Urolithin A (MitoPure®) with immune checkpoint inhibitors for newly diagnosed solid tumors
A Randomized Study of Urolithin A vs. Placebo in Patients With Previously Untreated Solid Tumors Receiving Immune Checkpoint Inhibitors
This trial tests whether taking urolithin A (MitoPure®) alongside first-line immune checkpoint inhibitor therapy changes immune responses in adults with newly diagnosed solid tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Goethe University Academic / other |
| Drugs / interventions | chemotherapy, methotrexate |
| Locations | 1 site (Frankfurt) |
| Trial ID | NCT07161310 on ClinicalTrials.gov |
What this trial studies
Adults with newly diagnosed solid tumors who have not received prior systemic anticancer therapy and who are starting single- or double-agent immune checkpoint inhibitor therapy (with or without chemotherapy) will be enrolled. Participants will receive either urolithin A (MitoPure®) or a matching placebo while continuing standard-of-care ICI treatment, and blood and other biospecimens will be collected. The study will compare immune-system measures between the urolithin A and placebo groups to detect any differences in immune activity related to the supplement. Safety and tolerability alongside standard cancer therapy will also be monitored throughout the treatment period.
Who should consider this trial
Good fit: Adults (≥18) with newly diagnosed solid cancers who have not had prior systemic anticancer treatment, plan to start first-line single- or double-agent immune checkpoint inhibitor therapy (with or without chemotherapy), have ECOG 0–1, and a life expectancy of at least 3 months.
Not a fit: Patients who have received prior systemic anticancer therapy, have poor performance status (ECOG ≥2), or have a life expectancy under three months are unlikely to be eligible or to benefit from this intervention.
Why it matters
Potential benefit: If successful, urolithin A could boost immune responses to checkpoint inhibitors and potentially improve treatment effectiveness or tolerability for some patients.
How similar studies have performed: This approach is relatively novel: preclinical and early translational work on urolithin A and other microbiome-related metabolites suggests immune-modulating potential, but clinical evidence of benefit in combination with ICIs is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Newly diagnosed solid cancer without previous systemic anticancer treatment 2. 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 3. Age ≥ 18 years 4. Life-expectancy ≥ 3 months 5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 6. 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 7. 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 Criteria: 1. 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 2. Patients who currently take or plan to take mitochondrial supplements like coenzyme q10, NAD+ boosters (e.g. nicotineamide riboside, nicotineamine mononucleotide), or L-carnitine 3. 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 4. Patients with known HIV infection are not eligible. Testing is not mandatory 5. 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
Where this trial is running
Frankfurt
- Universitätsklinikum Frankfurt, Medizinische Klinik II, Hämatologie/Onkologie — Frankfurt, Germany (Recruiting)
Study contacts
- Study coordinator: Fabian Acker, MD
- Email: acker@med.uni-frankfurt.de
- Phone: 06963015970
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.