EUCTR2021-003208-42-PL进行中（未招募）1 期
A Phase 3, Open Label, Randomized, Non-Inferiority Pharmacokinetic Study of Nivolumab Administered Subcutaneously (Nivo SC) Versus Intravenous Administration of Nivolumab in Participants with Stage IIIA/B/C/D or Stage IV Adjuvant Melanoma Following Complete Resection - CheckMate-6GE: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 6GE
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 379
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •All participants must have been diagnosed with either Stage IIIA (> 1mm tumor in lymph node)/B/C/D or Stage IV melanoma by AJCC 8th edition and have histologically confirmed melanoma (as documented in the pathology report) that is completely surgically resected (free of disease) with negative margins in order to be eligible. All melanomas, except uveal and mucosal melanoma, regardless of primary site of disease, will be allowed.
- •Complete resection must be performed within 12 weeks prior to
- •randomization (Part 1) or treatment assignment (Part 2). Management of residual lymph nodes after positive sentinel lymph node biopsy (ie, completion lymph node dissection) will be as per local standards and recommendations for the individual participant.
- •Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of = 1.
- •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 276
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 103
排除标准
- •History of uveal or mucosal melanoma.
- •Untreated/unresected CNS metastases or leptomeningeal metastases.
- •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 serious or uncontrolled medical disorders within 4 weeks prior to screening.
- •- Additionally, in the case of prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, acute symptoms must have resolved and based on investigator assessment in consultation with the Medical Monitor, there are no sequelae that would place the participant at a higher risk of receiving investigational treatment.
- •Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization (Part 1) or treatment assignment (Part 2) (ie, participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization/treatment assignment and the patient has no evidence of disease). Participants with history of prior early stage basal/squamous cell skin cancer or noninvasive or in situ cancers that have undergone definitive treatment at any time are also eligible.
- •Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- •Any condition that according to investigator criteria makes a participant ineligible from participation in the study, including but not limited to medical conditions (including psychological, psychiatric), or social conditions; or conditions that can impact ability to comply with protocol requirements (eg, conditions that preclude the use of IV or subcutaneous [SC] route of study drug administration) or that can put the participant at risk. Participants with history of self-harm including suicidal attempts will be excluded from the study.
- •Prior immunotherapy treatments for any prior malignancies are not permitted (such as, but not limited to anti-programmed death-1, anti-programmed death-ligand 1, anti-programmed death-ligand 2, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways).
- •Participants treated with anti-cancer therapy directed against the resected melanoma (for example, but not limited to, systemic, local, radiation, and radiopharmaceuticals) except:
- •- Surgery for the melanoma lesion(s)
- •- Adjuvant radiation therapy after neurosurgical resection for CNS lesions
- •- Prior adjuvant interferon completed = 6 months prior to randomization (Part 1) or treatment assignment (Part 2).
- •Treatment with any live attenuated vaccine within 30 days of first study treatment (Vaccines that are not live attenuated are allowed, including COVID-19 vaccines).
- •History of allergy or hypersensitivity to study drug components or device components.
- •Known human immunodeficiency virus (HIV) positive with an AIDS defining opportunistic infection within the last year, or a curre
研究者
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