2023-507688-20-00已完成3 期
A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy with Nivolumab + Relatlimab Fixed-dose Combination versus Nivolumab Monotherapy after Complete Resection of Stage III-IV Melanoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 601
- 试验地点
- 58
- 主要终点
- RFS time as assessed by the investigator. RFS is defined as the time between the date of randomization and the first date of documented recurrence (local, regional, distant, new primary melanoma), or death due to any cause, whichever occurs first. Comparison of relatlimab and nivolumab FDC vs nivolumab monotherapy.
研究概览
简要总结
To compare the efficacy, as measured by RFS, provided by nivo + rela FDC vs nivolumab monotherapy in participants with completely resected Stage III/IV NED melanoma.
入排标准
- 年龄范围
- 0 years 至 65+ years（65+ Years, 18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
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 ocular melanoma, regardless of primary site of disease, will be allowed. Note: Conjunctival melanoma is not considered to be ocular melanoma and is to be classified as mucosal melanoma.
- •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 90 days prior to randomization, with an associated pathology report, must be submitted to the central laboratory (preferably prior to randomization).
- •Participant must be ≥ 12 years of age inclusive at the time of signing the informed consent. Except: Where local regulations and/or institutional policies do not allow for participants < 18 years of age (adolescent population) to participate. For those sites, the eligible participant population is ≥ 18 years of age.
- •Participants ≥ 18 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Adolescent participants between 12 and <18 years of age must have a Lansky/Karnofsky performance score ≥ 80%.
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.
- •Participants with a history of myocarditis, regardless of etiology.
- •Prior treatment with BRAF/MEK targeted agents.
结局指标
主要结局
RFS time as assessed by the investigator. RFS is defined as the time between the date of randomization and the first date of documented recurrence (local, regional, distant, new primary melanoma), or death due to any cause, whichever occurs first. Comparison of relatlimab and nivolumab FDC vs nivolumab monotherapy.
RFS time as assessed by the investigator. RFS is defined as the time between the date of randomization and the first date of documented recurrence (local, regional, distant, new primary melanoma), or death due to any cause, whichever occurs first. Comparison of relatlimab and nivolumab FDC vs nivolumab monotherapy.
次要结局
- OS is defined as the time between the date of randomization and the date of death due to any cause. Comparison of relatlimab and nivolumab FDC vs nivolumab monotherapy.
- DMFS, by investigator, is defined as the time between the date of randomization and the date of first distant metastasis or date of death due to any cause, whichever occurs first. Comparison of relatlimab and nivolumab FDC vs nivolumab monotherapy.
- PFS2 defined as time from randomization to second recurrence/objective disease progression on next-line systemic therapy per investigator, or death from any cause, whichever occurs first. Evaluation of relatlimab and nivolumab FDC vs nivolumab monotherapy.
- Incidence and severity of AE, SAEs, AEs leading to DC, IMAEs, drugrelated AEs, deaths, laboratory abnormalities, and other select AEs, in all treated participants.
研究者
GSM-CT
Scientific
Bristol Myers Squibb International Corporation
研究点 (58)
Loading locations...
相似试验
招募中
3 期
A study of Chemo only versus Chemo plus Nivo with or without BMS986205, Followed by Post- Surgery Therapy with Nivo or Nivo and BMS986205 in Patients with MIBC2024-512158-12-00Bristol Myers Squibb International Corporation386
招募中
3 期
RegoNivo vs Standard of Care Chemotherapy in AGOC (INTEGRATEIIb)2023-505441-69-00Institut fuer Klinische Krebsforschung IKF GmbH125
招募中
3 期
Nivolumab during active surveillance after neoadjuvant chemoradiation for esophageal cancer: SANO-3 study2024-513635-24-00Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)74
招募中
2 期
Neoadjuvant Serplulimab Plus Weekly Paclitaxel and Carboplatin in TNBC (Neo-SERPENT)NCT07283692RenJi Hospital46
招募中
2 期
Immunoprevention for High-risk Lung LesionsNCT07284485Robert Samstein59