Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Bacteria cocktail aims to boost cancer immunotherapy

NCT ID NCT04208958

Disease control Sponsor: Vedanta Biosciences, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a combination of an oral bacterial product (VE800) and the immunotherapy drug nivolumab in 56 people with advanced or metastatic cancers like melanoma, stomach, and colorectal cancer. The goal was to see if the bacteria could help the immune system fight tumors better. Researchers measured safety and how many patients saw their tumors shrink.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VE800 (a mix of 11 live bacteria) plus nivolumab (Opdivo)
What this could lead to
If it works, this could point toward a new way to boost the immune system to fight advanced cancers.
What could go wrong
This is an early, small study (56 people) testing safety and response. The bacteria mix may not work for everyone, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

56 people

The number who actually took part.

Started

Jan 2020

Finished

Feb 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Partial Inclusion Criteria: * Patients with advanced or metastatic cancer who had received no more than 3 lines of prior systemic therapy for advanced/metastatic disease. * Histologically diagnosed advanced (unresectable) or metastatic cancer with at least one measurable lesion as per RECIST 1.1 * Tumor lesions amenable for biopsy, if deemed safe by the investigator * Toxicity from prior cancer therapy should have resolved to Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤ 1 (excluding alopecia and neuropathy, where up to Grade 2 residual was allowed) Partial Exclusion Criteria: * Prior treatment with immune checkpoint inhibitor (iCPI) (Note: this criterion did not apply to patients with melanoma) * Receipt of any conventional or investigational systemic anti-cancer therapy within 21 days prior to the first dose of vancomycin * Concurrent chemotherapy, immunotherapy, biologic, or hormonal anti-cancer therapy. Agents such as bisphosphonates or denosumab were acceptable as prophylaxis for bone metastasis. * Patients must not have received a transfusion (platelets or red blood cells) within 4 weeks of the first dose of study treatment * Patients with an active, known or suspected autoimmune disease. Patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment were permitted to enroll. * Patients with known active hepatitis (e.g., hepatitis B or C) NOTE: Patients with previously treated hepatitis B or C were permitted to enroll if there was evidence of documented resolution of infection. * Received a fecal transplant, spore or other preparation of fecal material, isolated bacterial products, genetically modified bacteria, or VE800

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Colorectal cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm gastric adenocarcinoma gastric cancer gastric neoplasm gastroesophageal junction adenocarcinoma melanoma metastatic malignant neoplasm Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer Gastric cancer Gastroesophageal junction adenocarcinoma Melanoma Metastatic cancer

Contacts and locations

Locations

  • Baylor Scott and White Center for Advanced Heart and Lung Disese

    Dallas, Texas, 75246, United States

  • Florida Cancer Specialists

    Sarasota, Florida, 34232, United States

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258, United States

  • Huntsman Cancer Institute and Hospital

    Salt Lake City, Utah, 84112, United States

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202, United States

  • John Theurer Cancer Center

    Hackensack, New Jersey, 07601, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • New York University Medical Oncology Associates

    New York, New York, 10016, United States

  • Pacific Hematology Oncology Associates

    San Francisco, California, 94115, United States

  • Swedish Medical Oncology - First Hill

    Seattle, Washington, 98104, United States

  • The Angeles Clinic and Research Institute - West Los Angeles Office

    Santa Monica, California, 90404, United States

  • The Miriam Hospital

    Providence, Rhode Island, 02906, United States

  • The University of Chicago

    Chicago, Illinois, 60637, United States

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University of California Los Angeles

    Los Angeles, California, 90095, United States

  • University of California Los Angeles

    Santa Monica, California, 90404, United States

  • Washington University School of Medicine Siteman Cancer Center

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medicine

    New York, New York, 10065, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.