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Trial Title:
Impact of a Prebiotic Food-enriched Diet (PreFED) in Combination With Ipilimumab/Nivolumab Combination Immune Checkpoint Blockade (ICB) in ICB-refractory Melanoma Patients
NCT ID:
NCT06250335
Condition:
ICB-refractory Melanoma
Conditions: Official terms:
Melanoma
Nivolumab
Ipilimumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Prebiotic Food-Enriched Diet
Description:
Given by PO
Arm group label:
Arm 1
Other name:
PreFED
Intervention type:
Drug
Intervention name:
Ipilimumab
Description:
Given by IV
Arm group label:
Arm 1
Intervention type:
Drug
Intervention name:
Nivolumab
Description:
Given by IV
Arm group label:
Arm 1
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.
Detailed description:
Primary Objectives Determining the overall response rate (ORR) to PreFED intervention +
Ipi/Nivo in ICB-refractory metastatic melanoma participants.
Secondary Objectives
1. Determine progression-free survival (PFS) and overall survival (OS) to PreFED +
Ipi/Nivo in ICB refractory melanoma
2. Compliance and adherence to interventions
3. Determine the safety (AEs) and tolerability (GSRS-IBS) of the dietary intervention
4. Assess the rate of immune related adverse events in participants on immunotherapy
receiving dietary interventions
5. Assess the effects of dietary intervention on systemic and tumor immunity
6. Assess the effect of dietary intervention on gut microbiome composition and networks
7. Assess the effects of dietary intervention on gut metabolic output and systemic
metabolism
8. Assess the effects of dietary interventions on quality of life and other participant
reported outcomes (PROs)
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18 years old
2. English-speaking
3. Body mass index (BMI) 18.5-45 kg/m2
4. ECOG performance status of 0 or 1
5. Histologically confirmed stage III/IV, unresectable cutaneous melanoma. Asymptomatic
brain metastases are allowed.
6. Prior treatment with anti-PD1 or anti-PD-1 + anti-LAG3 agents and documented disease
progression either while on these agents or after stopping therapy without
intervening therapy.
7. Planned initiation of standard-of-care Ipilimumab 3 mg/kg + Nivolumab 1 mg/kg
8. Measurable disease per RECIST 1.1
9. Self-reported willingness to eat the provided foods (with some tailoring to their
food preferences)
10. Self-reported willingness to comply with scheduled visits, undergo venipuncture,
provide stool samples.
Exclusion Criteria:
1. Prior treatment with anti-CTLA4
2. Mucosal or uveal melanoma
3. Concurrent malignancy requiring systemic therapy other than hormonal therapy.
4. History of inflammatory bowel disease, total colectomy, or bariatric surgery
5. Currently taking steroids > Prednisone 10 mg/day or equivalent
6. IV antibiotic use in the past month or oral antibiotic use in past 2 weeks
7. Regularly taking supplements containing prebiotics, fiber and/or probiotics, and
unable/unwilling to discontinue for the purpose of the study.
8. Medical contraindications to the Intervention Diet as determined by the treating
physician.
9. Self-reported major dietary restrictions, including but not limited to relevant food
allergies, celiac disease, or diets such as vegan, ketogenic, extended fasting.
10. Insulin-dependent diabetes or conditions requiring bile-acid sequestrants.
11. Current smoker or heavy drinker (defined as >14 drinks per week) or current illicit
drug use.
12. Currently pregnant, planning to become pregnant, or lactating.
13. Cognitively impaired adults
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Leigh McQuade, MD
Phone:
713-745-9947
Email:
jmcquade@mdanderson.org
Investigator:
Last name:
Jennifer McQuade, MD
Email:
Principal Investigator
Start date:
March 1, 2024
Completion date:
January 23, 2029
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06250335
http://www.mdanderson.org
