This is a multicenter, open label, pilot phase II study of the PI3K inhibitor copanlisib in
combination with a ketogenic diet in the treatment of patients with one of the following
malignancies: (a) relapsed or refractory (R/R) follicular lymphoma (FL), (b) R/R endometrial
cancer (EC) with a documented activating mutation in PIK3CA or loss of phosphatase and tensin
As the investigators recently reported ketogenic diet can suppress hyperinsulinemia
associated with PI3K inhibitors, leading to potentiation of the anti-tumor effects of PI3K
inhibitors. Copanlisib potently inhibits PI3Kα and PI3Kδ. It has been approved for the
treatment of relapsed follicular lymphoma, based on ORR of 59% (84 of 142 patients). The CR
rate in FL was 14%, and the median progression-free survival was 11.2 months. Copanlisib
demonstrated encouraging clinical activity in marginal zone lymphoma (ORR 70% including 9%
CR). While these results are clinically meaningful, FL and MZL inevitably develop resistance
to copanlisib with time, even in those patients who initially respond to the therapy. Novel
strategies to improve the efficacy of copanlisib in FL and MZL, by improving CR and PFS, may
transform how to manage these incurable malignancies.
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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