Multiple Phase 1/2 Cohorts of Nivolumab Monotherapy or Nivolumab Combination Regimens Across Relapsed/Refractory Hematologic Malignancies

Bristol-Myers Squibb International Corporation0 个研究点目标入组 80 人开始时间: 2019年1月18日最近更新: 2024年8月12日

适应症

试验速览

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•-Have received at least 3 prior lines of therapy, including a proteasome inhibitor [PI] and an immunomodulatory agent [IMiD] OR have disease that is double refractory to a PI and IMiD
•- More than 12 weeks post-transplant of your own blood forming stem cells (autologous transplant)
•- Have detectable disease measured by a specific protein in your blood and/or urine
•- Must consent to bone marrow aspirate or biopsy.
•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 46
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 34

•- Solitary bone or extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia, or monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis, Waldenstrom’s macroglobulinemia, POEMS syndrome or active plasma cell leukemia
•- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti CTLA 4, or anti-CD38 antibody, or allogeneic stem cell transplantation
•- Seropositive for human immunodeficiency virus (HIV), Hepatitis B surface antigen or Hepatitis C antibody positive (except if HCV-RNA negative), or history of active chronic hepatitis B or C
•- History of central nervous system involvement or symptoms suggestive of central nervous system involvement by multiple myeloma
•- Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]).
•- Seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy).

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