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Behavioural Intervention
Immune Checkpoint Blockade + Prebiotic Diet for Melanoma
Phase 2
Waitlist Available
Led By Jennifer McQuade, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years old
Histologically confirmed resectable stage IIIB-D or oligometastatic Stage IV cutaneous melanoma or locally invasive/advanced mucosal melanoma as determined by multidisciplinary review
Must not have
Currently taking steroids > Prednisone 10 mg/day or equivalent
Unable or unwilling to undergo study procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to see if resectable melanoma patients starting a combination treatment before surgery can easily follow the treatment plan and stick to it."
Who is the study for?
This trial is for individuals with melanoma that can be surgically removed. They are looking to see if people will follow a special diet containing Prebiotic Xnack Packouts while also receiving immune checkpoint blockade therapy.
What is being tested?
The study tests whether adding a prebiotic-enriched diet (PreFED) improves the effectiveness of neoadjuvant Ipi/Nivo, an immunotherapy treatment, in patients with resectable melanoma.
What are the potential side effects?
While specific side effects aren't listed here, typical ones from immune therapies like Ipi/Nivo include fatigue, skin reactions, digestive issues, and potential autoimmune responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My melanoma is at a stage where surgery is possible.
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I am fully active or can carry out light work.
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I am starting treatment with Ipilimumab + Nivolumab or Nivolumab + Relatlimab.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking more than 10 mg/day of Prednisone or its equivalent.
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I cannot or do not want to follow the study's required procedures.
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I have had inflammatory bowel disease, total colectomy, or bariatric surgery.
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I have not taken IV antibiotics in the last month or oral antibiotics in the last 2 weeks.
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I have cognitive impairment.
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I have diabetes that requires insulin or I need medication to manage my cholesterol.
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I am receiving treatment for another cancer that is not just hormone therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The completion rate, compliance and adherence.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Prebiotic food-enriched diet (PreFED)Experimental Treatment1 Intervention
Participants will identified from the clinic schedules and/or referred from participant's treating oncologists.
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,071 Previous Clinical Trials
1,803,195 Total Patients Enrolled
108 Trials studying Melanoma
25,947 Patients Enrolled for Melanoma
Jennifer McQuade, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
135 Total Patients Enrolled
2 Trials studying Melanoma
135 Patients Enrolled for Melanoma