A Phase 1/2a Study of BMS-986205 Administered in Combination with Nivolumab (anti-PD-1 Monoclonal Antibody) and in Combination with Both Nivolumab and Ipilimumab (anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors

Bristol-Myers Squibb International Corporation0 个研究点目标入组 627 人开始时间: 2017年6月13日最近更新: 2024年8月26日

适应症

试验速览

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•During dose escalation, subjects with advanced solid tumors that have progressed following at least one standard regimen
•During cohort expansion, subjects with various solid tumors that either have received at least one prior therapy or are treatment naive, depending on the specified tumor type
•Subjects must have measurable disease
•Subject must consent to provide previously collected tumor tissue and must consent to a repeat tumor biopsy during screening.
•Women and men =18 years of age with performance status of 0 or 1
•At least 4 weeks since any previous treatment for cancer
•Must be able to swallow pills or capsules
•Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
•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 544
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 363

•Active or chronic autoimmune diseases
•Uncontrolled or significant cardiovascular disease
•Chronic hepatitis
•Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except for subjects with hepatocellular carcinoma)Other protocol defined inclusion/exclusion criteria could apply
•Uncontrolled or significant cardiovascular disease
•Active infection
•History of any chronic Hepatitis, active Hepatitis B or C, human immunodeficiency virus(HIV), or acquired immune deficiency syndrome(AIDS)
•Active Central nervous system (CNS) metastases and CNS metastases as the only sites of disease

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