Melanoma (Skin) Stage IVPhase 2FIGURE-IMNCT07686835
Dietary Fiber to Induce Gut Microbiota-mediated Response to Immunotherapy in Melanoma.
A Phase 2 study testing Dried chicory roots in people with Melanoma (Skin) Stage IV and Melanoma (Skin Cancer), run by Radboud University Medical Center at 2 sites in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin) Stage IV, Melanoma (Skin Cancer), Melanoma Metastatic
- What is being tested?
- Dried chicory roots
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesNetherlands
- Study dates
- 31 Jul 2026to 30 Apr 2029
- Phase
- Phase 2
- 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
- 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)
Who cannot join
- Symptomatic brain metastases
- 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
Show all 12Show fewer
- Use of proton pumps inhibitors (PPI's) up to 3 months prior to start of ICI
- Pregnant or lactating
- Current participation in another clinical trial requiring the use of study medication
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Isabel Ossekoppele, MS contact
Netherlands2 sites, 2 recruiting
- Not yet recruiting
Universitair Medisch Centrum Groningen
Groningen, Provincie Groningen, 9713GZ
Sjoukje Lubberts, dr., s.lubberts@umcg.nl
Kalijn Bol, dr., Kalijn.Bol@radboudumc.nl
- Recruiting
Medical Oncology
Nijmegen, Gelderland, 6525GA
Kalijn Bol, dr., Kalijn.Bol@radboudumc.nl
Isabel Ossekoppele, MS, isabel.ossekoppele@radboudumc.nl
About this study
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.
- Conditions
- Melanoma (Skin) Stage IV, Melanoma (Skin Cancer), Melanoma Metastatic, Melanoma Advanced, Melanoma
- Being tested
- Dried chicory roots, Placebo
- Keywords
- microbiota, gut microbiota, dietary fiber, life-style
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dried chicory rootsDietary supplement
Also called Dietary fibers, fiber, Vezel
The dried chicory roots are implemented using a dosage of 22.5 gram/day resulting in 18.5 gram additional fibers a day.
PlaceboDietary supplement
Also called Placebo control, Control
The control arm will receive 12.4 grams of placebo a day, isocaloric to the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Fiber intervention arm | Experimental | Dried chicory roots Receives: Dietary Supplement: Dried chicory roots |
| Placebo arm | Placebo comparator | iso-caloric placebo (rice-puffs) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
An increase in the relative abundance of Bifidobacterium in fecal samples.
The primary endpoint of this study is defined as a ≥5% (e.g. from 3% to 8%) increase in the relative abundance of Bifidobacterium in fecal samples between baseline (T0) and follow-up (T1) and significant differences between the experimental arm and the control arm.
Measured: From baseline (T0) to 3-4 weeks (T1) after start ICI
Secondary outcomes (5)
Fecal microbiota composition
Study the baseline and on-treatment gut microbiota composition of patients with melanoma treated with ICI +/- additional dietary fiber.
Measured: Measurement at baseline (T0), 3-4 weeks (T1), 3-4 months (T2), and 6-7 months (T3) after start ICI
Radiological response rate to ICI
Evaluate radiological response rates to ICI +/- additional dietary fiber, assessed by CT/PET scan per RECIST 1.1 defined as; the date of randomization to the date of disease progression or death, respectively.
Measured: From baseline (T0) to the first date of documented progression or date of death from any cause, wichever came first, assesed up to 5 year.
Progression free survival (PFS)
Evaluate progression-free survival defined as; the date of randomization to the date of disease progression or death, respectively.
Measured: From baseline (T0) to the first date of documented progression or date of death from any cause, wichever came first, assesed up to 5 year.
Overall survival (OS)
Evaluate overall survival to ICI +/- additional dietary fiber defined as; the date from randomization to date of death, respectively.
Measured: From baseline (T0) on, survival follow-up will be continued after study completion for a maximal of 5 years in accordance with standard-of-care follow-up.
Evaluate the gastro-intestinal side effects of additional dietary fiber intake
Evaluate the gastro-intestinal side effects of additional dietary fiber intake, according to CTCAE common criteria v 5.0.
