← Back to Search

Checkpoint Inhibitor

Arm 1 for Melanoma

Phase 2

Recruiting

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

ECOG performance status of 0 or 1

Age ≥ 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

Study Summary

"This trial aims to study the impact of a diet rich in prebiotic foods on the gut bacteria of melanoma patients who are not responding to standard treatment."

Who is the study for?

This trial is for adults over 18 with advanced melanoma, who can eat specific foods and are starting standard care with Ipilimumab/Nivolumab. They should be relatively healthy (ECOG 0 or 1), have measurable disease, and not be on certain medications or diets. Pregnant women, heavy drinkers/smokers, and those with some chronic diseases cannot join.Check my eligibility

What is being tested?

The study tests if a special diet rich in prebiotics can improve the gut health of patients whose melanoma didn't respond to previous immune therapies while they receive Ipilimumab/Nivolumab as their usual treatment.See study design

What are the potential side effects?

Ipilimumab and Nivolumab may cause fatigue, diarrhea, skin rash, itching, hormone gland problems like thyroid issues; less commonly lung inflammation or other organ-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fully active or can carry out light work.

Select...

I am 18 years old or older.

Select...

My cancer progressed despite or after anti-PD1/LAG3 therapy without other treatments in between.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and adverse events (AEs)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Arm 1Experimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

2014

Completed Phase 3

~2620

Nivolumab

2014

Completed Phase 3

~4750

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,336 Total Patients Enrolled

102 Trials studying Melanoma

25,254 Patients Enrolled for Melanoma

Jennifer McQuade, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the first arm of this study received approval from the Food and Drug Administration?

"Based on the information provided by our team at Power, Arm 1 has been assigned a safety rating of 2. This is because it is a Phase 2 trial where some data supports its safety but there is no evidence supporting its efficacy yet."

Answered by AI

Are there any available positions for patients to participate in this clinical trial?

"The information provided by clinicaltrials.gov states that recruitment for this particular study is currently closed. Initially shared on August 30, 2024, with the latest update on February 8, 2024. However, it's important to note that there are numerous other trials available as alternatives, with a total of 701 actively seeking participants presently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Impact of a Prebiotic Food-enriched Diet (PreFED) in Combination With Ipilimumab/Nivolumab Combination Immune Checkpoint Blockade (ICB) in ICB-refractory Melanoma Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06250335.

All > Paid Studies Houston > Paid Studies Pasadena