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Clinical 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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04208958
Study type Interventional
Source Vedanta Biosciences, Inc.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date January 23, 2020
Completion date February 23, 2023

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