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NCT06250335 · ClinicalTrials.gov registry record · Phase 2
Impact of a Prebiotic Food-enriched Diet (PreFED) in Combination With Ipilimumab/Nivolumab Combination Immune Checkpoint Blockade (ICB) in ICB-refractory Melanoma Patients
A Phase 2 study of ICB-refractory Melanoma, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
- 1
- Study location
NCT06250335: Active Phase 2 study of ICB-refractory Melanoma, sponsored by M.D. Anderson Cancer Center.
NCT06250335 is a Phase 2 study of ICB-refractory Melanoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06250335, a Phase 2 study of ICB-refractory Melanoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
- 1
- Study location
Study Summary
To learn about the possible effects of a prebiotic food-enriched diet (PreFED) targeting the gut microbiome in participants with ICI-refractory melanoma who are receiving the combination of ipilimumab and nivolumab as part of their standard care.
Primary Outcome
ORR is defined as the proportion of participants whose best overall response BOR is either CR or PR. Best overall response is defined as the best response designation recorded between the date of first dose and the date of first objectively documented progression or the date of subsequent therapy, whichever occurs first per RECIST v1.1.
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- OTHER Prebiotic Food-Enriched Diet
Study Locations (1)
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2024-03-01 |
| Est. Completion | 2029-01-23 |
| Phase | Phase 2 |
What the registry record for NCT06250335 still lists
NCT06250335 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 1 condition, with ICB-refractory Melanoma appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT06250335 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06250335 about?
NCT06250335 is a clinical study titled "Impact of a Prebiotic Food-enriched Diet (PreFED) in Combination With Ipilimumab/Nivolumab Combination Immune Checkpoint Blockade (ICB) in ICB-refractory Melanoma Patients". To learn about the possible effects of a prebiotic food-enriched diet (PreFED) targeting the gut microbiome in participants with ICI-refractory melanoma who are receiving the combination of ipilimumab and nivolumab as part of their standard care.
What is the current status of trial NCT06250335?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2024-03-01. Estimated completion is 2029-01-23.
What conditions does trial NCT06250335 study?
This clinical trial studies the following conditions: ICB-refractory Melanoma.
What interventions are being tested in trial NCT06250335?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), Prebiotic Food-Enriched Diet (OTHER).
Who is sponsoring clinical trial NCT06250335?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06250335 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06250335's enrollment target sits among peer trials
4 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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