Beta-Glucan for Melanoma

Overseen By Matthew Woeste, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kelly McMasters

Must be taking: Pembrolizumab

Must not be taking: Immunosuppressive therapy

Disqualifiers: Autoimmune diseases, Active infection, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how beta-glucan, a natural substance in foods like oats, can aid the immune system in fighting melanoma, a serious skin cancer. Participants will receive Pembrolizumab for three weeks, followed by beta-glucan for another three weeks. The trial seeks individuals with Stage III-IV melanoma who are starting or continuing Pembrolizumab treatment and are currently cancer-free. Participants must be able to take pills and cannot have certain illnesses, such as active infections or autoimmune diseases. As an unphased trial, this study offers a unique opportunity to explore innovative treatment options for melanoma.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you cannot participate if you are on ongoing immunosuppressive therapy.

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

Research has shown that beta-glucan does not harm normal cells. Studies have found that it can slow cancer cell growth without damaging healthy cells. In fact, researchers found no negative effects on normal cells when testing beta-glucan's tumor-fighting ability. This suggests that beta-glucan is generally safe for people.

Overall, current research indicates that beta-glucan is safe to use, making it a promising option for further study in cancer treatments like melanoma. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for melanoma, which often include immune checkpoint inhibitors like pembrolizumab alone, this new approach combines pembrolizumab with beta-glucan, a natural compound derived from the cell walls of fungi, bacteria, and cereals. Beta-glucan is thought to enhance the immune response by acting as an immunomodulator, potentially boosting the effectiveness of pembrolizumab. Researchers are excited because this combination could offer a more robust immune attack against melanoma cells, possibly leading to better outcomes for patients.

What evidence suggests that beta-glucan might be an effective treatment for melanoma?

Studies have shown promising results for beta-glucan in treating melanoma. Research indicates that beta-glucan supplements significantly reduced tumor size and the number of cancer spots in the lungs in experimental models. This suggests it might help shrink tumors and prevent cancer from spreading to the lungs. In this trial, participants will receive beta-glucan following a course of Pembrolizumab, a PD-L1 antibody therapy. Previous studies indicate that when combined with PD-L1 antibody therapy, beta-glucan showed even stronger effects against tumors. This combination helps the immune system recognize and attack cancer cells. Overall, these findings suggest that beta-glucan may enhance the body's immune response against melanoma. ^{3 6 7 8 9}

Who Is on the Research Team?

Kelly M McMasters, MD

Principal Investigator

University of Louisville

Are You a Good Fit for This Trial?

This trial is for adults with Stage III-IV melanoma who are starting or have been on Pembrolizumab therapy. They should not currently have the disease, be new to treatment or haven't had it in over 6 months, and must be able to swallow pills. People with a history of beta-glucan sensitivity, other cancers, immune suppression therapy, serious illnesses like heart failure or infections, or certain mental health issues can't join.

Inclusion Criteria

I can care for myself but may not be able to do heavy physical work.

I can swallow pills.

I haven't had any treatments, or it's been over 6 months since my last treatment.

Exclusion Criteria

I am currently on continuous immunosuppressive medication.

I have been diagnosed with mucosal melanoma.

I do not have any severe illnesses that could interfere with the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Pembrolizumab for 21 days followed by beta-glucan for 21 days

6 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Beta-Glucan

Trial Overview The study is testing how Beta-Glucan affects the immune response in patients taking Pembrolizumab for advanced melanoma. It aims to see if this combination improves outcomes compared to what's expected from Pembrolizumab alone.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

All subjects will undergo 21 days of Pembrolizumab followed by 21 days of beta-glucan. Pembrolizumab: 200 mg/100mL IV in three week intervals Beta-glucan: 500mg (1 capsule) by mouth twice a day for 21 days

Who Is Running the Clinical Trial?

Kelly McMasters

Lead Sponsor

Trials

1

Recruited

30+

Published Research Related to This Trial

Certain β-glucans, specifically curdlan, yeast-b, and zymosan, can re-polarize immune-suppressive macrophages into a more active M1-like phenotype, enhancing their ability to produce immune signals and recruit other immune cells.

These β-glucans promote the secretion of chemo-attractants that help in drawing monocytes and neutrophils to the tumor site, potentially improving anti-cancer T-cell responses in the immune-suppressive tumor microenvironment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Curdlan, zymosan and a yeast-derived β-glucan reshape tumor-associated macrophages into producers of inflammatory chemo-attractants. de Graaff, P., Berrevoets, C., Rӧsch, C., et al.[2023]

Different types of beta-glucans, derived from sources like fungi, yeast, and algae, have varying effects on immune cell activation, with particulate forms showing stronger stimulation of immune responses compared to soluble forms.

The study found that certain beta-glucans, particularly Curdlan from bacteria and Zymosan from yeast, significantly enhanced lymphocyte proliferation and cytokine production, indicating their potential as immunomodulators in enhancing innate immunity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of beta-glucans on porcine leukocytes. Sonck, E., Stuyven, E., Goddeeris, B., et al.[2022]

A study on Wistar rats showed that consuming beta-glucan-enriched soluble fiber from barley at concentrations up to 7% for 28 days did not result in any adverse health effects, indicating its safety for consumption.

