Urolithin A in Patients With Previously Untreated Solid Tumors Receiving Immune Checkpoint Inhibitors

NCT07161310 | Recruiting

• 1 other identifier: Mito Cancer
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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®).

Conditions

Solid Cancer; Non-Small Cell Lung Cancer; Melanoma

Keywords

immune checkpoint inhibitor (ICI)

Outcome Measures

Primary Outcomes (1)

• Change in the composition of circulating lymphocytes

  From enrollment to the end of urolithin A intake at 8-9 weeks

Secondary Outcomes (2)

• Changes in the plasma cytokine profile

  From enrollment to the end of urolithin A intake at 8-9 weeks

• Transcriptional changes in immune cells

  From enrollment to the end of urolithin A intake at 8-9 weeks

Study Arms (2)

Urolithin A

ACTIVE COMPARATOR

Dietary Supplement: Urolithin A; Other: Bio specimens

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo; Other: Bio specimens

Interventions

Urolithin A DIETARY_SUPPLEMENT

Patients will receive urolithin A (UA) 1,000mg QD on from day -7 until day 60 (±7) of first-line ICI-based SACT.

Urolithin A

Placebo DIETARY_SUPPLEMENT

Patients will receive placebo (PBO) on from day -7 until day 60 (±7) of first-line ICI-based SACT.

Placebo

Bio specimens OTHER

Bio specimens (PBMC, plasma, stool) will be collected during screening and on days 1, 26 (±7) and 60 (±7) of ICI.

Placebo; Urolithin A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Goethe University: lead
• Amazentis SA: collaborator
• Georg-Speyer-Haus: collaborator

Study Sites (1)

Universitätsklinikum Frankfurt, Medizinische Klinik II, Hämatologie/Onkologie

Frankfurt, 60590, Germany

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Melanoma

Interventions

3,8-dihydroxy-6H-dibenzo(b,d)pyran-6-one

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Fabian Acker, MD

  Goethe Universität

  STUDY DIRECTOR

Central Study Contacts

Fabian Acker, MD

CONTACT

06963015970; acker@med.uni-frankfurt.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating investigator

Model Details: A double-blinded, placebo-controlled, randomized (2:1), single-center study

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: September 8, 2025
• Study Start: January 2, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

DE (1)