Clinical Trials /

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

NCT04208958

Description:

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

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer
  • Official Title: Phase 1 Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer

Clinical Trial IDs

  • ORG STUDY ID: VE800-001
  • NCT ID: NCT04208958

Conditions

  • Metastatic Cancer
  • Melanoma
  • Gastric Cancer
  • Gastroesophageal Junction Adenocarcinoma
  • Colorectal Cancer

Interventions

DrugSynonymsArms
VE800VE800 combination treatment with Nivolumab
NivolumabOpdivoVE800 combination treatment with Nivolumab
Vancomycin Oral CapsuleVancoccinVE800 combination treatment with Nivolumab

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
VE800 combination treatment with NivolumabExperimentalSubjects will receive 5 days of oral vancomycin, followed by daily VE800 in combination with Nivolumab every 4 weeks.
  • VE800
  • Nivolumab
  • Vancomycin Oral Capsule

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:Will be measured in terms of incidence of adverse events

Secondary Outcome Measures

Measure:Duration of response (DOR)
Time Frame:From the first dose to 100 days after the last dose
Safety Issue:
Description:Evaluation of clinical benefit
Measure:Best Overall Response
Time Frame:From the first dose to 100 days after the last dose
Safety Issue:
Description:Evaluation of clinical benefit
Measure:Disease Control Rate (DCR)
Time Frame:From the first dose to 100 days after the last dose
Safety Issue:
Description:Evaluation of clinical benefit
Measure:Progression-Free Survival (PFS)
Time Frame:From the first dose to 100 days after the last dose
Safety Issue:
Description:Evaluation of clinical benefit
Measure:Overall Survival (OS)
Time Frame:From the first dose to 100 days after the last dose
Safety Issue:
Description:Evaluation of clinical benefit
Measure:Detection of VE800 bacterial strain colonization in stool
Time Frame:From the first dose to 100 days after the last dose
Safety Issue:
Description:Measured by pharmacokinetics (PK) of VE800
Measure:Degree of VE800 bacterial strain colonization in stool
Time Frame:From the first dose to 100 days after the last dose
Safety Issue:
Description:Measured by pharmacokinetics (PK) of VE800colonization in stool
Measure:Duration of VE800 bacterial strain colonization in stool
Time Frame:From the first dose to 100 days after the last dose
Safety Issue:
Description:Measured by pharmacokinetics (PK) of VE800colonization in stool

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Vedanta Biosciences, Inc.

Trial Keywords

  • Metastatic Cancer
  • VE800
  • Nivolumab
  • Opdivo
  • Melanoma
  • Gastric Cancer
  • Gastroesophageal Junction Adenocarcinoma
  • GEJ Adenocarcinoma
  • Colorectal Cancer
  • CRC-MSS
  • Vedanta
  • BMS

Last Updated

January 2, 2020