Immune Checkpoint Blockade + Prebiotic Diet for Melanoma

Overseen By Jennifer McQuade, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must be taking: Neoadjuvant Ipi/Nivo

Must not be taking: Steroids, Antibiotics, Supplements

Disqualifiers: Uveal melanoma, Inflammatory bowel disease, Insulin-dependent diabetes, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding a special prebiotic diet to standard cancer treatment can benefit people with certain types of melanoma, a serious skin cancer. It aims to determine if participants can adhere to this diet while receiving immune checkpoint blockade therapy, a common cancer treatment. The trial seeks individuals with a specific stage of melanoma who are ready to begin a particular cancer treatment and are willing to follow the provided diet, known as Prebiotic Xnack Packouts. This study could provide new insights into how diet might enhance cancer treatments. As a Phase 2 trial, it focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking steroids over a certain dose or regularly taking supplements with prebiotics, fiber, or probiotics unless you can stop them for the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Prebiotic Xnack Packouts diet, rich in prebiotic foods, has been studied for its effects on the gut health of melanoma patients. These studies have examined how the diet interacts with immune therapies. So far, no major safety concerns have emerged, suggesting that patients generally tolerate the diet well.

While data collection continues, the current phase of the study focuses on safety, with researchers closely monitoring for any side effects. This phase typically involves a small group of patients to identify potential risks before proceeding to larger studies. To date, these studies have reported no major negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for melanoma, which often involve surgery, chemotherapy, radiation, and immune checkpoint inhibitors, the Prebiotic Xnack Packouts take a different approach. This treatment combines immune checkpoint blockade with a prebiotic diet, aiming to enhance the body's natural immune response against melanoma. Researchers are excited because prebiotics can improve gut health, which is thought to boost immune system function. By potentially strengthening the immune system's ability to fight cancer, this novel approach could offer a complementary method to existing therapies, providing a more holistic treatment option.

What evidence suggests that this trial's treatments could be effective for melanoma?

Studies have shown that eating foods rich in prebiotics can affect the gut microbiome, influencing the body's response to immunotherapy for melanoma. In this trial, participants will follow a prebiotic food-enriched diet (PreFED) to evaluate its impact on treatment outcomes. Research suggests that combining this diet with immune checkpoint inhibitors, like Ipi/Nivo, might enhance the immune system's ability to fight melanoma. This approach aims to improve the body's cancer-fighting capability by boosting immune performance. Early findings indicate that a healthy gut microbiome might strengthen the effects of cancer treatments. While more research is needed, these initial results are promising for people with melanoma. ^{1 2 3 4 6}

Who Is on the Research Team?

Jennifer McQuade

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Body mass index (BMI) 18.5-45 kg/m2

English-speaking

Measurable disease per RECIST 1.1

Exclusion Criteria

Current smoker or heavy drinker (defined as >14 drinks per week) or current illicit drug use

I am currently taking more than 10 mg/day of Prednisone or its equivalent.

I cannot or do not want to follow the study's required procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Participants receive neoadjuvant immune checkpoint blockade therapy combined with a prebiotic food-enriched dietary intervention

2 cycles

Surgery

Participants undergo surgery to assess systemic and tumor immunity

Maintenance

Participants continue with dietary intervention and immune checkpoint blockade to assess long-term effects

Up to 2 years

Follow-up

Participants are monitored for safety, effectiveness, and survival outcomes after treatment

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Neoadjuvant Immune Checkpoint Blockade
• Prebiotic Xnack Packouts

Trial Overview 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.

How Is the Trial Designed?

Group I: Prebiotic food-enriched diet (PreFED) Experimental Treatment 1 Intervention

Participants will identified from the clinic schedules and/or referred from participant's treating oncologists.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

Prebiotics like inulin and mucin can enhance anti-tumor immune responses and inhibit melanoma growth in mice, but the presence of gut microbiota is essential for this effect, as shown by the lack of tumor inhibition in germ-free mice.

Inulin specifically not only limits tumor growth in various cancer models but also improves the effectiveness of a MEK inhibitor and helps delay drug resistance, highlighting its potential as a therapeutic strategy in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prebiotic-Induced Anti-tumor Immunity Attenuates Tumor Growth. Li, Y., Elmén, L., Segota, I., et al.[2022]

A diet high in fiber is associated with better responses to checkpoint inhibitors in cancer treatment, suggesting that nutrition may play a role in enhancing the effectiveness of immunotherapy.

