Actively Recruiting
Urolithin A in Patients With Previously Untreated Solid Tumors Receiving Immune Checkpoint Inhibitors
Led by Goethe University · Updated on 2026-01-08
45
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
Sponsors
G
Goethe University
Lead Sponsor
A
Amazentis SA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Urolithin A in Patients With Previously Untreated Solid Tumors Receiving Immune Checkpoint Inhibitors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed solid cancer without previous systemic anticancer treatment
- Planned single or double agent immune checkpoint inhibitor therapy as first-line standard treatment, with or without chemotherapy
- Age 18 years or older
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Willing and able to follow the study protocol including hospital visits and follow-ups
- Female patients of childbearing potential must use effective contraception, have a negative pregnancy test within 7 days before starting treatment, and not be breastfeeding
- Non-childbearing potential females must meet criteria such as post-menopausal status or irreversible surgical sterilization
You will not qualify if you...
- Received cytostatic chemotherapy, glucocorticoids, or immune modulatory agents in the last 3 months (topical glucocorticoids and hormone replacement therapy allowed)
- Currently take or plan to take mitochondrial supplements like coenzyme Q10, NAD+ boosters, or L-carnitine
- Received radiotherapy to the mediastinum or areas with likely strong irradiation of large blood vessels
- Known HIV infection
- History of solid organ or hematopoietic cell transplantation
- Any medical condition that could compromise study results or patient safety according to investigators
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Trial Site Locations
Total: 1 location
1
Universitätsklinikum Frankfurt, Medizinische Klinik II, Hämatologie/Onkologie
Frankfurt, Germany, 60590
Actively Recruiting
Research Team
F
Fabian Acker, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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