Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma
Recruiting
Phase 2
Interventional Study
Unresectable Melanoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 75 (estimated)
- Sponsor
- M.D. Anderson Cancer Center · Other
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About This Trial
To learn about the possible effects of a prebiotic food-enriched diet (PreFED) targeting the gut microbiome in participants with melanoma who are starting immune checkpoint blockade (ICB) therapy.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age ≥18 years old
* English-speaking
* Body mass index (BMI) 18.5-45 kg/m2
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Histologically confirmed stage III/IV, unresectable cutaneous, uveal, acral or mucosal melanoma. Asymptomatic brain metastases …
Contacts