Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer
NCT04208958 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2025-10-27
Summary
This study evaluated the safety and efficacy of VE800 in combination with nivolumab in patients with selected types of advanced or metastatic cancer
Conditions
- Metastatic Cancer
- Melanoma
- Gastric Cancer
- Gastroesophageal Junction Adenocarcinoma
- Colorectal Cancer
Interventions
- BIOLOGICAL
-
VE800
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.
- DRUG
-
Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
- DRUG
-
Vancomycin Oral Capsule
Vancomycin is an antibiotic used to treat or prevent infection.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Vedanta Biosciences, Inc.
lead INDUSTRY
Principal Investigators
-
Judy Wang, MD · SCRI - Florida Cancer Specialists - Sarasota Cattlemen Office (Coordinating Investigator)
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-01-23
- Primary Completion
- 2021-08-26
- Completion
- 2023-02-23
- FDA Drug
- Yes
Countries
- United States
Study Locations
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