Solid CancerMitoCancerNCT07161310
Urolithin A in Patients With Previously Untreated Solid Tumors Receiving Immune Checkpoint Inhibitors
A study testing Urolithin A and Bio specimens in people with Solid Cancer and Non-Small Cell Lung Cancer, run by Goethe University at 1 site in Germany.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Cancer, Non-Small Cell Lung Cancer, Melanoma
- What is being tested?
- Urolithin A and Bio specimens
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- 2 Jan 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Frankfurt, Medizinische Klinik II, Hämatologie/Onkologie
Frankfurt, 60590
Fabian Acker, MD, 06963015970, acker@med.uni-frankfurt.de
Fabian Acker, MD
About this study
Official title: 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®).
- Conditions
- Solid Cancer, Non-Small Cell Lung Cancer, Melanoma
- Being tested
- Urolithin A, Placebo, Bio specimens
- Keywords
- immune checkpoint inhibitor (ICI)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urolithin ADietary supplement
Patients will receive urolithin A (UA) 1,000mg QD on from day -7 until day 60 (±7) of first-line ICI-based SACT.
PlaceboDietary supplement
Patients will receive placebo (PBO) on from day -7 until day 60 (±7) of first-line ICI-based SACT.
Bio specimensOther
Bio specimens (PBMC, plasma, stool) will be collected during screening and on days 1, 26 (±7) and 60 (±7) of ICI.
| Study group | Role | What they receive |
|---|---|---|
| Urolithin A | Active comparator | Not described Receives: Dietary Supplement: Urolithin A; Other: Bio specimens |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo; Other: Bio specimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the composition of circulating lymphocytes
Measured: From enrollment to the end of urolithin A intake at 8-9 weeks
Secondary outcomes (2)
Changes in the plasma cytokine profile
Measured: From enrollment to the end of urolithin A intake at 8-9 weeks
Transcriptional changes in immune cells
Measured: From enrollment to the end of urolithin A intake at 8-9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start2 Jan 2026
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double-blinded, placebo-controlled, randomized (2:1), single-center study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Collaborators
- Amazentis SA, Georg-Speyer-Haus
- Responsible party
- Principal investigator, Fabian Acker, Goethe University
- Investigators
- Fabian Acker, MD, Study director, Goethe Universität
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161310
- Sponsor's protocol ID
- Mito Cancer
- Acronym
- MitoCancer
- Status last verified
- Jan 2026
- First submitted
- 22 Aug 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Urolithin A vs. Placebo in Patients With Previously Untreated Solid Tumors Receiving Immune Checkpoint Inhibitors
- ClinicalTrials.gov ID
- NCT07161310
- Acronym / sponsor ID
- MitoCancer / Mito Cancer
- Conditions
- Solid Cancer, Non-Small Cell Lung Cancer, Melanoma
- Keywords
- immune checkpoint inhibitor (ICI)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Collaborators
- Amazentis SA, Georg-Speyer-Haus
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A double-blinded, placebo-controlled, randomized (2:1), single-center study
| Arm | Type | Receives |
|---|---|---|
| Urolithin A | Active comparator | Dietary Supplement: Urolithin A, Other: Bio specimens |
| Placebo | Placebo comparator | Dietary Supplement: Placebo, Other: Bio specimens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urolithin APatients will receive urolithin A (UA) 1,000mg QD on from day -7 until day 60 (±7) of first-line ICI-based SACT. | Dietary supplement | Urolithin A |
| PlaceboPatients will receive placebo (PBO) on from day -7 until day 60 (±7) of first-line ICI-based SACT. | Dietary supplement | Placebo |
| Bio specimensBio specimens (PBMC, plasma, stool) will be collected during screening and on days 1, 26 (±7) and 60 (±7) of ICI. | Other | Placebo, Urolithin A |
Primary outcome
Change in the composition of circulating lymphocytes
Time frame: From enrollment to the end of urolithin A intake at 8-9 weeks
2 secondary outcomes
Changes in the plasma cytokine profile
Time frame: From enrollment to the end of urolithin A intake at 8-9 weeks
Transcriptional changes in immune cells
Time frame: From enrollment to the end of urolithin A intake at 8-9 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fabian Acker, MD study director
Goethe Universität
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urolithin A and Bio specimens in people with Solid Cancer and Non-Small Cell Lung Cancer, run by Goethe University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabian Acker, MD (06963015970, acker@med.uni-frankfurt.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the composition of circulating lymphocytes (time frame: From enrollment to the end of urolithin A intake at 8-9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.