Bionomics Limited announced that an experimental phase II clinical trial of its cancer drug candidate, BNC105, in combination with Bristol-Myers Squibb's nivolumab, has commenced in patients with metastatic colorectal cancer, in an Australasian Gastro-Intestinal Trials Group (AGITG) sponsored trial supported by Bristol-Myers Squibb. The MODULATE trial will investigate whether BNC105, a vascular disrupting agent, combined with an immune oncology drug, nivolumab, can be used to treat advanced colorectal cancer patients who have exhausted other treatment options. This will be the first clinical assessment of BNC105 in combination with an immunotherapy agent. The Australasian Gastro-Intestinal Trials Group is conducting the MODULATE trial to evaluate new experimental approaches to immunotherapy treatment in colorectal cancer patients. Approximately 45 patients will receive BNC105 and PD-1 inhibitor nivolumab. A second group of approximately 45 patients will receive nivolumab in combination with a Signal Transduction Activator of Transcription (STAT3) inhibitor. The trial is open to recruitment at clinical oncology sites around Australia and the first patient first visit was conducted on 21 September. Immunotherapy is a promising treatment for a number of cancers and uses the patient's own immune system to target and attack the cancer tumour. It works by stimulating lymphocytes, a type of white blood cell, which have infiltrated the tumour. The MODULATE trial aims to investigate whether BNC105 as a vascular disrupting agent that damages the tumour blood vessels leading to changes in the tumor microenvironment, will encourage lymphocytes to enter the tumour, and provide a new treatment option for patients with colorectal cancer. The administration of BNC105 with anti-PD-1 antibodies in mice bearing tumors comprising of colon adenocarcinoma cells has led to a synergistic reduction in tumour size. Bionomics announced that this trial, evaluating the combination of BNC105 and the checkpoint inhibitor nivolumab, has been initiated.