What side effects are associated with this type of intervention?

Immune checkpoint inhibitors (ICIs), commonly used in the treatment of Non-Small Cell Lung Cancer (NSCLC), can cause a range of side effects. These include fatigue, skin rash, diarrhea, and colitis. More severe immune-related adverse effects can involve inflammation of organs such as the lungs (pneumonitis), liver (hepatitis), and endocrine glands (leading to conditions like hypothyroidism or hyperthyroidism). Chemotherapy, another common treatment, often results in side effects such as nausea, vomiting, hair loss, and increased risk of infection due to lowered white blood cell counts.

What prior FDA approvals exist?

FDA-approved treatments for Non-Small Cell Lung Cancer (NSCLC) include immune checkpoint inhibitors (ICIs) such as pembrolizumab, nivolumab, and atezolizumab. These ICIs are often used in combination with chemotherapy agents like carboplatin and paclitaxel. For instance, the IMpower 150 trial demonstrated the efficacy of atezolizumab combined with bevacizumab, carboplatin, and paclitaxel (ABCP regimen), which has been FDA-approved for patients without EGFR mutations or ALK translocations. Additionally, pembrolizumab combined with chemotherapy has shown improved outcomes in the KEYNOTE-189 trial, leading to its approval for advanced nonsquamous NSCLC.

What other types of research exist?

Promising novel alternatives to Camu Camu for NSCLC patients considering treatment in 2024 include: 1) Mushroom and herb polysaccharide extracts such as Lentinus edodes extract (LenE) and Tremella fuciformis extract, which have shown prebiotic effects in modulating the gut microbiome. 2) Fruta-do-lobo (Solanum lycocarpum St. Hill) starch, which increases the growth of beneficial gut bacteria like Bifidobacterium and Lactobacillus. These alternatives could potentially enhance the efficacy of ICIs by positively influencing the gut microbiome.

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Checkpoint Inhibitor

Camu Camu + ICI for Non-Small Cell Lung Cancer

Phase 1

Recruiting

Led By Bertrand Routy, MD, PhD

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

ECOG performance status of 0-2

Ability to ingest capsules

Must not have

Has an uncontrolled autoimmune disease that requires systemic steroids or immunosuppressive agents

Has an active infection requiring systemic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 3 and 6 months, then at 12 months and up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a natural berry supplement to improve gut health in patients with advanced lung cancer and melanoma. These patients often do not respond well to current treatments. The supplement works by increasing beneficial gut bacteria, potentially making cancer treatments more effective. Berries have shown potential against several cancers, including lung cancer and melanoma, by influencing cellular processes and improving gut health.

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer (NSCLC) or melanoma, who are receiving standard immune checkpoint inhibitors (ICIs). Participants must not have had prior anti-PD1 treatments (except specific melanoma patients), be able to swallow capsules, and use effective contraception. Exclusions include recent probiotic/prebiotic use, severe immunodeficiency, active infections requiring systemic therapy, certain autoimmune diseases, and pregnancy.

What is being tested?

The study tests the safety and tolerability of Camu Camu (CC) prebiotic capsules in combination with standard ICIs in treating NSCLC and melanoma. CC may enrich beneficial gut bacteria linked to better ICI response. Patients are grouped based on their disease stage and treatment regimen.

What are the potential side effects?

Potential side effects might relate to the body's reaction to a new substance affecting the gut microbiome but specifics aren't provided. Standard ICI-related side effects can include fatigue, skin reactions, inflammation of organs like lungs or intestines, hormonal changes or flu-like symptoms.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself and perform daily activities.

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I can swallow pills.

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I am not pregnant.

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I have advanced melanoma and will be treated with anti-PD-1 therapy.

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I am 18 years old or older.

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I have stage IV or inoperable NSCLC with PD-L1 expression under 50% and will be treated with anti-PD-1 and chemotherapy.

Exclusion Criteria

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

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I am taking medication for an autoimmune disease that is not under control.

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I am currently being treated for an infection.

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

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I have been treated for cancer other than my current diagnosis in the past year.

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I don't expect to need any cancer treatment other than what's in the study.

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My cancer has spread to the lining of my brain and spinal cord.

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

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I have symptoms from cancer spread to my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 3 and 6 months, then at 12 months and up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 3 and 6 months, then at 12 months and up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 and 6 months, then at 12 months 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

Incidence of treatment-related adverse events (safety and tolerability) in patients with NSCLC and melanoma

Secondary study objectives

Objective response rate in the NSCLC and melanoma cohort by RECIST criteria.

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: Camu-camu (intervention) in addition to standard-of-care ICIExperimental Treatment1 Intervention

Camu-camu (intervention) will be added to standard-of-care ICI in: Cohort 1. For patients with advanced NSCLC, treatment will consist of single-agent pembrolizumab in combination with physician's choice platinum-doublet chemotherapy in combination with CC. Cohort 2. For patients with advanced cutaneous melanoma, treatment will consist of single-agent anti-PD-1 either nivolumab or pembrolizumab at the discretion of the treating physician. Cohort 3. For patients with advanced melanoma receiving standard-of-care ICI (either single-agent anti-PD-1 or combination anti-CTLA-4 plus anti-PD-1) who experience progressive disease (PD), their current regimen will continue unchanged and they will receive CC at 1500 mg for 3 months or until confirmed progression if progression occurs earlier.

0 / 14Eligibility 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

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include immune checkpoint inhibitors (ICIs) that target proteins like PD-1 or PD-L1, allowing the immune system to better recognize and attack cancer cells. The prebiotic Camu Camu, which enriches the gut bacterium Akkermansia muciniphila, has shown potential to improve the efficacy of ICIs. This is important for NSCLC patients as it could enhance their response to immunotherapy, potentially leading to improved treatment outcomes.