The only notable finding was a non-dose-dependent increase in circulating lymphocytes in male rats, which was not observed in females and did not indicate toxicity, suggesting that beta-glucan is safe even at high dietary levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the toxicity of concentrated barley beta-glucan in a 28-day feeding study in Wistar rats. Delaney, B., Carlson, T., Frazer, S., et al.[2019]

β-glucans, found in foods like mushrooms, have shown potential therapeutic effects for various conditions, including metabolic syndrome, obesity, and immune-mediated diseases, due to their ability to modulate metabolism and the gut microbiome.

Despite their promising applications, significant challenges remain in understanding the diverse mechanisms of action and the variability in effects of different β-glucan preparations, which complicates their clinical testing and therapeutic translation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

β-Glucan Metabolic and Immunomodulatory Properties and Potential for Clinical Application. Murphy, EJ., Rezoagli, E., Major, I., et al.[2020]

Oral administration of (1-->3)-beta-D-glucan significantly enhances the anti-tumor effects of monoclonal antibodies in various human tumor models, indicating its potential as a powerful adjunct therapy.

The effectiveness of beta-glucan in boosting anti-tumor responses was consistent across different tumor types and antigens, suggesting a broad applicability in cancer treatment, with a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orally administered beta-glucans enhance anti-tumor effects of monoclonal antibodies. Cheung, NK., Modak, S., Vickers, A., et al.[2020]

Insoluble yeast-derived β-glucan significantly reduced tumor weight and lung colonies in melanoma models, leading to improved overall survival rates in tested animals.

The study suggests that β-glucan enhances the effects of standard chemotherapy and protects blood cells, with some of its benefits linked to its direct action on natural killer (NK) cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glucan Supplementation Has Strong Anti-melanoma Effects: Role of NK Cells. Vetvicka, V., Vetvickova, J.[2015]

β-glucans are safe and functional polysaccharides that can enhance the immune response against tumors by activating innate immune cells, making them a promising immunostimulant in cancer treatment.

Clinical studies have shown that soluble β-glucans can effectively bind to immune cell receptors, leading to pro-inflammatory responses that bolster the body's antitumor defenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antitumor effect of soluble β-glucan as an immune stimulant. Wu, L., Zhao, J., Zhang, X., et al.[2021]

Purified β-glucan from barley was found to cause a temporary halt in the proliferation of human dermal fibroblasts, which was linked to the Retinoblastoma protein, indicating a specific mechanism of action.

In addition to affecting cell growth, barley β-glucan enhanced the migration of fibroblasts and improved wound healing in mouse skin, suggesting its potential as a therapeutic agent for promoting tissue repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barley β-glucan accelerates wound healing by favoring migration versus proliferation of human dermal fibroblasts. Fusté, NP., Guasch, M., Guillen, P., et al.[2019]

β-glucans, found in mushrooms and cereals, have shown promising anticancer properties primarily through their ability to stimulate the immune system, as evidenced by various in vitro and in vivo studies, although human studies are limited.

Clinical trials, particularly in the Far East, suggest that mushroom-derived β-glucans can improve patient survival and quality of life when used as adjuvant therapy in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

β-Glucans and their applications in cancer therapy: focus on human studies. Aleem, E.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5749667/

Systemic administration of β-glucan of 200 kDa modulates ... In this current study, we show that BG34 with a molecular weight of 200 kDa (BG34-200) does not mediate direct cytotoxicity to murine and human melanoma cells.

2. ar.iiarjournals.org ar.iiarjournals.org/content/35/10/5287

Glucan Supplementation Has Strong Anti-melanoma Effects Our data show that glucan supplementation significantly reduced the number and weight of primary tumors and the number of lung colonies. Activated macrophages ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10992518/

PD-L1 antibody enhanced β-glucan antitumor effects via ... PD-1/PD-L1 blockade therapy enhanced the β-glucan antitumor effects via the blockade of tumor-recruited CD11b + cell immune checkpoints in the melanoma model.

4. withpower.com withpower.com/trial/phase-melanoma-10-2020-cd439

Beta-Glucan for Melanoma Insoluble yeast-derived β-glucan significantly reduced tumor weight and lung colonies in melanoma models, leading to improved overall survival rates in tested ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0141813015003761

Anticancer properties of low molecular weight oat beta ... This study for the first time demonstrates that low molecular 1–3, 1–4 oat beta-glucan reveals intensive anticancer activity for human dermal cancer cells.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5069311/

Beta-glucan contamination of pharmaceutical products In other studies, the proliferation of B16-F10 melanoma cells was reduced by 51 % after 48 h exposure to 750 μg/mL of beta-glucans [52]; ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2704234/

The effects of β-glucan on human immune and cancer cells We did not find any direct cytotoxic effects of β-glucans on a panel of common cancer cell lines tested including carcinoma, sarcoma, and ...

8. portlandpress.com portlandpress.com/bioscirep/article/44/1/BSR20231686/233829/Potential-promising-anticancer-applications-of

Potential promising anticancer applications of β-glucans In cancerous cells, β-glucans can also induce apoptosis by inhibiting the telomerase activity, affecting the mitochondrial membranes, and altering the ...

9. fjps.springeropen.com fjps.springeropen.com/articles/10.1186/s43094-025-00835-1

Pharmaceutical application of beta-glucan: a comprehensive ... Additionally, BG aids in targeting tumor cells, lowering inflammation, and supporting sustained drug release, making it a useful tool in cancer ...