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

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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

Tracking Information
First Submitted Date August 2, 2021
First Posted Date September 8, 2021
Last Update Posted Date April 27, 2022
Actual Study Start Date November 22, 2021
Estimated Primary Completion Date September 14, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 2, 2021)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 2, 2021)
  • 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).
  • 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.
  • 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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors
Official Title The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Non-Small-Cell Lung Carcinoma
  • Malignant Melanoma
  • Renal Cell Carcinoma
  • Triple-Negative Breast Cancer
Intervention 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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 2, 2021)
800
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 14, 2028
Estimated Primary Completion Date September 14, 2023   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Hanane Arib, MS 650-479-5539 Hanane@vastbiome.com
Contact: Peter McCaffrey, MD 650-479-5539 Peter@vastbiome.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05037825
Other Study ID Numbers Pro00054854
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party VastBiome
Original Responsible Party Same as current
Current Study Sponsor VastBiome
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account VastBiome
Verification Date April 2022