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Metastatic CancerPhase 1/2ConsortiumIONCT04208958

Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer

A Phase 1/2 study testing VE800, Nivolumab and Vancomycin Oral Capsule in people with Metastatic Cancer and Melanoma, run by Vedanta Biosciences, Inc. at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluated the safety and efficacy of VE800 in combination with nivolumab in patients with selected types of advanced or metastatic cancer Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Cancer, Melanoma, Gastric Cancer
What is being tested?
VE800, Nivolumab and Vancomycin Oral Capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
18 sitesUnited States
Study dates
23 Jan 2020to 23 Feb 2023
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • The University of Chicago

    Chicago, Illinois, 60637

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

    Dallas, Texas, 75246

  • John Theurer Cancer Center

    Hackensack, New Jersey, 07601

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • University of California Los Angeles

    Los Angeles, California, 90095

  • New York University Medical Oncology Associates

    New York, New York, 10016

  • Weill Cornell Medicine

    New York, New York, 10065

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • Huntsman Cancer Institute and Hospital

    Salt Lake City, Utah, 84112

  • Pacific Hematology Oncology Associates

    San Francisco, California, 94115

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

    Santa Monica, California, 90404

  • University of California Los Angeles

    Santa Monica, California, 90404

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258

  • Swedish Medical Oncology - First Hill

    Seattle, Washington, 98104

  • Washington University School of Medicine Siteman Cancer Center

    St Louis, Missouri, 63110

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Phase 1 Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer

This study evaluated the safety and efficacy of VE800 in combination with nivolumab in patients with selected types of advanced or metastatic cancer

Read the detailed description

CONSORTIUM-IO was the first-in-human multicenter, open-label study; the main objectives were to evaluate:

  • Safety and tolerability of VE800 in combination with nivolumab
  • Efficacy as measured by objective response rate

The study planned to enroll approximately 111 patients with melanoma, gastric/gastroesophageal junction (GEJ) adenocarcinoma, or microsatellite-stable (MSS) colorectal cancer (CRC).

Nivolumab is already approved by the U.S. Food and Drug Administration (FDA), however, it is not approved for the study cancer indications. VE800 was the investigational product, which was designed to enhance the immune response to the tumor.

Being tested
VE800, Nivolumab, Vancomycin Oral Capsule
Keywords
Metastatic Cancer, VE800, Nivolumab, Opdivo, Melanoma, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, GEJ Adenocarcinoma, Colorectal Cancer, CRC-MSS, Vedanta, BMS
Medical subject headings
Neoplasm Metastasis, Melanoma, Stomach Neoplasms, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VE800Biological

    VE800 is an orally administered (PO) live biotherapeutic product (LBP) consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under Good Manufacturing Practice (GMP) conditions. These strains were selected for their ability to induce an immune response.

  • NivolumabDrug

    Also called Opdivo

    Nivolumab is an approved medication that blocks antibodies for certain types of cancer.

  • Vancomycin Oral CapsuleDrug

    Also called Vancocin

    Vancomycin is an antibiotic used to treat or prevent infection.

Study groups in NCT04208958
Study groupRoleWhat they receive
VE800 combination treatment with nivolumabExperimentalSubjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
Receives: Biological: VE800; Drug: Nivolumab; Drug: Vancomycin Oral Capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events

    Safety and tolerability of VE800 in combination with nivolumab: Number of Participants with Adverse Events

    Measured: From the first dose to the last dose (up to 56.7 weeks), plus 100 days of post-treatment follow-up

  2. Objective Response Rate (ORR)

    Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: 18 months (first patient enrolled to last patient visit completed)

Secondary outcomes (8)

  1. Duration of Response (DOR)

    Defined as the time from first documentation of complete response (CR) or partial response (PR) until the time of first documentation of progressive disease (PD) according to RECIST 1.1.

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: Up to two years

  2. Best Overall Response

    Best response among all overall responses from cycle 1 day 1 (C1D1) until disease progression or start of new anticancer therapy.

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: Up to 2 years

  3. Disease Control Rate (DCR)

    The percentage of patients who have achieved complete response (CR), partial response (PR), or stable disease (SD) from cycle 1 day 1 (C1D1) until disease progression (DP) or start of new anticancer therapy.

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: Up to 2 years

  4. Progression-Free Survival (PFS)

    Progression-Free Survival (PFS) is defined as the time from start of treatment to the earlier date of assessment of progression or death by any cause in the absence of progression.

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

    Measured: From the first dose to the last dose (up to 56.7 weeks), plus 100 days of post-treatment follow-up and then follow-up for survival every 90 days.

  5. Overall Survival (OS)

    Overall Survival (OS) as measured from the date of start of treatment to the date of death by any cause will also be evaluated.

    Measured: 18 months (first patient enrolled to last patient visit completed)

  6. Detection of VE800 Bacterial Strain Colonization in Stool

    Detection of VE800 bacterial strain colonization in stool was measured by pharmacokinetics (PK) of VE800

    Measured: 18 months (first patient enrolled to last patient visit completed)

  7. Degree of VE800 Bacterial Strain Colonization in Stool

    Measured by pharmacokinetics (PK) of VE800 colonization in stool

    Measured: 18 months (first patient enrolled to last patient visit completed)

  8. Duration of VE800 Bacterial Strain Colonization in Stool

    Measured by pharmacokinetics (PK) of VE800 colonization in stool

    Measured: 18 months (first patient enrolled to last patient visit completed)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2019
  2. Study start23 Jan 2020
  3. Primary completion26 Aug 2021
  4. Study completion23 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This study was designed to help determine the safety and effectiveness of the study drug, VE800, in combination with nivolumab in patients with advanced/metastatic cancer. The following cohorts of patients with advanced/metastatic cancer were enrolled: * Melanoma * Gastric/gastroesophageal junction (GEJ) adenocarcinoma * Colorectal cancer (microsatellite-stable) (CRC-MSS)
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04208958
Sponsor's protocol ID
VE800-001
Acronym
ConsortiumIO
Status last verified
Mar 2023
First submitted
16 Dec 2019
Last updated
27 Oct 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing VE800, Nivolumab and Vancomycin Oral Capsule in people with Metastatic Cancer and Melanoma, run by Vedanta Biosciences, Inc. at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events (time frame: From the first dose to the last dose (up to 56.7 weeks), plus 100 days of post-treatment follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04208958.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.

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