Could a common supplement supercharge cancer immunotherapy?
NCT ID NCT07161310
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether urolithin A, a dietary supplement, can improve the immune system's response to standard immunotherapy drugs in people with newly diagnosed solid tumors like lung cancer or melanoma. 45 participants will be randomly assigned to receive either urolithin A or a placebo alongside their first-line immunotherapy. The main goal is to see if the supplement changes the types of immune cells in the blood.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Urolithin A (a dietary supplement)
- What this could lead to
- If it works, this could point toward a way to enhance the effectiveness of immunotherapy for solid tumors like lung cancer and melanoma.
- What could go wrong
- This is a very early, small trial (45 people) focused on immune system changes, not on curing cancer. The supplement may have no effect or could interact with treatments in unexpected ways.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Universitätsklinikum Frankfurt, Medizinische Klinik II, Hämatologie/Onkologie
RECRUITINGFrankfurt, 60590, Germany
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- Can PET scan signals predict who beats lung cancer with immunotherapy?