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

  • STATUS
    Recruiting
  • End date
    Apr 26, 2022
  • participants needed
    111
  • sponsor
    Vedanta Biosciences, Inc.
Updated on 5 May 2021
antibiotics
cancer
systemic therapy
measurable disease
metastasis
nivolumab
cancer treatment
alopecia

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

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.

Details
Condition Colorectal Cancer, Rectal disorder, Metastasis, melanoma, skin cancer, Gastropathy, Gastric Cancer, Stomach Discomfort, Metastatic Melanoma, Liver Metastases, Bone Metastases, Colon Cancer Screening, Rectal Disorders, Colon cancer; rectal cancer, Brain Metastases, Gastroesophageal Junction Adenocarcinoma, Adenocarcinoma of the Gastroesophageal Junction, Gastric Carcinoma, Cancer, Metastatic, Malignant Melanoma, Stomach Cancer, Metastatic Cancer, Neoplasm Metastasis, colorectal neoplasm, gastric cancers, colorectal cancers, cancers metastatic, cancer, colorectal, colorectal tumor, tumors, colorectal, metastases, metastatic disease, secondary cancer, secondaries, metastatic tumor, metastasized
Treatment Nivolumab, Vancomycin Oral Capsule, VE800
Clinical Study IdentifierNCT04208958
SponsorVedanta Biosciences, Inc.
Last Modified on5 May 2021

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