NCT07686835RecruitingPhase 2
Dietary Fiber to Induce Gut Microbiota-mediated Response to Immunotherapy in Melanoma.
Source: ClinicalTrials.gov · Last updated 27 Jul 2026
Brief summary (registry, in English)
Previous research has shown that a higher fiber intake may have a beneficial effect on the intestinal health and improve the effectiveness of immunotherapy, but this is not certain. The objective of this double-blinded randomized clinical trial is to analyze, whether increased dietary fiber intake by patients with metastatic melanoma will increase the relative amount of Bifidobacterium, which in turn stimulates immune cell activity and improves the response to immunotherapy.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 4 Jun 2026
- Start date
- 31 Jul 2026
- Primary completion date
- 1 May 2028
- Lead sponsor
- Radboud University Medical Center
- Diseases
- Melanoma
- NCT number
- NCT07686835
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 70
- From 31 Jul 2026 to the primary completion date, 1 May 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received prior immunotherapy; previous (neo)adjuvant treatment is allowed if the last administration is at least 6 months ago
- Use of systemic immunosuppressive medications
- Use of laxatives up to 1 week prior to start of ICI
- Use of supplements that alter bowel function or gut microbiota such as fibers/prebiotics, probiotics, synbiotics, or postbiotics up to 1 month prior to start of ICI
- Use of antibiotics up to 1 months prior to start of ICI
- Use of proton pumps inhibitors (PPI's) up to 3 months prior to start of ICI
- Current participation in another clinical trial requiring the use of study medication
Other illness
- Has a known allergy to plants such as lettuce, sage, tarragon, chicory, artichoke, chamomile, daisy, or sunflower.
- Has a medical history of gastrointestinal resection (appendectomy is allowed)
- Has active inflammatory bowel disease
Other
- Symptomatic brain metastases
- Pregnant or lactating
Who the study is looking for
- Histologically confirmed cutaneous melanoma classified as irresectable stage III or stage IV disease
- Measurable disease according to RECIST 1.1 criteria
- Age ≥ 18 years
- Starting standard-of-care treatment with ICI in first line
- Written informed consent must be given
- Able to read and understand Dutch or English
- Able to comply with study procedures (e.g. willing to provide fecal samples)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Not yet recruiting |
| Medical Oncology Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.