NCT06548789RecruitingPhase 2
Neoadjuvant Immune Checkpoint Blockade + a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma: NEO-PreFED
M.D. Anderson Cancer Center1 site in 1 country35 target enrollmentStarted: September 16, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- The completion rate, compliance and adherence.
Study Overview
Brief Summary
To Determine the feasibility, compliance and adherence to PreFED intervention in resectable melanoma patients initiating neoadjuvant Ipi/Nivo.
Detailed Description
Primary Objectives:
Determine the feasibility, compliance and adherence to PreFED intervention in patients with resectable melanoma initiating neoadjuvant combination ICB therapy.
Secondary Objectives:
- Determine the safety (AEs) and tolerability (GSRS-IBS) of the dietary intervention during the neoadjuvant phase and maintenance phases
- Assess the rate of immune related adverse events in patients of dietary intervention + ICB during neoadjuvant and maintenance phases.
- Determine the objective response rate (ORR) to dietary intervention + ICB as determined by RECIST1.1 after 2 cycles of neoadjuvant ICB + diet
- Determine the pathological response rate (pRR) to neoadjuvant ICB + dietary intervention
- Determine the Event-free Survival (EFS), Relapse-free Survival (RFS), and Overall Survival (OS) to neoadjuvant ICB + dietary intervention
Exploratory Objectives:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years old.
- •Body mass index (BMI) 18.5-45 kg/m2
- •Able to self-complete study assessments monitoring diet and gastrointestinal symptom burden
- •ECOG performance status of 0 or 1
- •Histologically confirmed resectable stage IIIB-D or oligometastatic Stage IV cutaneous melanoma or locally invasive/advanced mucosal melanoma as determined by multidisciplinary review
- •Planned initiation of standard-of-care neoadjuvant anti-PD1 +/- anti-CTLA4 or anti-LAG3 inhibitors or talimogene laherparepvec (T-VEC)
- •Measurable disease per RECIST 1.1
- •WOCP must have negative UPT within 1 week of beginning dietary intervention.
- •Self-reported willingness to eat the provided foods (with some tailoring to their food preferences)
- •Self-reported willingness to comply with scheduled visits, undergo venipuncture, provide stool samples.
- •Archival tissue specimen or planned to undergo tumor biopsy as part of standard of care treatment.
Exclusion Criteria
- •Uveal melanoma
- •History of inflammatory bowel disease, total colectomy, or bariatric surgery
- •Currently taking steroids > prednisone 10 mg/day or equivalent
- •Medical contraindications to the intervention diet as determined by the treating physician
- •Self-reported major dietary restrictions, including but not limited to relevant food allergies, celiac disease, or diets such as vegan, ketogenic, extended fasting
- •Insulin-dependent diabetes or conditions requiring bile-acid sequestrants
- •Unable or unwilling to undergo study procedures
- •Intravenous (IV) antibiotic >1 dose in the past month or 1 dose IV/oral antibiotic use in past 2 weeks
- •Regularly taking supplements containing prebiotics, fiber and/or probiotics, and unable/unwilling to discontinue for the purpose of the study
- •Current smoker or heavy drinker (defined as >14 drinks per week) or current illicit drug use
- •Currently pregnant, planning to become pregnant, or lactating
- •Concurrent malignancy requiring systemic therapy other than hormonal therapy
- •Cognitively impaired adults
Arms & Interventions
Prebiotic food-enriched diet (PreFED)
Experimental
Participants will identified from the clinic schedules and/or referred from participant's treating oncologists.
Intervention: Prebiotic Xnack Packouts (Dietary Supplement)
Outcomes
Primary Outcomes
The completion rate, compliance and adherence.
Time Frame: Up to 2 years
The completion rate is defined as proportion of participants completed the intervention. Among subjects that complete the PreFED intervention, compliance is defined as the proportion (%) of prebiotic snacks consumed versus provided and proportion (%) of counselling sessions attended, while adherence is defined as the number of servings of prebiotic foods the participant consumed.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Unknown
Phase 1
A Study of HX008 Plus LP002 for the Treatment of Patients With Advanced MelanomaMelanomaNCT04756934Taizhou HoudeAoke Biomedical Co., Ltd.63
Active, not recruiting
Phase 2
Neoadjuvant Immune Checkpoint Blockade in Resectable Malignant Pleural MesotheliomaMesotheliomaNCT03918252Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins30
Suspended
Phase 2
Neoadjuvant T-VEC in High Risk Early MelanomaMelanomaNCT04427306University of California, Davis6
Unknown
Phase 2
Pembrolizumab as Neoadjuvant Treatment in HCCHepatocellular CarcinomaNCT03337841Kindai University50
Recruiting
Phase 2
Melanoma Metastasized to the Brain and SteroidsMalignant MelanomaNCT03563729Inge Marie Svane80