Trials / Completed
CompletedNCT04208958
Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer
Phase 1 Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- Vedanta Biosciences, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluated the safety and efficacy of VE800 in combination with nivolumab in patients with selected types of advanced or metastatic cancer
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 | 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. |
Timeline
- Start date
- 2020-01-23
- Primary completion
- 2021-08-26
- Completion
- 2023-02-23
- First posted
- 2019-12-23
- Last updated
- 2025-10-27
- Results posted
- 2023-08-29
Locations
18 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04208958. Inclusion in this directory is not an endorsement.