Clinical trial NCT05037825: The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors
Official title: The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-Small-Cell Lung Carcinoma
Malignant Melanoma
Renal Cell Carcinoma
Triple-Negative Breast Cancer
Lead sponsor: VastBiome
Sponsor class: INDUSTRY
First posted: 2021-09-08
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Primary outcomes:
measure: 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
timeFrame: 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 outcomes:
measure: Microbiome samples correlation
timeFrame: Time Frame: prior to initiation of checkpoint therapy (i.e. "Baseline") and at the end of Cycle 2 (at approximately 6-8 weeks)
measure: Microbiome correlation to blood biomarkers
timeFrame: Time Frame: prior to initiation of checkpoint therapy (i.e. "Baseline") and at the end of Cycle 2 (at approximately 6-8 weeks)
measure: Blood samples correlation
timeFrame: Time Frame: prior to initiation of checkpoint therapy (i.e. "Baseline") and at the end of Cycle 2 (at approximately 6-8 weeks)
Other outcomes:
Locations:
city: Elizabethtown
country: United States
facility: Baptist Health Clinical Research
state: Kentucky
Study officials:
References: