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RECRUITING
NCT07161310
NA

Urolithin A in Patients With Previously Untreated Solid Tumors Receiving Immune Checkpoint Inhibitors

Sponsor: Goethe University

View on ClinicalTrials.gov

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

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

Placebo

Patients will receive placebo (PBO) on from day -7 until day 60 (±7) of first-line ICI-based SACT.

OTHER

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