Clinical Trial to Investigate Vaccine/Immunotherapy Combo Treatment for Metastatic Colorectal Cancer
An investigational anti-cancer vaccine will be paired with nivolumab to determine whether the combination therapy will improve survival in patients with the disease.
A new clinical trial will investigate a combination therapy including an anti-cancer vaccine and an immunotherapy to target metastatic colorectal cancer, according to a press release. The trial addresses an unmet need for new therapies aimed at preventing disease recurrence for patients with colorectal cancer.
The researchers, from Rutgers Cancer Institute, are exploring whether the combination therapy will prompt a patient’s immune system to attack their cancer and improve survival.
According to the press release, the investigational vaccine therapy is a newer version of a poxvirus-based cancer treatment previously called PANVAC, which was deemed safe after being tested in more than 15 clinical trials. Given by injection, PANVAC works to stimulate the immune system against infection to target tumor cells that produce specific proteins. The newer version, now called CV301, has undergone changes for improvement.
“CV301 is an exciting choice as the vaccine to partner with nivolumab, as its former version (PANVAC) has shown activity previously in this patient population,” lead investigator Darren R Carpizo, MD, PhD, director of the Liver Cancer and Bile Duct Cancer Program at Rutgers Cancer Institute, said in the press release.
CV301 targets 2 tumor-associated antigens, CEA and MUC1, which are overexpressed in multiple solid tumors, including lung, bladder, and colorectal cancer. According to the press release, CV301 is an “off the shelf” vaccine, which utilizes a prime/boost dosing schedule. It incorporates a modified version of vaccinia as a priming dose, followed by multiple fowlpox boosts, and encodes the TRICOM costimulatory molecules.
For the trial, CV301 will be paired with nivolumab, an FDA-approved drug that treats other forms of cancer, including melanoma, lung cancer, and Hodgkin lymphoma.
To be eligible, patients must be 18 and older with colorectal cancer that has spread to the liver and can be removed by surgery. Patients will be divided randomly into 2 groups. In 1 group, patients will receive nivolumab and the standard chemotherapy. In the second group, patients will receive chemotherapy treatment, surgery, nivolumab, and the CV301 vaccine treatment.
The vaccine treatment will be injected into the fatty part of the skin at multiple intervals prior to and after surgery. Following completion of treatment, patients will be followed by their health care team and undergo a physical exam, bloodwork, and other testing on a regular basis over a 5-year period.
“Immunotherapy drugs known as ‘checkpoint inhibitors’ have already made a significant impact in the treatment of several cancers, but only a minority of patients respond to them,” Dr Carpizo said in the press release. “Combining these drugs with other forms of immunotherapy such as vaccines (as designed in this trial) has the potential to increase the number of patients who benefit from them.”
Exploring a New Treatment for Metastatic Colorectal Cancer [news release]. Rutgers Cancer Institute’s website. http://www.cinj.org/exploring-new-treatment-metastatic-colorectal-cancer. Accessed June 20, 2018.