NL-OMON55473招募中3 期
A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy with Nivolumab versus Ipilimumab after Complete Resection of Stage IIIb/c or Stage IV Melanoma in Subjects who are at High Risk for Recurrence. - CA209-238
Bristol-Myers Squibb0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Key Inclusion Criteria:
- •At least 15 years of age
- •Except: where local regulations and/or institutional policies do not allow for
- •subjects < 18 years of age (pediatric population) to participate. For those
- •sites, the eligible subject population is >= 18 years of age.
- •All subjects must be either Stage IIIb/c or Stage IV American Joint
- •Committee on Cancer (AJCC) Melanoma Staging (7th edition) and have
- •histologically confirmed melanoma that is completely surgically resected in
- •order to be eligible. Subjects must have been surgically rendered free of
- •disease with negative margins on resected specimens. Please refer to Appendix 1
- •for description of AJCC 7th editions of TNM and staging.
- •If Stage III melanoma (whether Stage IIIb or IIIc) the subjects usually have
- •clinically detectable lymph nodes that are confirmed as malignant on the
- •pathology report and/or ulcerated primary lesions.
- •Subjects who are *N2c* classification with 2-3 metastatic nodes and in transit
- •metastases/satellites without metastatic nodes, or, *N3*classification with any
- •*T* and 4+ metastatic nodes, or matted nodes, or in transit
- •metastases/satellites with metastatic nodes are eligible. The pathology report
- •for both Stage IIIb and IIIc must be reviewed, signed and dated by the
- •investigator; this process will be confirmed during the IVRS randomization
- •call. Clinically detectable lymph nodes are defined as:
- •(1) a palpable node (confirmed as malignant by pathology)
- •(2) a non-palpable but enlarged lymph node by CT scan (at least 15 mm in short
- •axis) and confirmed as malignant by pathology., (3) a PET scan positive lymph
- •node of any size confirmed by pathology
- •(4) evidence of pathologically macrometastatic disease in one or more lymph
- •nodes defined by one or more foci of melanoma at least 1cm in diameter, If
- •Stage IV melanoma, the pathology report confirming negative margins must be
- •reviewed, dated, and signed by the investigator prior to randomization.
- •Complete resection of Stage III disease that is documented on the surgical
- •and pathology reports or complete resection of Stage IV disease with margins
- •negative for disease that is documented on the pathology report.
- •Complete resection must be performed within 12 weeks prior to randomization
- •All subjects must have disease-free status documented by a complete physical
- •examination and imaging studies
- •within 4 weeks prior to randomization. Imaging studies must include a CT scan
- •of the neck, chest, abdomen, pelvis and all known sites of resected disease in
- •the setting of Stage IIIb/c or Stage IV disease and brain magnetic resonance
- •(MRI) or CT (brain CT allowable if MRI is contraindicated or if there is no
- •known history of resected brain lesions).
- •Tumor tissue from the resected site of disease must be provided for biomarker
- •analyses. In order to be randomized, a subject must have a PD-L1 expression
- •classification (positive, negative/or indeterminate) as determined by a central
排除标准
- •Key Exclusion Criteria:
- •History of ocular/uveal melanoma
- •Subjects with active, known, or suspected autoimmune disease. Subjects with
- •type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis
- •only requiring hormone replacement, skin disorders (such as vitiligo,
- •psoriasis, or alopecia) not requiring systemic treatment are permitted to
- •Subjects with previous non-melanoma malignancies are excluded unless a
- •complete remission was achieved at least 3 years prior to study entry and no
- •additional therapy is required or anticipated to be required during the study
- •period (exceptions include but are not limited to, non-melanoma skin cancers;
- •in situ bladder cancer, in situ gastric cancer, in situ colon cancers; in situ
- •cervical cancers/dysplasia; or breast carcinoma in situ)
- •Subjects with a condition requiring systemic treatment with either
- •corticosteroids (>= 10 mg daily prednisone or equivalent) or other
- •immunosuppressive medications within 14 days of randomizationstudy drug
- •administration. Inhaled or topical steroids are permitted in the absence of
- •active autoimmune disease.
- •Prior therapy for melanoma except surgery for the melanoma lesion(s) and/or
- •except for adjuvant radiation therapy (RT) after neurosurgical resection for
- •central nervous system (CNS) lesions. and except for prior adjuvant interferon
- •(see qualifier below). Specifically subjects who received prior therapy with
- •interferon, anti- PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4
- •antibody (including ipilimumab or any other antibody or drug specifically
- •targeting T cell co-stimulation or checkpoint pathways) are not eligible.
- •i) Prior treatment with adjuvant interferon is allowed if completed >= 6 months
- •prior to randomization.
研究者
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