Melanoma Trial, Recruiting NCT05037825 Sponsor: VastBiome Condition: Melanoma
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Melanoma Trial, Recruiting

NCT05037825
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older
  • People who tested negative for COVID-19 symptoms at the time of joining, following the hospital's guidelines during the pandemic
  • People diagnosed with stage I–IV of one of these cancers: non-small cell lung cancer (NSCLC), melanoma (MM), triple-negative breast cancer (TNBC), or kidney cancer (RCC)
  • People whose treating doctor plans to give them a specific type of cancer immunotherapy drug (called a checkpoint inhibitor) at a participating cancer centre, used either on its own or alongside other treatments such as chemotherapy, targeted therapy, surgery, or radiation — used in the way officially approved by the FDA
  • People who are able to understand the study and complete questionnaires in English or Spanish
  • People who are able to provide stool (poo) samples for research purposes

Who may not be able to join:

  • People who are not able to give informed consent due to mental incapacity
  • People who are currently incarcerated
  • People who are pregnant (based on self-report)
  • People who currently have active cancer that has spread to the brain
  • People whose checkpoint inhibitor treatment is being used in a way that is not officially FDA-approved (called "off-label" use), or through another clinical trial
  • People who are currently taking part in another immunotherapy clinical trial or a pharmaceutical company-sponsored observational study

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 650-479-5539

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
VastBiome
Registry
ClinicalTrials.gov
Start date
22 November 2021
Est. completion
14 September 2023

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

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

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov