Copanlisib and Nivolumab in Treating Participants With Richter's Transformation or Transformed Indolent Non-Hodgkin's Lymphoma

Summary

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Description

PRIMARY OBJECTIVES: I. To evaluate the maximum-tolerated dose (MTD) of copanlisib administered in combination with nivolumab in patients with transformed chronic lymphocytic leukemia (CLL)/non-Hodgkin's lymphoma (NHL). SECONDARY OBJECTIVES: I. To evaluate the preliminary efficacy of copanlisib admin...

PRIMARY OBJECTIVES: I. To evaluate the maximum-tolerated dose (MTD) of copanlisib administered in combination with nivolumab in patients with transformed chronic lymphocytic leukemia (CLL)/non-Hodgkin's lymphoma (NHL). SECONDARY OBJECTIVES: I. To evaluate the preliminary efficacy of copanlisib administered in combination with nivolumab in patients with transformed CLL/NHL. EXPLORATORY OBJECTIVES: I. To evaluate the T-cell repertoire and activation patterns following dual targeting of PI3K and PD-1. II. To establish if PD-1/PD-L 1 expression correlates with response to the combination of copanlisib and nivolumab. OUTLINE: This is a dose-escalation study of copanlisib. Participants receive copanlisib intravenously (IV) over 60 minutes on days 1, 8, and 15 and nivolumab IV over 30 minutes on days 1 and 15. Courses repeat every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up every 3 months for 1 year and then every 4-6 months thereafter.

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