search
Back to results

Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer (ConsortiumIO)

Primary Purpose

Metastatic Cancer, Melanoma, Gastric Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VE800
Nivolumab
Vancomycin Oral Capsule
Sponsored by
Vedanta Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Cancer focused on measuring Metastatic Cancer, VE800, Nivolumab, Opdivo, Melanoma, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, GEJ Adenocarcinoma, Colorectal Cancer, CRC-MSS, Vedanta, BMS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Partial Inclusion Criteria:

  • Patients with advanced or metastatic cancer who have received no more than 3 lines of prior systemic therapy for advanced/metastatic disease.
  • Histologically diagnosed advanced (unresectable) or metastatic cancer with at least one measurable lesion as per RECIST 1.1
  • Tumor lesions amenable for biopsy, if deemed safe by the investigator
  • Toxicity from prior cancer therapy should resolve to CTCAE Grade ≤ 1 (excluding alopecia and neuropathy, where up to Grade 2 residual is allowed)

Partial Exclusion Criteria:

  • Prior treatment with immune checkpoint inhibitor (iCPI) (Note: this criterion does not apply to patients with melanoma)
  • Receipt of any conventional or investigational systemic anti-cancer therapy within 26 days prior to the start of study treatment
  • Concurrent chemotherapy, immunotherapy, biologic, or hormonal anti-cancer therapy. Agents such as bisphosphonates or denosumab are acceptable as prophylaxis for bone metastasis.
  • Patients must not have received a transfusion (platelets or red blood cells) within 4 weeks of the first dose of study treatment
  • Patients with an active, known or suspected autoimmune disease. Patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin not requiring systemic treatment are permitted to enroll.
  • Patients with known active hepatitis (e.g., hepatitis B or C) NOTE: Patients with previously treated hepatitis B or C are permitted to enroll if there is evidence of documented resolution of infection.
  • Received a fecal transplant, spore or other preparation of fecal material, isolated bacterial products, genetically modified bacteria, or VE800

Sites / Locations

  • HonorHealth Research Institute
  • University of California Los Angeles
  • Pacific Hematology Oncology Associates
  • The Angeles Clinic and Research Institute - West Los Angeles Office
  • University of California Los Angeles
  • Florida Cancer Specialists
  • Moffitt Cancer Center
  • The University of Chicago
  • Indiana University Melvin and Bren Simon Cancer Center
  • Washington University School of Medicine Siteman Cancer Center
  • John Theurer Cancer Center
  • New York University Medical Oncology Associates
  • Weill Cornell Medicine
  • UPMC Hillman Cancer Center
  • The Miriam Hospital
  • Baylor Scott and White Center for Advanced Heart and Lung Disese
  • Huntsman Cancer Institute and Hospital
  • Swedish Medical Oncology - First Hill

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VE800 combination treatment with nivolumab

Arm Description

Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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.
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.
Disease Control Rate (DCR)
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.
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
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.
Detection of VE800 Bacterial Strain Colonization in Stool
Detection of VE800 bacterial strain colonization in stool was measured by pharmacokinetics (PK) of VE800
Degree of VE800 Bacterial Strain Colonization in Stool
Measured by pharmacokinetics (PK) of VE800 colonization in stool
Duration of VE800 Bacterial Strain Colonization in Stool
Measured by pharmacokinetics (PK) of VE800 colonization in stool

Full Information

First Posted
December 16, 2019
Last Updated
August 7, 2023
Sponsor
Vedanta Biosciences, Inc.
Collaborators
Bristol-Myers Squibb
search

