Amazon and Fred Hutchinson Cancer Center recently launched an early-phase clinical trial to assess the safety and efficacy of a cancer vaccine in the treatment of patients with late-stage skin cancer or hormone receptor-positive, HER2-negative breast cancer.
Representatives from Fred Hutchinson Cancer Center confirmed to CURE® that the Seattle-based cancer center has partnered with Amazon in an ongoing early-phase clinical trial investigating the safety and efficacy of a cancer vaccine.
The plan, according to a filing on ClinicalTrials.gov, is to enroll 20 patients onto the phase 1 clinical trial. Patients enrolled onto the trial must have stage 3c to 4 melanoma, or hormone receptor-positive, HER2-negative breast cancer that has spread (or metastasized) to other parts of the body.
Of note, ClinicalTrials.gov is a web-based resource hosted by the National Library of Medicine at the National Institutes of Health that acts as a registry of clinical trials.
Patients will receive a personalized vaccine, along with a poly-ICLC. According to information from the National Cancer Institute, a poly-ICLC is a substance being investigated in the treatment of cancer and it has the ability to stimulate the immune system.
The filing noted that patients will be given the poly-ICLC once a week during weeks when they are not receiving the vaccine. Two weeks after the first dose of poly-ICLC, patients will then receive the vaccine every four weeks. Additionally, they will be administered Opdivo (nivolumab) every two or four weeks.
According to the filing, treatment will continue for 25 weeks unless disease progression or unacceptable toxicity occurs first. If patients have continued to derive a benefit from that treatment, they will continue to receive Opdivo as a maintenance therapy every two or four weeks up to 12 months. A maintenance treatment is given to patients to prevent disease recurrence or progression after the primary treatment has been completed.
The investigators will then follow-up with the patients at 24, 36 and 48 weeks to monitor the safety and efficacy of treatment.
The main goal of the early-phase cancer vaccine trial is to determine the number of side effects within one year of a patient’s first vaccination. Other goals include, but are not limited to, analyzing the best overall response to treatment and progression-free survival (which is the time a patient is alive without their disease getting worse).
The estimated completion date for the study is November 1, 2023.
There have been several updates on clinical trials investigating cancer vaccines this year. In May, investigators launched a study to evaluate Vaxinia — a novel cancer vaccine — in patients with previously treated advanced solid tumors. Additionally, interim study results released by Nykode Therapeutics AS showed that treatment with a combination of an investigational cancer vaccine and Tecentriq (atezolizumab) conferred promising outcomes in patients with heavily pre-treated HPV16-positive advanced cervical cancer.
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