Impact of a Prebiotic Food-enriched Diet (PreFED) in Combination With Ipilimumab/Nivolumab Combination Immune Checkpoint Blockade (ICB) in ICB-refractory Melanoma Patients

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06250335
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • ICB-refractory Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Prebiotic Food-Enriched Diet — OTHER
    Given by PO
  • Ipilimumab — DRUG
    Given by IV
  • Nivolumab — DRUG
    Given by IV

Study Details

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.

Key Dates

Start date
Mar 1, 2024
Status verified
Jan 2026
Primary completion
Jan 23, 2027
Completion
Jan 23, 2029

Study Design

Enrollment
4 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Arm 1
    Patients receive prebiotic food-enriched snacks and supportive nutritional counseling to increase prebiotic foods in diet.

Primary Outcome Measure

Overall response rate [ Time Frame: Up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
MD Anderson Cancer Center· Houston, TX