Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
Study NCT ID:
NCT04208958
Status:
COMPLETED
Last Update Posted:
2025-10-27
First Post:
2019-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer
Sponsor:
Vedanta Biosciences, Inc.
Organization:
Study Overview
Official Title:
Phase 1 Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ConsortiumIO
Brief 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.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: