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

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ClinicalTrials.gov Identifier: NCT04208958
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : December 4, 2020
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Vedanta Biosciences, Inc.

Tracking Information
First Submitted Date  ICMJE December 16, 2019
First Posted Date  ICMJE December 23, 2019
Last Update Posted Date December 4, 2020
Actual Study Start Date  ICMJE January 23, 2020
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2019)
  • 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
  • Evaluate clinical activity [ Time Frame: From the first dose to 100 days after the last dose ]
    Will be measured as objective response rate (ORR)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2019)
  • Duration of response (DOR) [ Time Frame: From the first dose to 100 days after the last dose ]
    Evaluation of clinical benefit
  • Best Overall Response [ Time Frame: From the first dose to 100 days after the last dose ]
    Evaluation of clinical benefit
  • Disease Control Rate (DCR) [ Time Frame: From the first dose to 100 days after the last dose ]
    Evaluation of clinical benefit
  • Progression-Free Survival (PFS) [ Time Frame: From the first dose to 100 days after the last dose ]
    Evaluation of clinical benefit
  • Overall Survival (OS) [ Time Frame: From the first dose to 100 days after the last dose ]
    Evaluation of clinical benefit
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer
Official Title  ICMJE Phase 1 Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Metastatic Cancer
  • Melanoma
  • Gastric Cancer
  • Gastroesophageal Junction Adenocarcinoma
  • Colorectal Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Biological: VE800
  • Drug: Nivolumab
  • Drug: Vancomycin Oral Capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 19, 2019)		 111
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lorraine Hughes 857-706-1427 ConsortiumIO-ctinquiries@vedantabio.com
Contact: Maria Kim 857-706-1427 ConsortiumIO-ctinquiries@vedantabio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04208958
Other Study ID Numbers  ICMJE VE800-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Vedanta Biosciences, Inc.
Study Sponsor  ICMJE Vedanta Biosciences, Inc.
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE Not Provided
PRS Account Vedanta Biosciences, Inc.
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP