NCT05037825

The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: VastBiome · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The microbiome has the potential to serve as a robust biomarker of clinical response to immunotherapy. Additionally, microbial manipulation, through diet, exercise, prebiotics, probiotics, or microbially-derived metabolites, may prove to be beneficial in promoting anti-tumor immune responses. However, large prospective studies in humans with longitudinal sample collection and standardized methods are needed to understand how microbiota and their byproducts affect cancer therapies, particularly among patients undergoing identical therapy but experiencing different outcomes. The proposed observational study builds upon these hypotheses by proposing a large cohort design to further assess the associations between the gut microbiota (composition and function), host immune system, and ICI treatment efficacy across multiple cancer types.

Conditions

• Non-Small-Cell Lung Carcinoma
• Malignant Melanoma
• Renal Cell Carcinoma
• Triple-Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Checkpoint Inhibitor, Immune	anti-PD-1, anti-PD-L1, or anti-CTLA-4 as a single agent or in combination with another checkpoint inhibitor or other treatment agent or modality (e.g., targeted therapy, chemotherapy, surgery, radiation, etc.) in accordance with FDA-labeled use of the agent

Timeline

• Start date: 2021-11-22
• Primary completion: 2023-09-14
• Completion: 2028-09-14
• First posted: 2021-09-08
• Last updated: 2022-04-27

Locations

1 site across 1 country: United States