Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 111
Summary
- Conditions
- Colorectal Cancer
- Gastric Cancer
- Gastroesophageal Junction Adenocarcinoma
- Melanoma
- Metastatic Cancer
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: This study design will help determine how safe and effective the study drug, VE800, in combination with nivolumab in patients with advanced/metastatic cancer. The following cohorts of patients with advanced/metastatic cancer will be enrolled: Melanoma Gastric/gastroesophageal junction (GEJ) adenocarcinoma Colorectal cancer (microsatellite-stable) (CRC-MSS) Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
CONSORTIUM-IO is a first-in-human multicenter, open-label study, where it's main objectives will evaluate: Safety and tolerability of VE800 in combination with Nivolumab Efficacy as measured by a total of overall response rate. The study will enroll approximately 111 patients with melanoma, patients...
CONSORTIUM-IO is a first-in-human multicenter, open-label study, where it's main objectives will evaluate: Safety and tolerability of VE800 in combination with Nivolumab Efficacy as measured by a total of overall response rate. The study will enroll approximately 111 patients with melanoma, patients with gastric/gastroesophageal junction (GEJ) adenocarcinoma, and patients with microsatellite-stable (MSS) colorectal cancer (CRC). Nivolumab is an already approved by the FDA (the U.S. Food and Drug Administration), however, it is not approved for the study cancer indications. VE800 is the investigational product and alive VE800 bacterial consortium were designed to elicit an immune response.
Tracking Information
- NCT #
- NCT04208958
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Not Provided
Get Well Soon