- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06250335
Impact of a Prebiotic Food-enriched Diet (PreFED) in Combination With Ipilimumab/Nivolumab Combination Immune Checkpoint Blockade (ICB) in ICB-refractory Melanoma Patients
April 29, 2024 updated by: M.D. Anderson Cancer Center
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Primary Objectives Determining the overall response rate (ORR) to PreFED intervention + Ipi/Nivo in ICB-refractory metastatic melanoma participants.
Secondary Objectives
- Determine progression-free survival (PFS) and overall survival (OS) to PreFED + Ipi/Nivo in ICB refractory melanoma
- Adherence to interventions
- Determine the safety (AEs) and tolerability (GSRS-IBS) of the dietary intervention
- Assess the rate of immune related adverse events in participants on immunotherapy receiving dietary interventions
- Assess the effects of dietary intervention on systemic and tumor immunity
- Assess the effect of dietary intervention on gut microbiome composition and networks
- Assess the effects of dietary intervention on gut metabolic output and systemic metabolism
- Assess the effects of dietary interventions on quality of life and other participant reported outcomes (PROs)
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jennifer McQuade, MD
- Phone Number: (713) 745-9947
- Email: jmcquade@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- MD Anderson Cancer Center
-
Contact:
- Jennifer Leigh McQuade, MD
- Phone Number: 713-745-9947
- Email: jmcquade@mdanderson.org
-
Principal Investigator:
- Jennifer McQuade, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age ≥ 18 years old
- English-speaking
- Body mass index (BMI) 18.5-45 kg/m2
- ECOG performance status of 0 or 1
- Histologically confirmed stage III/IV, unresectable cutaneous melanoma. Asymptomatic brain metastases are allowed.
- 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.
- Planned initiation of standard-of-care Ipilimumab 3 mg/kg + Nivolumab 1 mg/kg
- Measurable disease per RECIST 1.1
- 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.
Exclusion Criteria:
- Prior treatment with anti-CTLA4
- Mucosal or uveal melanoma
- Concurrent malignancy requiring systemic therapy other than hormonal therapy.
- History of inflammatory bowel disease, total colectomy, or bariatric surgery
- Currently taking steroids > Prednisone 10 mg/day or equivalent
- IV antibiotic use in the past month or 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.
- 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.
- Current smoker or heavy drinker (defined as >14 drinks per week) or current illicit drug use.
- Currently pregnant, planning to become pregnant, or lactating.
- Cognitively impaired adults
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
Participants found to be eligible to take part in this study, participants will be provided with the PreFED diet during the 12-week PreFED Intervention Phase.
The PreFED diet from the MD Anderson Bionutrition Research Core's (BCR) kitchen (led by co-PI) will provide 2 fully prepared snacks for each day of the intervention phase as part of the bi-weekly food pack-out.
The snacks will be shipped to participants, or participants may pick them up in person.
|
Given by IV
Given by IV
Given by PO
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and adverse events (AEs)
Time Frame: Through study completion; an average of 1 year
|
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
|
Through study completion; an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jennifer McQuade, MD, M.D. Anderson Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2024
Primary Completion (Estimated)
January 23, 2027
Study Completion (Estimated)
January 23, 2029
Study Registration Dates
First Submitted
February 1, 2024
First Submitted That Met QC Criteria
February 8, 2024
First Posted (Actual)
February 9, 2024
Study Record Updates
Last Update Posted (Actual)
May 1, 2024
Last Update Submitted That Met QC Criteria
April 29, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Skin Neoplasms
- Melanoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Nivolumab
- Ipilimumab
Other Study ID Numbers
- 2023-1067
- NCI-2024-01235 (Other Identifier: NCI-CTRP Clinical Registry)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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