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

Sponsor
Vedanta Biosciences, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04208958
Collaborator
Bristol-Myers Squibb (Industry)
54
Enrollment
18
Locations
1
Arm
30.3
Anticipated Duration (Months)
3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Actual Enrollment :
54 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)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 :
Jan 23, 2020
Anticipated Primary Completion Date :
Jul 1, 2021
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

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 Names:
  • Opdivo

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety and tolerability of VE800 in combination with nivolumab: incidence of adverse events [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 [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) [From the first dose to 100 days after the last dose]

      Evaluation of clinical benefit

    2. Best Overall Response [From the first dose to 100 days after the last dose]

      Evaluation of clinical benefit

    3. Disease Control Rate (DCR) [From the first dose to 100 days after the last dose]

      Evaluation of clinical benefit

    4. Progression-Free Survival (PFS) [From the first dose to 100 days after the last dose]

      Evaluation of clinical benefit

    5. Overall Survival (OS) [From the first dose to 100 days after the last dose]

      Evaluation of clinical benefit

    6. Detection of VE800 bacterial strain colonization in stool [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 [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 [From the first dose to 100 days after the last dose]

      Measured by pharmacokinetics (PK) of VE800colonization in stool

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 HonorHealth Research Institute Scottsdale Arizona United States 85258
    2 University of California Los Angeles Los Angeles California United States 90095
    3 Pacific Hematology Oncology Associates San Francisco California United States 94115
    4 The Angeles Clinic and Research Institute - West Los Angeles Office Santa Monica California United States 90404
    5 University of California Los Angeles Santa Monica California United States 90404
    6 Florida Cancer Specialists Sarasota Florida United States 34232
    7 Moffitt Cancer Center Tampa Florida United States 33612
    8 The University of Chicago Chicago Illinois United States 60637
    9 Indiana University Melvin and Bren Simon Cancer Center Indianapolis Indiana United States 46202
    10 Washington University School of Medicine Siteman Cancer Center Saint Louis Missouri United States 63110
    11 John Theurer Cancer Center Hackensack New Jersey United States 07601
    12 New York University Medical Oncology Associates New York New York United States 10016
    13 Weill Cornell Medicine New York New York United States 10065
    14 UPMC Hillman Cancer Center Pittsburgh Pennsylvania United States 15232
    15 The Miriam Hospital Providence Rhode Island United States 02906
    16 Baylor Scott and White Center for Advanced Heart and Lung Disese Dallas Texas United States 75246
    17 Huntsman Cancer Institute and Hospital Salt Lake City Utah United States 84112
    18 Swedish Medical Oncology - First Hill Seattle Washington United States 98104

    Sponsors and Collaborators

    • Vedanta Biosciences, Inc.
    • Bristol-Myers Squibb

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vedanta Biosciences, Inc.
    ClinicalTrials.gov Identifier:
    NCT04208958
    Other Study ID Numbers:
    • VE800-001
    First Posted:
    Dec 23, 2019
    Last Update Posted:
    Jun 23, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Colorectal Neoplasms
    Melanoma
    Adenocarcinoma
    Stomach Neoplasms
    Neoplasm Metastasis
    Neoplasms
    Neoplasms, Second Primary
    Esophageal Neoplasms
    Vancomycin
    Nivolumab

    Study Results

    No Results Posted as of Jun 23, 2021