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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04208958
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : June 16, 2020
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Vedanta Biosciences, Inc.

Brief Summary:
This study will evaluate the safety and efficacy of VE800 in combination with Nivolumab in patients with selected types of advanced or metastatic cancer

Condition or disease Intervention/treatment Phase
Metastatic Cancer Melanoma Gastric Cancer Gastroesophageal Junction Adenocarcinoma Colorectal Cancer Biological: VE800 Drug: Nivolumab Drug: Vancomycin Oral Capsule Phase 1 Phase 2

Detailed Description:

CONSORTIUM-IO is a first-in-human multicenter, open-label study, where it's main objectives will evaluate:

  • Safety and tolerability of VE800 in combination with Nivolumab
  • Efficacy as measured by a total of overall response rate.

The study will enroll approximately 111 patients with melanoma, patients with gastric/gastroesophageal junction (GEJ) adenocarcinoma, and patients with microsatellite-stable (MSS) colorectal cancer (CRC).

Nivolumab is an already approved by the FDA (the U.S. Food and Drug Administration), however, it is not approved for the study cancer indications. VE800 is the investigational product and alive VE800 bacterial consortium were designed to elicit an immune response.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 111 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

This study design will help determine how safe and effective the study drug, VE800, in combination with nivolumab in patients with advanced/metastatic cancer.

The following cohorts of patients with advanced/metastatic cancer will be enrolled:

  • Melanoma
  • Gastric/gastroesophageal junction (GEJ) adenocarcinoma
  • Colorectal cancer (microsatellite-stable) (CRC-MSS)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer
Actual Study Start Date : January 23, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : April 2022


Arm Intervention/treatment
Experimental: VE800 combination treatment with Nivolumab
Subjects will receive 5 days of oral vancomycin, followed by daily VE800 in combination with Nivolumab every 4 weeks.
Biological: VE800
VE800 is an orally administered (PO) live biotherapeutic product (LBP) consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.

Drug: Nivolumab
Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
Other Name: Opdivo

Drug: Vancomycin Oral Capsule
Vancomycin is an antibiotic used to treat or prevent infection.
Other Name: Vancoccin




Primary Outcome Measures :
  1. Safety and tolerability of VE800 in combination with nivolumab: incidence of adverse events [ Time Frame: From the first dose to 100 days after the last dose ]
    Will be measured in terms of incidence of adverse events

  2. Evaluate clinical activity [ Time Frame: From the first dose to 100 days after the last dose ]
    Will be measured as objective response rate (ORR)


Secondary Outcome Measures :
  1. Duration of response (DOR) [ Time Frame: From the first dose to 100 days after the last dose ]
    Evaluation of clinical benefit

  2. Best Overall Response [ Time Frame: From the first dose to 100 days after the last dose ]
    Evaluation of clinical benefit

  3. Disease Control Rate (DCR) [ Time Frame: From the first dose to 100 days after the last dose ]
    Evaluation of clinical benefit

  4. Progression-Free Survival (PFS) [ Time Frame: From the first dose to 100 days after the last dose ]
    Evaluation of clinical benefit

  5. Overall Survival (OS) [ Time Frame: From the first dose to 100 days after the last dose ]
    Evaluation of clinical benefit

  6. Detection of VE800 bacterial strain colonization in stool [ Time Frame: From the first dose to 100 days after the last dose ]
    Measured by pharmacokinetics (PK) of VE800

  7. Degree of VE800 bacterial strain colonization in stool [ Time Frame: From the first dose to 100 days after the last dose ]
    Measured by pharmacokinetics (PK) of VE800colonization in stool

  8. Duration of VE800 bacterial strain colonization in stool [ Time Frame: From the first dose to 100 days after the last dose ]
    Measured by pharmacokinetics (PK) of VE800colonization in stool



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208958


Contacts
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Contact: Lorraine Hughes 857-706-1427 ConsortiumIO-ctinquiries@vedantabio.com
Contact: Maria Kim 857-706-1427 ConsortiumIO-ctinquiries@vedantabio.com

Locations
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United States, California
The Angeles Clinic and Research Institute - West Los Angeles Office Recruiting
Santa Monica, California, United States, 90404
Contact: Helen Berroya    310-231-2111    hberroya@theangelesclinic.org   
Principal Investigator: Omid Hamid, MD         
United States, Florida
Florida Cancer Specialists Recruiting
Sarasota, Florida, United States, 34232
Contact: Nancy Olsen    941-377-9993 ext 7247    nolsen@flcancer.com   
Principal Investigator: Judy Wang, MD         
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Anne Younger, RN    317-274-0951    anefoste@iupui.edu   
Principal Investigator: Anita Turk, MD         
United States, New Jersey
John Theurer Cancer Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Chelsea McCabe    551-996-4725    Chelsea.McCabe@hackensackmeridian.org   
Principal Investigator: Martin Gutierrez, MD         
United States, Pennsylvania
UPMC Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Aaron Vannatter    412-623-2943    vannattera@upmc.edu   
Principal Investigator: Diwakar Davar, MD         
United States, Washington
Swedish Medical Oncology - First Hill Recruiting
Seattle, Washington, United States, 98104
Contact: Neil Bailey    206-386-2310    neil.bailey@swedish.org   
Principal Investigator: Philip Gold, MD         
Sponsors and Collaborators
Vedanta Biosciences, Inc.
Bristol-Myers Squibb
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Responsible Party: Vedanta Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT04208958    
Other Study ID Numbers: VE800-001
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vedanta Biosciences, Inc.:
Metastatic Cancer
VE800
Nivolumab
Opdivo
Melanoma
Gastric Cancer
Gastroesophageal Junction Adenocarcinoma
GEJ Adenocarcinoma
Colorectal Cancer
CRC-MSS
Vedanta
BMS
Additional relevant MeSH terms:
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Melanoma
Colorectal Neoplasms
Adenocarcinoma
Stomach Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Esophageal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Stomach Diseases
Neoplastic Processes
Pathologic Processes
Head and Neck Neoplasms
Esophageal Diseases