What side effects are associated with this type of intervention?

Common treatments for melanoma, particularly immunotherapies like checkpoint inhibitors (e.g., pembrolizumab, ipilimumab), can cause a range of side effects. These include immune-related adverse events such as inflammation in various organ systems, which can manifest as colitis, hepatitis, endocrinopathies, and dermatitis. Other potential side effects include fatigue, rash, and gastrointestinal issues. Severe reactions may require discontinuation of the therapy and administration of immunosuppressive treatments.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs for the treatment of melanoma. Pembrolizumab and nivolumab, both PD-1 inhibitors, have been approved for advanced melanoma, showing improved progression-free and overall survival rates. Ipilimumab, a CTLA-4 inhibitor, has also been approved and is often used in combination with nivolumab for enhanced efficacy. Additionally, talimogene laherparepvec (T-VEC), an oncolytic virus, has been approved for local treatment of unresectable melanoma lesions. These treatments work by modulating the immune system to target and destroy melanoma cells, similar to the immunomodulatory effects being studied with beta-glucan.

What other types of research exist?

Promising novel alternatives to Beta-glucan for melanoma patients include immune checkpoint inhibitors like pembrolizumab and nivolumab, which have shown efficacy in enhancing the immune response against melanoma. Additionally, combination therapies such as pembrolizumab with bevacizumab or talimogene laherparepvec (T-VEC) are being explored for their synergistic effects. Vaccine therapies and other immune-modulating agents like thymus extracts and mushroom extracts (e.g., Reishi) are also under investigation, though their efficacy is less certain.

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Beta-Glucan for Melanoma

N/A

Recruiting

Led By Kelly M McMasters, MD

Research Sponsored by Kelly McMasters

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status of 0-3

18 years or older

Must not have

Patients receiving continuous or other ongoing immunosuppressive therapy

Patients with mucosal melanoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up blood for analysis will be drawn at baseline (day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether taking beta-glucan by mouth can help boost the immune system in patients with advanced melanoma who are already receiving Pembrolizumab. The goal is to see if this combination can make the immune system more effective at preventing cancer from coming back. Researchers will look at how well the immune system works and track patient outcomes like cancer recurrence and survival. Recent studies showed promising results about the combination of β-glucans and immune checkpoint inhibitors for patients affected by different solid tumors.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of Beta-Glucan combined with Pembrolizumab aren't detailed here, potential risks may include allergic reactions due to Beta-Glucan and typical immunotherapy-related side effects such as fatigue, skin reactions, digestive problems and changes in liver function.

Eligibility Criteria

Inclusion Criteria

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

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

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I am 18 years old or older.

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I have stage III-IV melanoma and am on Pembrolizumab with no signs of active disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on continuous immunosuppressive medication.

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I have been diagnosed with mucosal melanoma.

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

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I have another type of cancer now or had one recently.

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I have not had serious autoimmune reactions or cancer recurrence in the last 6 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ blood for analysis will be drawn at baseline (day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~blood for analysis will be drawn at baseline (day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan

This trial's timeline: 3 weeks for screening, Varies for treatment, and blood for analysis will be drawn at baseline (day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in absolute number of intracellular cytokine expression markers

Changes in absolute number of lymphocyte cell surface expression markers

Changes in fluorescent intensity of intracellular cytokine expression markers

+3 more

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: TreatmentExperimental Treatment1 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Beta-Glucan

2018

N/A

~60

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for melanoma, particularly immunotherapies, work by enhancing the body's immune response to target and destroy cancer cells. Immune checkpoint inhibitors, such as nivolumab and ipilimumab, block proteins that inhibit T-cell activation, thereby boosting the immune system's ability to attack melanoma cells. Interleukin-2 (IL-2) therapy stimulates the growth and activity of T-cells, further enhancing the immune response. T-cell transfer therapy involves extracting a patient's T-cells, modifying them to better target melanoma, and reintroducing them into the body. These treatments are crucial for melanoma patients as they offer a targeted approach to combat the cancer by leveraging the body's own immune system, potentially leading to more effective and durable responses.