The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Checkpoint Inhibitor, Immune.
- Who it may be relevant to
- Registry conditions: Non-Small-Cell Lung Carcinoma, Malignant Melanoma, Renal Cell Carcinoma, Triple-Negative Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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
Primary outcome measures
- 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) ]]
Secondary outcome measures (3)
- Microbiome samples correlation [Time frame: Time Frame: prior to initiation of checkpoint therapy (i.e. "Baseline") and at the end of Cycle 2 (at approximately 6-8 weeks)]
- Microbiome correlation to blood biomarkers [Time frame: Time Frame: prior to initiation of checkpoint therapy (i.e. "Baseline") and at the end of Cycle 2 (at approximately 6-8 weeks)]
- Blood samples correlation [Time frame: Time Frame: prior to initiation of checkpoint therapy (i.e. "Baseline") and at the end of Cycle 2 (at approximately 6-8 weeks)]
Eligibility criteria
Inclusion criteria
- Men or women ≥18 years of age
- Screened negative for COVID-19 symptoms at time of consent, as per institutional policy and as applicable for the duration of the COVID-19 pandemic
- Diagnosed with stages I-IV primary NSCLC, MM, TNBC or RCC
- Plan to be treated at a partner cancer site with a checkpoint inhibitor (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
- Able to provide informed consent and answer study questionnaires in either English or Spanish
- Able to provide stool specimens for research purposes
Exclusion criteria
- Mental incapacity
- Incarcerated individuals
- Pregnancy (by self-report of pregnancy status)
- Experiencing active brain metastasis/metastases
- Treatment with checkpoint inhibitor in off-label capacity or through a clinical/interventional trial
- Active participation in an immuno-oncology clinical/interventional trial or pharma-sponsored observational study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Baptist Health Clinical Research — Elizabethtown
Identifiers
NCT: NCT05037825 · Pro00054854