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The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors

NCT05037825 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2022-04-27

No results posted yet for this study

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

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

Sponsors & Collaborators

  • VastBiome

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-22
Primary Completion
2023-09-14
Completion
2028-09-14

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05037825 on ClinicalTrials.gov