Measured: From start intervention at baseline (T0) until the end of wash-out period at 6-7 months (T3) after start ICI.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start31 Jul 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin) Stage IVStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The FIGURE-IM is a randomized, double-blind, placebo-controlled, phase II clinical trial with two-arms to assess the effect of dietary fiber supplementation on the gut microbiota in patients with metastatic melanoma. Participants will be stratified based on gender and standard-of-care ICI treatment (nivolumab/pembrolizumab or nivolumab + ipilimumab). In the experimental arm the participants will receive fiber rich dried chicory roots additional to the habitual diet while receiving standard-of-care ICI treatment (nivolumab/pembrolizumab or nivolumab + ipilimumab). The participants from the placebo/control arm receive rice puffs which contain a neglectable amount of fiber while receiving standard-of-care ICI treatment (nivolumab/pembrolizumab or nivolumab + ipilimumab). Participants will be randomized 1:1.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Wageningen University and Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686835
- Sponsor's protocol ID
- R0007807A
- Acronym
- FIGURE-IM
- Status last verified
- Jul 2026
- First submitted
- 4 Jun 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Fiber to Induce Gut Microbiota-mediated Response to Immunotherapy in Melanoma.
- ClinicalTrials.gov ID
- NCT07686835
- Acronym / sponsor ID
- FIGURE-IM / R0007807A
- Conditions
- Melanoma (Skin) Stage IV, Melanoma (Skin Cancer), Melanoma Metastatic, Melanoma Advanced, Melanoma
- Keywords
- microbiota, gut microbiota, dietary fiber, life-style
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Wageningen University and Research
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 7 Jul 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The FIGURE-IM is a randomized, double-blind, placebo-controlled, phase II clinical trial with two-arms to assess the effect of dietary fiber supplementation on the gut microbiota in patients with metastatic melanoma. Participants will be stratified based on gender and standard-of-care ICI treatment (nivolumab/pembrolizumab or nivolumab + ipilimumab). In the experimental arm the participants will receive fiber rich dried chicory roots additional to the habitual diet while receiving standard-of-care ICI treatment (nivolumab/pembrolizumab or nivolumab + ipilimumab). The participants from the placebo/control arm receive rice puffs which contain a neglectable amount of fiber while receiving standard-of-care ICI treatment (nivolumab/pembrolizumab or nivolumab + ipilimumab). Participants will be randomized 1:1.
| Arm | Type | Receives |
|---|---|---|
| Fiber intervention arm | Experimental | Dietary Supplement: Dried chicory rootsDried chicory roots |
| Placebo arm | Placebo comparator | Dietary Supplement: Placeboiso-caloric placebo (rice-puffs) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- Symptomatic brain metastases
- 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
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 |
|---|---|---|
| Dried chicory rootsAlso: Dietary fibers, fiber, VezelThe dried chicory roots are implemented using a dosage of 22.5 gram/day resulting in 18.5 gram additional fibers a day. | Dietary supplement | Fiber intervention arm |
| PlaceboAlso: Placebo control, ControlThe control arm will receive 12.4 grams of placebo a day, isocaloric to the intervention. | Dietary supplement | Placebo arm |
Primary outcome
An increase in the relative abundance of Bifidobacterium in fecal samples.
Time frame: From baseline (T0) to 3-4 weeks (T1) after start ICI
The primary endpoint of this study is defined as a ≥5% (e.g. from 3% to 8%) increase in the relative abundance of Bifidobacterium in fecal samples between baseline (T0) and follow-up (T1) and significant differences between the experimental arm and the control arm.
5 secondary outcomes
Fecal microbiota composition
Time frame: Measurement at baseline (T0), 3-4 weeks (T1), 3-4 months (T2), and 6-7 months (T3) after start ICI
Radiological response rate to ICI
Time frame: From baseline (T0) to the first date of documented progression or date of death from any cause, wichever came first, assesed up to 5 year.
Progression free survival (PFS)
Time frame: From baseline (T0) to the first date of documented progression or date of death from any cause, wichever came first, assesed up to 5 year.
Overall survival (OS)
Time frame: From baseline (T0) on, survival follow-up will be continued after study completion for a maximal of 5 years in accordance with standard-of-care follow-up.
Evaluate the gastro-intestinal side effects of additional dietary fiber intake
Time frame: From start intervention at baseline (T0) until the end of wash-out period at 6-7 months (T3) after start ICI.
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 27 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Isabel Ossekoppele, MS contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dried chicory roots in people with Melanoma (Skin) Stage IV and Melanoma (Skin Cancer), run by Radboud University Medical Center at 2 sites in Netherlands.
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 7 inclusion and 12 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 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Kalijn Bol, dr. (+31 243618800, Kalijn.Bol@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
An increase in the relative abundance of Bifidobacterium in fecal samples. (time frame: From baseline (T0) to 3-4 weeks (T1) after start ICI). 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 27 Jul 2026.