1. Study Identification

Unique Protocol Identification Number
NCT04208958
Brief Title
Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer
Acronym
ConsortiumIO
Official Title
Phase 1 Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 23, 2020 (Actual)
Primary Completion Date
August 26, 2021 (Actual)
Study Completion Date
February 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vedanta Biosciences, Inc.
Collaborators
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer, Melanoma, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Colorectal Cancer
Keywords
Metastatic Cancer, VE800, Nivolumab, Opdivo, Melanoma, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, GEJ Adenocarcinoma, Colorectal Cancer, CRC-MSS, Vedanta, BMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
This study was designed to help determine the safety and effectiveness of the study drug, VE800, in combination with nivolumab in patients with advanced/metastatic cancer. The following cohorts of patients with advanced/metastatic cancer were enrolled: Melanoma Gastric/gastroesophageal junction (GEJ) adenocarcinoma Colorectal cancer (microsatellite-stable) (CRC-MSS)
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VE800 combination treatment with nivolumab
Arm Type
Experimental
Arm Description
Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks.
Intervention Type
Biological
Intervention Name(s)
VE800
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo
Intervention Description
Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Intervention Type
Drug
Intervention Name(s)
Vancomycin Oral Capsule
Other Intervention Name(s)
Vancocin
Intervention Description
Vancomycin is an antibiotic used to treat or prevent infection.
Primary Outcome Measure Information:
Title
Safety and Tolerability of VE800 in Combination With Nivolumab: Number of Participants With Adverse Events
Description
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
Title
Objective Response Rate (ORR)
Description
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)
Secondary Outcome Measure Information:
Title
Duration of Response (DOR)
Description
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
Title
Best Overall Response
Description
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
Title
Disease Control Rate (DCR)
Description
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
Title
Progression-Free Survival (PFS)
Description
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.
Title
Overall Survival (OS)
Description
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)
Title
Detection of VE800 Bacterial Strain Colonization in Stool
Description
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)
Title
Degree of VE800 Bacterial Strain Colonization in Stool
Description
Measured by pharmacokinetics (PK) of VE800 colonization in stool
Time Frame
18 months (first patient enrolled to last patient visit completed)
Title
Duration of VE800 Bacterial Strain Colonization in Stool
Description
Measured by pharmacokinetics (PK) of VE800 colonization in stool
Time Frame
18 months (first patient enrolled to last patient visit completed)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Partial Inclusion Criteria: Patients with advanced or metastatic cancer who had received no more than 3 lines of prior systemic therapy for advanced/metastatic disease. Histologically diagnosed advanced (unresectable) or metastatic cancer with at least one measurable lesion as per RECIST 1.1 Tumor lesions amenable for biopsy, if deemed safe by the investigator Toxicity from prior cancer therapy should have resolved to Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤ 1 (excluding alopecia and neuropathy, where up to Grade 2 residual was allowed) Partial Exclusion Criteria: Prior treatment with immune checkpoint inhibitor (iCPI) (Note: this criterion did not apply to patients with melanoma) Receipt of any conventional or investigational systemic anti-cancer therapy within 21 days prior to the first dose of vancomycin Concurrent chemotherapy, immunotherapy, biologic, or hormonal anti-cancer therapy. Agents such as bisphosphonates or denosumab were acceptable as prophylaxis for bone metastasis. Patients must not have received a transfusion (platelets or red blood cells) within 4 weeks of the first dose of study treatment Patients with an active, known or suspected autoimmune disease. Patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment were permitted to enroll. Patients with known active hepatitis (e.g., hepatitis B or C) NOTE: Patients with previously treated hepatitis B or C were permitted to enroll if there was evidence of documented resolution of infection. Received a fecal transplant, spore or other preparation of fecal material, isolated bacterial products, genetically modified bacteria, or VE800
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judy Wang, MD
Organizational Affiliation
SCRI - Florida Cancer Specialists - Sarasota Cattlemen Office (Coordinating Investigator)
Official's Role
Principal Investigator
Facility Information:
Facility Name
HonorHealth Research Institute
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Pacific Hematology Oncology Associates
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
The Angeles Clinic and Research Institute - West Los Angeles Office
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
University of California Los Angeles
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Florida Cancer Specialists
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Washington University School of Medicine Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
John Theurer Cancer Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
New York University Medical Oncology Associates
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Baylor Scott and White Center for Advanced Heart and Lung Disese
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Huntsman Cancer Institute and Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Swedish Medical Oncology - First Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer

We'll reach out to this number within 24 hrs