Urolithin A in Patients With Previously Untreated Solid Tumors Receiving Immune Checkpoint Inhibitors
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
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
Treatments tested in this trial
- Urolithin A
- Placebo
- Bio specimens
Treatment groups
45 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov