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Urolithin A in Patients With Previously Untreated Solid Tumors Receiving Immune Checkpoint Inhibitors
Sponsor: Goethe University
Summary
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®).
Official title: A Randomized Study of Urolithin A vs. Placebo in Patients With Previously Untreated Solid Tumors Receiving Immune Checkpoint Inhibitors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2026-01-02
Completion Date
2027-03
Last Updated
2026-01-08
Healthy Volunteers
No
Interventions
Urolithin A
Patients will receive urolithin A (UA) 1,000mg QD on from day -7 until day 60 (±7) of first-line ICI-based SACT.
Placebo
Patients will receive placebo (PBO) on from day -7 until day 60 (±7) of first-line ICI-based SACT.
Bio specimens
Bio specimens (PBMC, plasma, stool) will be collected during screening and on days 1, 26 (±7) and 60 (±7) of ICI.
Locations (1)
Universitätsklinikum Frankfurt, Medizinische Klinik II, Hämatologie/Onkologie
Frankfurt, Germany