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Immunomodulator
VE800 combination treatment with nivolumab for Melanoma (ConsortiumIO Trial)
Phase 1 & 2
Waitlist Available
Led By Judy Wang, MD
Research Sponsored by Vedanta Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
ConsortiumIO Trial Summary
This trial will study if adding VE800 to the drug nivolumab could help treat patients with certain types of advanced cancer.
Eligible Conditions
- Cancer
- Melanoma
- Stomach Cancer
- Gastroesophageal Junction Adenocarcinoma
- Colorectal Cancer
ConsortiumIO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to two years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to two years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR)
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Secondary outcome measures
Best Overall Response
Degree of VE800 Bacterial Strain Colonization in Stool
Detection of VE800 Bacterial Strain Colonization in Stool
+5 moreConsortiumIO Trial Design
1Treatment groups
Experimental Treatment
Group I: VE800 combination treatment with nivolumabExperimental Treatment3 Interventions
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VE800
2020
Completed Phase 2
~60
Nivolumab
FDA approved
Vancomycin
FDA approved
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Who is running the clinical trial?
Vedanta Biosciences, Inc.Lead Sponsor
6 Previous Clinical Trials
1,148 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,639 Previous Clinical Trials
4,128,976 Total Patients Enrolled
177 Trials studying Melanoma
57,487 Patients Enrolled for Melanoma
Judy Wang, MDPrincipal InvestigatorSCRI - Florida Cancer Specialists - Sarasota Cattlemen Office (Coordinating Investigator)
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