Neoadjuvant Immune Checkpoint Blockade + a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma: NEO-PreFED
Recruiting
Phase 2
Interventional Study
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
- 35 (estimated)
- Sponsor
- M.D. Anderson Cancer Center · Other
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About This Trial
To Determine the feasibility, compliance and adherence to PreFED intervention in resectable melanoma patients initiating neoadjuvant Ipi/Nivo.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age ≥ 18 years old.
2. Body mass index (BMI) 18.5-45 kg/m2
3. Able to self-complete study assessments monitoring diet and gastrointestinal symptom burden
4. ECOG performance status of 0 or 1
5. Histologically confirmed resectable stage IIIB-D or oligometastatic Stage IV cutan…
Contacts