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Recruiting NCT07161310

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

No phase Interventional Solid Cancer Non-Small Cell Lung Cancer Melanoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Urolithin A, Placebo, Bio specimens.
Who it may be relevant to
Registry conditions: Solid Cancer, Non-Small Cell Lung Cancer, Melanoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized Study of Urolithin A vs. Placebo in Patients With Previously Untreated Solid Tumors Receiving Immune Checkpoint Inhibitors

Overview

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®).

Interventions

  • Dietary supplement Urolithin A
    Patients will receive urolithin A (UA) 1,000mg QD on from day -7 until day 60 (±7) of first-line ICI-based SACT.
  • Dietary supplement Placebo
    Patients will receive placebo (PBO) on from day -7 until day 60 (±7) of first-line ICI-based SACT.
  • Other Bio specimens
    Bio specimens (PBMC, plasma, stool) will be collected during screening and on days 1, 26 (±7) and 60 (±7) of ICI.

Primary outcome measures

  • Change in the composition of circulating lymphocytes [Time frame: From enrollment to the end of urolithin A intake at 8-9 weeks]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

Germany · 1 center
  • Universitätsklinikum Frankfurt, Medizinische Klinik II, Hämatologie/Onkologie — Frankfurt

Identifiers

NCT: NCT07161310 · Mito Cancer

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