RECRUITING

The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors

Quick Facts

Study Start:2021-11-22
Study Completion:2028-09-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05037825

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Men or women ≥18 years of age
  2. 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. 3. Diagnosed with stages I-IV primary NSCLC, MM, TNBC or RCC
  4. 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. 5. Able to provide informed consent and answer study questionnaires in either English or Spanish
  6. 6. Able to provide stool specimens for research purposes
  1. 1. Mental incapacity
  2. 2. Incarcerated individuals
  3. 3. Pregnancy (by self-report of pregnancy status)
  4. 4. Experiencing active brain metastasis/metastases
  5. 5. Treatment with checkpoint inhibitor in off-label capacity or through a clinical/interventional trial
  6. 6. Active participation in an immuno-oncology clinical/interventional trial or pharma-sponsored observational study

Contacts and Locations

Study Contact

Hanane Arib, MS
CONTACT
650-479-5539
Hanane@vastbiome.com
Peter McCaffrey, MD
CONTACT
650-479-5539
Peter@vastbiome.com

Study Locations (Sites)

Baptist Health Clinical Research
Elizabethtown, Kentucky, 42701
United States

Collaborators and Investigators

Sponsor: VastBiome

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-22
Study Completion Date2028-09-14

Study Record Updates

Study Start Date2021-11-22
Study Completion Date2028-09-14

Terms related to this study

Additional Relevant MeSH Terms

  • Non-Small-Cell Lung Carcinoma
  • Malignant Melanoma
  • Renal Cell Carcinoma
  • Triple-Negative Breast Cancer