This phase I trial studies the best dose and how well copanlisib when given together with
nivolumab works in treating patients with Richter's transformation or transformed indolent
non-Hodgkin lymphoma. Copanlisib may stop the growth of tumor cells by blocking some of the
enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab,
may help the body's immune system attack the cancer, and may interfere with the ability of
tumor cells to grow and spread. Giving copanlisib and nivolumab may work better in treating
patients with Richter's transformation or transformed non-Hodgkin lymphoma.
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
I. To evaluate the preliminary efficacy of copanlisib administered in combination with
nivolumab in patients with transformed CLL/NHL.
I. To evaluate the T-cell repertoire and activation patterns following dual targeting of PI3K
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.
Patients receive copanlisib intravenously (IV) over 60 minutes on days 1, 8, and 15 and
nivolumab IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 24
cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year.
Chronic Lymphocytic Leukemia, Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, Indolent Non-Hodgkin Lymphoma, Lymphoplasmacytic Lymphoma, Marginal Zone Lymphoma, Richter Syndrome
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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