NCT05037825 The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors
| NCT ID | NCT05037825 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VastBiome |
| Condition | Non-Small-Cell Lung Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2021-11-22 |
| Primary Completion | 2023-09-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2021-11-22 with a primary completion date of 2023-09-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05037825 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-Small-Cell Lung Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05037825 currently recruiting?
Yes, NCT05037825 is actively recruiting participants. Contact the research team at Hanane@vastbiome.com for enrollment information.
Where is the NCT05037825 trial being conducted?
This trial is being conducted at Elizabethtown, United States.
Who is sponsoring the NCT05037825 clinical trial?
NCT05037825 is sponsored by VastBiome. The trial plans to enroll 800 participants.