An exploratory study of the biologic effects of nivolumab and nivolumab in combination with ipilimumab treatment in subjects with advanced melanoma (unresectable or metastatic). - Nivolumab and ipilimumab in advanced melanoma.

Bristol-Myers Squibb0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 10

研究概览入排标准研究者记录与标识符相似试验

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: 12 至 99（—）

入选标准

•Men and women >= 16 years of age
•Subjects must have ECOG performance status <= 1
•Subjects with advanced melanoma (unresectable or metastatic) who have received and either progressed or discontinued on no more than 3 prior treatment regimens or have refused standard therapy for treatment of metastatic melanoma.
•Subjects enrolled to Arm A, B, D and E (Part 2, 3 and 4) must never received anti-CTLA4 therapy
•Subjects must have histologic confirmation of advanced melanoma
•Subjects must have at least one measurable lesion at baseline by CT or MRI as per RECIST 1.1 criteria
•Subjects must have at least 1 tumor site that can be biopsied at acceptable clinical risk and must consent to pre- and on-treatment tumor biopsies
•Subjects enrolled to Arms D and E (Part 4)
•o Must have at least one measurable index brain metastases > 0.5 cm and not larger than 3 cm that has not been previously irradiated
•o Index brain lesions must not have sequela of prior therapy that would confound attribution of tumor response including edema or hemorrhage
•o Must not have neurologic symptoms secondary to metastatic lesions
•o Must not have received systemic corticosteroids within 14 days prior to initiation of study therapy

排除标准

•Active brain metastases within 28 days of study enrollment (Arms A and B - Part 2 & 3) within 28 days of study enrollment
•Subjects with known metastases must have a repeat imaging brain scan within 28 days of randomization/registration. If progression in prior lesion(s) or new lesion (s) is/are detected on repeat brain scan, patients are exluded from study (Arms A en B - Part 2 & 3)
•History of carcinomatous meningitis (Arms D and E - Part 4)
•Radiation within 14 days prior to initiation of study therapy, and the radiation field cannot have included the index brain lesion (Arms D and E - Part 4)
•Subjects with other concomitant malignancies, except basal cell or squamous cell skin cancers, superficial bladder cancer, or carcinoma in situ of the cervix or breast, are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period
•Subjects with active autoimmune disease, a history of known or suspected autoimmune disease or a history of a syndrome requiring systemic corticosteroids (> 10 mg daily prednisone equivalent), cytotoxic therapy or immunosuppressive medications with the exception of:
•o Isolated vitiligo
•o Resolved childhood atopy
•o The history of positive ANA titer without associated symptoms or history of symptoms of an autoimmune disorder
•o Controlled thyroid disorders
•Positive tests for HIV1/2 antibody or known acquired immunodeficiency syndrome (AIDS)
•History of any hepatitis
•Prior therapy with any antibody/drug that targets the T cell coregulatory proteins, including but not limited to, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40,and anti-CD40 antibodies

研究者

发起方

Bristol-Myers Squibb

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