RecruitingNot ApplicableNCT07161310

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


Sponsor

Goethe University

Enrollment

45 participants

Start Date

Jan 2, 2026

Study Type

INTERVENTIONAL

Conditions

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®).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a natural supplement called Urolithin A — found in foods like pomegranates and berries — can help boost the effectiveness of immunotherapy (cancer treatments that use the immune system) in people newly diagnosed with solid tumors. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with a solid cancer and have not yet received any systemic treatment - Your doctor has planned immunotherapy (with or without chemotherapy) as your first treatment - You are in reasonably good physical health (able to carry out daily activities) - Your life expectancy is at least 3 months - You are willing and able to attend all study visits **You may NOT be eligible if...** - You have already received cancer treatment - You are pregnant or breastfeeding - You have serious health conditions that would prevent participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTUrolithin 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_SUPPLEMENTPlacebo

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

OTHERBio 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

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NCT07161310


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