The study indicates that avoiding commercial probiotics may also contribute to improved outcomes when using checkpoint inhibitors, highlighting the importance of gut health in cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low Commercial Probiotic Use and a High Fiber Diet Improves Immunotherapy Response. [2022]

In a study comparing melanoma growth in mice with different gut microbiota, the presence of Bifidobacterium was linked to improved antitumor immunity, suggesting that gut bacteria can influence immune responses to tumors.

Oral administration of Bifidobacterium alone was as effective as PD-L1-specific antibody therapy in controlling tumor growth, and when combined, they nearly eliminated tumor outgrowth, indicating that modifying the microbiota could enhance cancer immunotherapy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commensal Bifidobacterium promotes antitumor immunity and facilitates anti-PD-L1 efficacy. Sivan, A., Corrales, L., Hubert, N., et al.[2022]

The gut microbiome can predict the risk of developing immune-related adverse events (irAEs) in melanoma patients undergoing immune checkpoint blockade (ICB) therapy, with two distinct bacterial community clusters identified that show a nearly 7-fold difference in risk.

Specific bacterial strains, such as Bacteroides dorei in the high-risk group and Bacteroides vulgatus in the low-risk group, were linked to the likelihood of developing irAEs, suggesting that the gut microbiome composition may influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bacteroides vulgatus and Bacteroides dorei predict immune-related adverse events in immune checkpoint blockade treatment of metastatic melanoma. Usyk, M., Pandey, A., Hayes, RB., et al.[2022]

Metastatic melanoma patients who achieved a complete and sustained response to immunotherapy showed significant differences in their gut microbiome composition, particularly with higher diversity and specific bacterial abundances, compared to those with early responses.

These late responders also had distinct dietary habits, including lower protein and sugar intake and higher flavonoid consumption, suggesting that both microbiome and diet may play a role in enhancing the effectiveness of immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of the Gut Microbiome and Dietary Habits in Metastatic Melanoma Patients with a Complete and Sustained Response to Immunotherapy. Golčić, M., Simetić, L., Herceg, D., et al.[2023]

A study of 103 melanoma patients from Australia and the Netherlands found that gut microbiota composition significantly influences the effectiveness of immune checkpoint inhibitors (ICIs), with better responses linked to Ruminococcaceae-dominated microbiomes.

Dietary factors, such as lower fiber and omega-3 fatty acid intake, along with higher levels of systemic inflammation (C-reactive protein), were associated with poorer responses to ICIs, highlighting the importance of diet and inflammation in cancer treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet-driven microbial ecology underpins associations between cancer immunotherapy outcomes and the gut microbiome. Simpson, RC., Shanahan, ER., Batten, M., et al.[2023]

In a study of 128 melanoma patients undergoing immune checkpoint blockade (ICB) treatment, higher dietary fiber intake was linked to significantly improved progression-free survival, especially in patients not using probiotics.

Preclinical models supported these findings, showing that a low-fiber diet or probiotic use impaired the response to anti-PD-1 therapy, indicating that diet can influence the effectiveness of cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary fiber and probiotics influence the gut microbiome and melanoma immunotherapy response. Spencer, CN., McQuade, JL., Gopalakrishnan, V., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06250335

NCT06250335 | Impact of a Prebiotic Food-enriched Diet ... 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 ...

2. reporter.nih.gov reporter.nih.gov/project-details/11167700

Project Details - NIH RePORTER ... prebiotic food enriched dietary intervention influences the gut microbiomeand response to immunotherapy in melanoma. Insights gained may have far-reaching ...

3. withpower.com withpower.com/trial/phase-2-melanoma-11-2024-91117

Immune Checkpoint Blockade + Prebiotic Diet for Melanoma Prebiotic Xnack Packouts is unique because it combines immune checkpoint blockade with a prebiotic diet to enhance the body's immune response against melanoma.

4. cancer.gov cancer.gov/clinicaltrials/NCI-2024-05150

Prebiotic Food-Enriched Diet to Enhance the Microbiome ... This clinical trial studies the possible effects of a prebiotic food-enriched diet (PreFED) targeting the gut microbiome in patients with stage III-IV ...

5. trials.braintumor.org trials.braintumor.org/trials/NCT06548789

Neoadjuvant Immune Checkpoint Blockade + a Prebiotic Food ... Search Results. Neoadjuvant Immune Checkpoint Blockade + a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma: NEO-PreFED.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06466434

NCT06466434 | Prebiotic Food-enriched Diet (PreFED) to ... To learn about the possible effects of a prebiotic food-enriched diet (PreFED) targeting the gut microbiome in participants with melanoma who are starting ...