drugset / Trial / NCT05303493

Camu-Camu Prebiotic and Immune Checkpoint Inhibition in Patients With Non-small Cell Lung Cancer and Melanoma

NCT05303493

Phase 1 Completed 45 enrolled University of Montreal Hospital Centre (CHUM)
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-06-29
Primary completion
2025-07-15
Completion
2025-07-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Camu Camu Unknown 1500 mg Oral
Background Ipilimumab Monoclonal antibody
Background Nivolumab Monoclonal antibody
Background Pembrolizumab Monoclonal antibody