveal melanoma, regardless of primary site of
- •disease, will be allowed.
- •- All participants must have disease-free status documented by a complete physical examination within 14 days prior to randomization
- •and imaging studies within 35 days prior to randomization.
- •- Tumor tissue obtained from surgical specimen or biopsy during
- •resection collected within 3 months prior to randomization, with an
- •associated pathology report, must be submitted to the central laboratory
- •prior to randomization.
- •- Eastern Cooperative Oncology Group (ECOG) performance status = 1.
- •- Participant must be = 18 years of age inclusive at the time of signing
- •the informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 958
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 355
排除标准
- •- Prior immunotherapy treatment for any prior malignancy: No prior
- •immunotherapies are permitted (such as, but not limited to, antiprogrammed
- •death-1 (anti-PD-1), anti-programmed death ligand-1
- •(anti-PD-L1), anti-programmed death ligand-2 (PD-L2), or any other
- •antibody or drug specifically targeting T-cell costimulation or immune
- •checkpoint pathways).
- •- Prior treatment with LAG-3 targeted agents.
- •- Prior therapy for melanoma except surgery for the melanoma lesion(s)
- •and/or adjuvant radiation therapy for central nervous system lesions.
- •- Participants with an active, known, or suspected autoimmune disease.
- •Participants with type I diabetes mellitus, hypothyroidism only requiring
- •hormone replacement, skin disorders (such as vitiligo, psoriasis, or
- •alopecia) not requiring systemic treatment, or conditions not expected
- •to recur in the absence of an external trigger are permitted to enroll.
研究者
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