This study evaluated the safety and efficacy of VE800 in combination with nivolumab in patients with selected types of advanced or metastatic cancer
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
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.
Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Vancomycin is an antibiotic used to treat or prevent infection.
HonorHealth Research Institute
Scottsdale, Arizona, United States
University of California Los Angeles
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Safety and tolerability of VE800 in combination with nivolumab: Number of Participants with Adverse Events
Time frame: From the first dose to the last dose (up to 56.7 weeks), plus 100 days of post-treatment follow-up
Objective Response Rate (ORR)
Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: 18 months (first patient enrolled to last patient visit completed)
Duration of Response (DOR)
Defined as the time from first documentation of complete response (CR) or partial response (PR) until the time of first documentation of progressive disease (PD) according to RECIST 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Up to two years
Best Overall Response
Best response among all overall responses from cycle 1 day 1 (C1D1) until disease progression or start of new anticancer therapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Up to 2 years
Disease Control Rate (DCR)
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Los Angeles, California, United States
Pacific Hematology Oncology Associates
San Francisco, California, United States
The Angeles Clinic and Research Institute - West Los Angeles Office
Santa Monica, California, United States
University of California Los Angeles
Santa Monica, California, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
The University of Chicago
Chicago, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Washington University School of Medicine Siteman Cancer Center
St Louis, Missouri, United States
...and 8 more locations
The percentage of patients who have achieved complete response (CR), partial response (PR), or stable disease (SD) from cycle 1 day 1 (C1D1) until disease progression (DP) or start of new anticancer therapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Up to 2 years
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) is defined as the time from start of treatment to the earlier date of assessment of progression or death by any cause in the absence of progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time frame: From the first dose to the last dose (up to 56.7 weeks), plus 100 days of post-treatment follow-up and then follow-up for survival every 90 days.
Overall Survival (OS)
Overall Survival (OS) as measured from the date of start of treatment to the date of death by any cause will also be evaluated.
Time frame: 18 months (first patient enrolled to last patient visit completed)
Detection of VE800 Bacterial Strain Colonization in Stool
Detection of VE800 bacterial strain colonization in stool was measured by pharmacokinetics (PK) of VE800
Time frame: 18 months (first patient enrolled to last patient visit completed)
Degree of VE800 Bacterial Strain Colonization in Stool
Measured by pharmacokinetics (PK) of VE800 colonization in stool
Time frame: 18 months (first patient enrolled to last patient visit completed)
Duration of VE800 Bacterial Strain Colonization in Stool
Measured by pharmacokinetics (PK) of VE800 colonization in stool
Time frame: 18 months (first patient enrolled to last patient visit completed)