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The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors (PARADIGM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05037825
Recruitment Status : Recruiting
First Posted : September 8, 2021
Last Update Posted : April 27, 2022
Sponsor:
Information provided by (Responsible Party):
VastBiome

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Non-Small-Cell Lung Carcinoma Malignant Melanoma Renal Cell Carcinoma Triple-Negative Breast Cancer Drug: Checkpoint Inhibitor, Immune

Study Design
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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors
Actual Study Start Date : November 22, 2021
Estimated Primary Completion Date : September 14, 2023
Estimated Study Completion Date : September 14, 2028

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • 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

Outcome Measures
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Primary Outcome Measures :
  1. 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) ] ]
    Microbiome evaluation with whole metagenome shotgun sequencing to assess changes in the relative abundance of microbial taxa (measured as percentage abundance per microbial species and changes in percentage abundance between baseline and cycle 2 timepoints) in patients who are receiving checkpoint blockade immunotherapy as the standard of care


Secondary Outcome Measures :
  1. 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) ]
    Definition of a correlation between the gut microbiome and circulating cytokines (specifically IL-2, IL-10, TNF-alpha, IFN-gamma, and G-CSF) and therapeutic response (defined using RECIST criteria).

  2. 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) ]
    Definition of a correlation between the gut microbiome (measured as percent abundance of microbial taxa derived from whole-metagenome shotgun sequencing) and plasma metabolites (measured in m/z and peak intensities and--where possible--compound abundances in ng/mL) and circulating cytokines (measured in pg/mL per cytokine) in patients receiving checkpoint blockade immunotherapy.

  3. 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) ]
    Definition of a correlation between plasma metabolites (measured in m/z and peak intensities and--where possible--compound abundances in ng/mL) and circulating cytokines (measured in pg/mL per cytokine) and therapeutic response (defined using RECIST criteria).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The investigator propose to enroll 800 cancer patients (NSCLC, MM, RCC, and TNBC; any stage) who are about to begin standard of care ICI therapy into a multi-site prospective observational study of the gut microbiome.
Criteria

Inclusion Criteria:

  1. Men or women ≥18 years of age
  2. 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
  3. Diagnosed with stages I-IV primary NSCLC, MM, TNBC or RCC
  4. 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
  5. Able to provide informed consent and answer study questionnaires in either English or Spanish
  6. Able to provide stool specimens for research purposes

Exclusion Criteria:

  1. Mental incapacity
  2. Incarcerated individuals
  3. Pregnancy (by self-report of pregnancy status)
  4. Experiencing active brain metastasis/metastases
  5. Treatment with checkpoint inhibitor in off-label capacity or through a clinical/interventional trial
  6. Active participation in an immuno-oncology clinical/interventional trial or pharma-sponsored observational study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05037825


Contacts
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Contact: Hanane Arib, MS 650-479-5539 Hanane@vastbiome.com
Contact: Peter McCaffrey, MD 650-479-5539 Peter@vastbiome.com

Locations
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United States, Kentucky
Baptist Health Clinical Research Recruiting
Elizabethtown, Kentucky, United States, 42701
Contact: Diane Drobny, BSN, RN, OCN, CCRP    (270) 706-5470    Delores.Drobny@bhsi.com   
Sponsors and Collaborators
VastBiome
More Information
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Responsible Party: VastBiome
ClinicalTrials.gov Identifier: NCT05037825    
Other Study ID Numbers: Pro00054854
First Posted: September 8, 2021    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Melanoma
Carcinoma, Renal Cell
Triple Negative Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Adenocarcinoma
Kidney Neoplasms
 Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Breast Neoplasms
Breast Diseases
Skin Diseases
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms