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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Vedanta Biosciences, Inc.
Study ID
NCT04208958
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VE800 — BIOLOGICAL
    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.
  • Nivolumab — DRUG
    Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
  • Vancomycin Oral Capsule — DRUG
    Vancomycin is an antibiotic used to treat or prevent infection.

Study Details

This study evaluated the safety and efficacy of VE800 in combination with nivolumab in patients with selected types of advanced or metastatic cancer

Key Dates

Start date
Jan 23, 2020
Status verified
Mar 2023
Primary completion
Aug 26, 2021
Completion
Feb 23, 2023

Study Design

Enrollment
56 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

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 ]

Locations (18)

FacilityCityStateZIPSite coordinators
HonorHealth Research InstituteScottsdaleArizona85258-
University of California Los AngelesLos AngelesCalifornia90095-
Pacific Hematology Oncology AssociatesSan FranciscoCalifornia94115-
The Angeles Clinic and Research Institute - West Los Angeles OfficeSanta MonicaCalifornia90404-
University of California Los AngelesSanta MonicaCalifornia90404-
Florida Cancer SpecialistsSarasotaFlorida34232-
Moffitt Cancer CenterTampaFlorida33612-
The University of ChicagoChicagoIllinois60637-
Indiana University Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-
Washington University School of Medicine Siteman Cancer CenterSt LouisMissouri63110-
John Theurer Cancer CenterHackensackNew Jersey07601-
New York University Medical Oncology AssociatesNew YorkNew York10016-
Weill Cornell MedicineNew YorkNew York10065-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-
The Miriam HospitalProvidenceRhode Island02906-
Baylor Scott and White Center for Advanced Heart and Lung DiseseDallasTexas75246-
Huntsman Cancer Institute and HospitalSalt Lake CityUtah84112-
Swedish Medical Oncology - First HillSeattleWashington98104-

Find similar trials in Scottsdale, AZ

By condition
Colorectal cancerGastric cancerMelanoma
By specialty
OncologyGI oncologySkin cancerDermatology
By research site
HonorHealth Research Institute· Scottsdale, AZUniversity of California Los Angeles· Los Angeles, CAPacific Hematology Oncology Associates· San Francisco, CAThe Angeles Clinic and Research Institute - West Los Angeles Office· Santa Monica, CAUniversity of California Los Angeles· Santa Monica, CAFlorida Cancer Specialists· Sarasota, FL

Related Studies