What side effects are associated with this type of intervention?

The most common treatments for melanoma include immune checkpoint inhibitors (ICIs) such as pembrolizumab and ipilimumab. Known side effects of ICIs include dermatologic reactions (e.g., rash, pruritus), gastrointestinal issues (e.g., diarrhea, colitis), hepatotoxicity, pneumonitis, and endocrinopathies (e.g., thyroid dysfunction). Fecal microbiota transplantation (FMT) is being studied for its potential to enhance the efficacy of ICIs by restoring healthy gut microbiota, but specific side effects of FMT in this context are not well-documented. Generally, FMT can cause gastrointestinal discomfort, fever, and, rarely, infections.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of melanoma. Pembrolizumab (Keytruda) and nivolumab (Opdivo) are PD-1 inhibitors approved for advanced melanoma. Ipilimumab (Yervoy), a CTLA-4 inhibitor, is also approved and often used in combination with nivolumab for enhanced efficacy. These treatments work by activating the immune system to target and destroy cancer cells, similar to the ICI therapy being studied in combination with FMT for restoring healthy gut microbiota.

What other types of research exist?

Promising novel alternatives for melanoma treatment in 2024 include: 1) Chimeric Antigen Receptor (CAR)-T cell therapies, which are being tested for their ability to target and destroy melanoma cells. 2) Modified Interleukin-2 (IL-2) agents, such as NKTR-214, designed to preferentially activate CD8+ and natural killer (NK) cells, showing potential in enhancing immune response against melanoma. 3) Gene-modified tumor-infiltrating lymphocytes (TILs) and neoantigen-targeted TILs, which have demonstrated high response rates and durable complete responses in patients with advanced melanoma. These approaches are currently under investigation and may offer new hope for melanoma patients.

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FMT + Immunotherapy for Non-Small Cell Lung Cancer or FMT + Immunotherapy for Melanoma (FMT-LUMINATE Trial)

Phase 2

Waitlist Available

Led By Arielle Elkrief, MD

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

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

Must have

Stage IV or unresectable disease

No prior anti-PD1 treatment

Must not have

Active inflammatory bowel disease

Use of antibiotics within 2 weeks of enrollment in the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This study is evaluating whether fecal microbiota transplantation (FMT) can be used to treat cancer.

Who is the study for?

Adults over 18 with certain types of advanced melanoma or non-small cell lung cancer (NSCLC) that haven't been treated with anti-PD1 drugs. They must understand the risks of fecal microbial transplantation (FMT), not have autoimmune diseases, active infections, severe heart conditions, or be pregnant. Participants should not be on high-dose steroids and must agree to effective contraception.

What is being tested?

The trial is testing the combination of FMT and immune checkpoint inhibitors (ICI) as a treatment for advanced melanoma and NSCLC. It aims to see if adding FMT can boost the anti-tumor effects of ICI therapy in patients who meet specific health criteria.

What are the potential side effects?

Potential side effects include reactions related to the immune system's activation such as inflammation in various organs, digestive issues due to FMT, increased risk of infection from both treatments, and possible infusion-related reactions from ICI therapy.

Eligibility Criteria

Inclusion Criteria

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

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My condition is at stage IV or cannot be surgically removed.

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I have never received anti-PD1 treatment.

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My cancer is melanoma or NSCLC and cannot be removed by surgery.

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I am able to get out of my bed or chair and move around.

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I am 18 years old or older.

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I am not pregnant.

Exclusion Criteria

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

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I have an active inflammatory bowel condition.

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I have not taken antibiotics in the last 2 weeks.

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I had cancer before, but I've been free of it for two years after treatment.

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I have brain metastases or leptomeningeal disease that hasn't been treated.

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I have an immune system condition or have been on strong immune system medications.

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I have an autoimmune disease that needs steroids or immunosuppressants.

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I do not have serious heart problems, infections, or inflammatory bowel disorders.

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I have a long-term serious gut condition.

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I have been diagnosed with toxic megacolon.

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I have had pneumonitis treated with steroids or have it now.

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I am currently being treated for an infection.

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I cannot receive FMT due to specific health reasons.

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I do not have HIV, AIDS, active hepatitis B, or hepatitis C.

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I have only received the flu shot, not the nasal spray vaccine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Objective response rate in the NSCLC cohort by RECIST criteria.

Secondary study objectives

Incidence of treatment-related adverse events (Safety and tolerability)

Incidence of treatment-related laboratory test abdnomarlities (Safety and tolerability)

Overall survival at 1 year in the NSCLC cohort assessed by RECIST criteria.

+1 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: Immune checkpoint inhibitor (ICI) therapy in combination with fecal microbial transplantation (FMT).Experimental Treatment1 Intervention

Metastatic or advanced NSCLC: Single-agent Pembrolizumab (2 mg/kg or 200 mg every 3 weeks) in combination with investigational FMT capsules as follows: Full FMT at least 7 days prior to first cycle of Pembrolizumab. Metastatic melanoma and uveal melanoma: Combination therapy of Ipilimumab plus Nivolumab (Ipilimumab 3 mg/kg every 3 weeks and Nivolumab 1 mg/kg every 3 weeks x 4 doses, followed by Nivolumab 3 mg/kg or 240mg every 2 weeks or 6 mg/kg or 480mg every 4 weeks) in combination with investigational FMT capsules as follows: full FMT at least 7 days prior to first treatment with Ipilimumab plus Nivolumab, followed by supportive FMT within 7 days of the second cycle with combination Ipilimumab plus Nivolumab, followed by supportive FMT within 7 days of the third cycle of Ipilimumab plus Nivolumab.

0 / 20Eligibility 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, such as immune checkpoint inhibitors (ICIs), work by blocking proteins like PD-1, PD-L1, and CTLA-4 that cancer cells use to evade the immune system. This blockade enhances the immune response against melanoma cells. Fecal microbial transplantation (FMT) is being studied in combination with ICIs to restore healthy gut microbiota, which can modulate the immune system and potentially improve the efficacy of ICIs. This combination aims to enhance anti-tumor activity, offering hope for better treatment outcomes for melanoma patients.

The Microbiome-Immune Axis Therapeutic Effects in Cancer Treatments.Integration of pharmacology, molecular pathology, and population data science to support precision gastrointestinal oncology.