Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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

Official Title

Phase 1 Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer

Details

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.

Keywords

Metastatic Cancer Melanoma Gastric Cancer Gastroesophageal Junction Adenocarcinoma Colorectal Cancer VE800 Nivolumab Opdivo GEJ Adenocarcinoma CRC-MSS Vedanta BMS Colorectal Neoplasms Adenocarcinoma Stomach Neoplasms Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Esophageal Neoplasms Vancomycin Vancomycin Oral Capsule

Eligibility

For people ages 18 years and up

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

Locations

  • University of California Los Angeles
    Los Angeles California 90095 United States
  • University of California Los Angeles
    Santa Monica California 90404 United States
  • Pacific Hematology Oncology Associates
    San Francisco California 94115 United States
  • The Angeles Clinic and Research Institute - West Los Angeles Office
    Santa Monica California 90404 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Vedanta Biosciences, Inc.
ID
NCT04208958
Phase
Phase 1/2
Study Type
Interventional
Last Updated