The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors

Part of paid clinical trials in Elizabethtown, Kentucky.

Sponsor
VastBiome
Study ID
NCT05037825
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Checkpoint Inhibitor, Immune — DRUG
    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

Study Details

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.

Key Dates

First listed
Sep 8, 2021
Start date
Nov 22, 2021
Status verified
Apr 2022
Primary completion
Sep 14, 2023
Completion
Sep 14, 2028

Study Design

Enrollment
800 participants (estimated)

Primary Outcome Measure

Change in microbiome composition from baseline to after Cycle 2 of checkpoint therapy (6-8 weeks) by analyzing longitudinally-collected stool specimens of 800 patients with primary NSCLC, MM, RCC, and TNBC [ Time Frame: prior to initiation of checkpoint therapy (i.e. "Baseline") and at the end of Cycle 2 of checkpoint blockade immunotherapy (at approximately 6-8 weeks) ] ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baptist Health Clinical ResearchElizabethtownKentucky42701
Diane Drobny, BSN, RN, OCN, CCRP
[email protected]
(270) 706-5470

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Baptist Health Clinical Research· Elizabethtown, KY

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