CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 56 enrolled
Drug / intervention
VE800 +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04208958
NCT04208958Phase 2Completed
CompareCT.gov

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

Vedanta Biosciences, Inc.·interventional·Posted Dec 23, 2019·Updated Oct 27, 2025

In Brief

A Phase 2 clinical trial evaluating VE800, Nivolumab, and 1 other intervention for Metastatic Cancer and 4 related conditions. Completed, enrolled 56 participants across 18 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Cancer, Melanoma, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Colorectal Cancer
CountriesUnited States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedDec 23, 2019
Enrollment StartJan 23, 2020
Primary CompletionAug 26, 2021
Study CompletionFeb 23, 2023
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 6.5 years ago

Interventions

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

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

Vancomycin Oral Capsuledrug

Vancomycin is an antibiotic used to treat or prevent infection.