EUCTR2019-001230-34-IT进行中（未招募）1 期
A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapywith Nivolumab versus Placebo after Complete Resection of Stage IIB/CMelanoma(CheckMate 76K: CHECKpoint pathway and nivoluMAb clinical TrialEvaluation 76K) - CheckMate 76K
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 780
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
- •a) Participants must have been diagnosed with stage IIB/C cutaneous
- •melanoma (AJCC Cancer Staging, 8th edition) and have histologically
- •confirmed melanoma that is completely surgically resected with
- •documented negative margins (per local standard) for disease on
- •resected specimens. All melanomas, except ocular and mucosal
- •regardless of primary site of disease will be allowed.
- •b) Complete resection must be performed within 12 weeks prior to
- •randomization.
- •Participants must have had a negative sentinel lymph node biopsy.
- •Patients in whom a sentinel lymph node biopsy procedure could not be
- •done or a sentinel lymph node was not detected are not eligible.
- •c) Participants must have disease-free status documented by a complete
- •physical examination (within 14 days) and imaging studies within 4
- •weeks (28 days) prior to randomization.
- •Imaging studies must include CT scans of the chest/abdomen/pelvis or CT scan of the chest and MRI scans of the abdomen and pelvis, and all
- •known sites of resected disease (lymph nodes = 15 mm in short axis).
- •Participants with signs and symptoms consistent with brain metastases
- •should have imaging studies done to rule out the presence of brain
- •metastases.
- •d) Has not been previously treated for melanoma beyond complete
- •surgical resection of the
- •melanoma lesion.
- •e) Has recovered adequately from toxicity and/or complications from
- •surgery prior to study
- •f) ECOG performance status of 0 or 1 at the time of enrollment
- •g) Tumor tissue (minimum of 15 unstained slides or 1 FFPE block) from
- •the resected site of disease must be provided to the central lab prior to
- •randomization.
- •Are the trial subjects under 18? yes
- •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 444
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 553
排除标准
- •a) History of ocular and mucosal melanoma.
- •b) Participants with 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.
- •c) Prior malignancy active within the previous 3 years except for locally
- •curable cancers that have been apparently cured, such as basal or
- •squamous cell skin cancer, superficial bladder cancer, or carcinoma in
- •situ of the prostate, cervix, or breast.
- •d) Participants with a condition requiring systemic treatment with either
- •corticosteroids (> 10 mg daily prednisone equivalent) or other
- •immunosuppressive medications within 14 days of randomization.
- •Inhaled or topical steroids, and adrenal replacement steroid doses > 10
- •mg daily prednisone equivalent, are permitted in the absence of active
- •autoimmune disease.
- •e) Women who are pregnant or breastfeeding
- •f) Participants with serious or uncontrolled medical disorders.
研究者
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