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

ConditionsSolid CancerNon-Small Cell Lung CancerMelanoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGoethe University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Newly diagnosed solid cancer without previous systemic anticancer treatment

Planned single agent or double agent immune checkpoint inhibitor therapy as first-line standard-of-care treatment either with or without chemotherapy. Of note, patients receiving neoadjuvant therapy are eligible

Age ≥ 18 years

Life-expectancy ≥ 3 months

Disqualifiers

Patients who currently receive or have received cytostatic chemotherapy, glucocorticoids, or immune modulatory agents (including low-dose methotrexate, TNF alpha inhibitors, calcineurin inhibitors, interleukin inhibitors, etc.) during the last 3 months are not eligible. Of note, topical glucocorticoid treatments and hormone replacement therapy is acceptable

Patients who currently take or plan to take mitochondrial supplements like coenzyme q10, NAD+ boosters (e.g. nicotineamide riboside, nicotineamine mononucleotide), or L-carnitine

Patients who have received radiotherapy to the mediastinum or to other areas with anticipated strong irradiation of a large blood vessel by the judgement of the investigator are not eligible

Patients with known HIV infection are not eligible. Testing is not mandatory

Trial design

Design model

Parallel

Treatments tested in this trial

  • Urolithin A

    Dietary supplement

    Patients will receive urolithin A (UA) 1,000mg QD on from day -7 until day 60 (±7) of first-line ICI-based SACT.

  • Placebo

    Dietary supplement

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

  • Bio specimens

    Other intervention

    Bio specimens (PBMC, plasma, stool) will be collected during screening and on days 1, 26 (±7) and 60 (±7) of ICI.

Treatment groups

45 Participants
are divided into 2 treatment groups
Group A: Urolithin AActive comparator 2 interventions
Group B: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in the composition of circulating lymphocytes

Time frame
From enrollment to the end of urolithin A intake at 8-9 weeks

Secondary outcomes

1

Changes in the plasma cytokine profile

Time frame
From enrollment to the end of urolithin A intake at 8-9 weeks
2

Transcriptional changes in immune cells

Time frame
From enrollment to the end of urolithin A intake at 8-9 weeks

Other outcomes

Sponsors and contacts

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Goethe University

Lead sponsor

Amazentis SA

Collaborator

Georg-Speyer-Haus

Collaborator

Source ClinicalTrials.gov
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