The aim of this clinical study is to learn more about the effects of urolithin A (MitoPure®) on the immune system of cancer patients receiving immune checkpoint inhibitor-based therapies. Any effects will be compared with patients who take a placebo instead of urolithin A (MitoPure®).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
45
Patients will receive urolithin A (UA) 1,000mg QD on from day -7 until day 60 (±7) of first-line ICI-based SACT.
Patients will receive placebo (PBO) on from day -7 until day 60 (±7) of first-line ICI-based SACT.
Bio specimens (PBMC, plasma, stool) will be collected during screening and on days 1, 26 (±7) and 60 (±7) of ICI.
Universitätsklinikum Frankfurt, Medizinische Klinik II, Hämatologie/Onkologie
Frankfurt, Germany
RECRUITINGChange in the composition of circulating lymphocytes
Time frame: From enrollment to the end of urolithin A intake at 8-9 weeks
Changes in the plasma cytokine profile
Time frame: From enrollment to the end of urolithin A intake at 8-9 weeks
Transcriptional changes in immune cells
Time frame: From enrollment to the end of urolithin A intake at 8-9 weeks
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