What is the HyperAcute® Pancreas Immunotherapy Clinical Trial?
It is believed that in cancer patients, the body’s immune system does not always recognize tumor cells as “foreign invaders” and therefore does not protect the body against them. HyperAcute® Pancreas immunotherapy, an investigational treatment which is not yet approved by the Food and Drug Administration, is intended to retrain and/or reset the immune system so that a patient’s tumor cells can be recognized by the immune system as “foreign invaders” and target them for attack.
What would I have to do if I participated in this clinical trial?
Treatment will last approximately 6 to 12 months. You must be willing to have monthly blood samples drawn during this treatment period.
Your physician will discuss with you the standard of care treatment you will receive on this research study. This standard of care treatment will include either chemotherapy alone, or chemotherapy and chemoradiation, based on your specific condition. Once you and your physician have discussed and decided upon the standard of care treatment you will receive, you will be randomized by computer (like a coin flip) to determine if you will receive the HyperAcute® Pancreas immunotherapy or not with your standard of care treatment. You will not receive a placebo on this study. Your physician will discuss this with you further.
In addition, follow-up visits will be scheduled every 3 months for the remaining 36 months after treatment and then every 6 months for the next 2 years for follow-up tests and procedures to evaluate treatment response and side effects.
Your participation in the trial is completely voluntary and if you decide to withdraw from the trial, you may do so at any time. Also, your participation will not cost you any additional money. The investigational treatment is provided at no cost to you. You will not be charged for any lab work, tests or procedures that are done strictly for research purposes.
What are the potential risks of participating in this clinical trial?
It is hard to determine which patients will benefit or which risks, if any, will occur with this investigational treatment.
Risks possibly related to HyperAcute® Pancreas immunotherapy include injection site reactions (redness, swelling, itching) and fatigue. The clinical trial team will review potential benefits and risks with all eligible patients.
Overview of this pancreatic cancer clinical trial.