Tests urolithin A in cancer patients receiving immune checkpoint inhibitor therapy
Tests urolithin A against placebo for effects on immune system in adults with solid tumors.
Plain-language title generated from the registry record
Registry title: Urolithin A in Patients With Previously Untreated Solid Tumors Receiving Immune Checkpoint Inhibitors
Key facts
- Where
- Frankfurt, GermanySee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a newly diagnosed solid cancer who have not had cancer drug treatment yet and will start immune checkpoint inhibitor therapy as their first treatment.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed solid cancer (for example non-small cell lung cancer or melanoma). Life expectancy of at least 3 months and ECOG performance status 0-1.
- Earlier treatment
- No earlier systemic anticancer treatment. Planned first-line immune checkpoint inhibitor therapy, with or without chemotherapy. No chemotherapy, glucocorticoids or immune-modulating drugs in the last 3 months.
Main reasons for not taking part
- Taking or planning to take supplements such as coenzyme q10, NAD+ boosters or L-carnitine
- Earlier radiotherapy to the mediastinum or near a large blood vessel
- Known HIV infection
- Past solid organ or blood stem cell transplant
- Women who can have children and are not using highly effective contraception, are breast-feeding, or have a positive pregnancy test
Read by machine on 12 November 2026.
Where in Germany
- Universitätsklinikum Frankfurt, Medizinische Klinik II, Hämatologie/OnkologieFrankfurt, GermanyContact: Fabian Acker, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Goethe University
- Trial code
- NCT07161310
- Record updated
- 8 January 2026
- Original description
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®).Read full original descriptionShow less
A Randomized Study of Urolithin A vs. Placebo in Patients With Previously Untreated Solid Tumors Receiving Immune Checkpoint Inhibitors
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®).
Inclusion: 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; Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1; Patient is willing and able to comply with the protocol for the duration of the study, including hospital visits and scheduled follow-up visits and examinations; Female patients of childbearing potential (WOCBP) are only eligible if using highly effective contraceptive measures and must have a negative urine or serum pregnancy test within 7 days prior to start of study treatment and must not be breast-feeding prior to start of trial. Non-child-bearing potential must be evidenced by fulfilling one of the following criteria at screening:; Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments; Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution; Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
Exclusion: 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 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; Patients with a history of solid organ or hematopoietic cell transplantation6. Any medical condition that in the opinion of the investigators would compromise the study outcome or the safety of the patient; Patients who currently take or plan to take mitochondrial supplements like coenzyme q10, NAD+ boosters (e.g. nicotineamide riboside, nicotineamine mononucleotide), or L-carnitine.