NCT07161310

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

A Randomized Study of Urolithin A vs. Placebo in Patients With Previously Untreated Solid Tumors Receiving Immune Checkpoint Inhibitors

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Goethe University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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®).

Conditions

• Solid Cancer
• Non-Small Cell Lung Cancer
• Melanoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-02
• Primary completion: 2027-01-01
• Completion: 2027-03-01
• First posted: 2025-09-08
• Last updated: 2026-01-08

Locations

1 site across 1 country: Germany