Camu-Camu Prebiotic and Immune Checkpoint Inhibition in Patients With Non-small Cell Lung Cancer and Melanoma
NCT05303493 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2025-07-30
Summary
Modulating the gut microbiome to improve response to immune-checkpoint inhibitors is an active area of study. Prebiotic substances (compounds which positively shift the gut microbiome) are a reliable and safe method of gut microbiome modulation. Data suggest that the berry Camu Camu (CC), also known as Myrciaria dubia has prebiotic potential to enrich Akkermansia muciniphila, a bacterium shown to alleviate metabolic disorders and improve ICI efficacy in preclinical models. Our primary objective is to assess the safety and tolerability of CC prebiotic in patients with advanced NSCLC and melanoma in combination with standard-of-care ICI.
Conditions
- NSCLC Stage IV
- Melanoma Stage IV
- Unresectable Melanoma
- Advanced Non-Small Cell Lung Cancer
Interventions
- BIOLOGICAL
-
Camu Camu Capsules (Camu Camu powder encapsulated (500mg each) + ICI
Evaluate the safety and tolerability of CC prebiotic in addition to ICI in patients with NSCLC and melanoma
Sponsors & Collaborators
-
Centre hospitalier de l'Université de Montréal (CHUM)
lead OTHER
Principal Investigators
-
Arielle Elkrief, MD · Centre hospitalier de l'Université de Montréal (CHUM)
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-29
- Primary Completion
- 2025-07-15
- Completion
- 2025-07-15
Countries
- Canada
Study Locations
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