How do you keep fighting when the strongest therapies stop working? When the strongest therapies fail, research opens the door to new options. This research study looks at a bold new way to give the immune system another chance to fight.

The Hemopurifier® is a filter created to capture and remove harmful particles called extracellular vesicles, tiny messengers released by the tumour that help cancer hide and spread. By clearing them from the blood, researchers aim to lift the barriers that keep immunotherapy from working at its best. This study will test whether this approach is safe and can go beyond the 30–40% response of existing treatments like Pembrolizumab or Nivolumab.

This study may open new doors and possibilities. Take the step and join today.

• Receive the investigational Hemopurifier® treatment together with your current immunotherapy (Keytruda® or Opdivo®), all at no additional costs to your regular care.
• Join one of three study cohorts, where you’ll receive 2 to 3 Hemopurifier® sessions in a one week period before your next scheduled dose of immunotherapy.
• Be reimbursed for travel and lodging.
• Help test a new approach that may strengthen how the immune system fights cancer.
• Contribute to research that could improve treatment options and outcomes for future cancer patients.

• You will receive a detailed outline of all details of the study, including treatment, risks, and procedures, and you will be given the chance to ask study staff questions before you decide whether to participate.
• If you decide to participate in the study and later feel that you no longer wish to be part of it, you can withdraw at any time
• Your records relating to this study and any other information received will be kept strictly confidential, except as required by the law.

Eligible:

• Adults aged 18 and above who are diagnosed with one of these cancers:
  • Non-small cell lung cancer
  • Melanoma
  • Bladder or urinary tract cancer
  • Kidney cancer
  • Colorectal cancer (MSI-H or dMMR)
  • Stomach or gastr-oesophageal junction cancer
  • Oesophageal cancer
  • Head and neck cancer
  • Cervical cancer
  • Mesothelioma.
• Currently receiving treatment with Keytruda® (pembrolizumab) or Opdivo® (nivolumab), with recent scans showing the cancer is stable or growing.
• Able to carry out normal activities with little or some limitations (such as doing light work or household tasks).
• Willing to use effective birth control during the study and for about 4 months after (if applicable).
• Able to attend the required study visits, including:
  • A screening period (up to 28 days)
  • Hemopurifier® treatment sessions before the next scheduled dose of immunotherapy one to three treatments (4 hour long treatments) over a 1 week period.
  • A safety follow-up visit 28 days later, and follow-up visits for up to 1 year.

Ineligible:

• Adults who:
  • Have cancer that has spread to the brain or the lining around the brain
  • Have certain immune system conditions, autoimmune disorders requiring strong medications in the past year, or are being treated for non-infectious lung inflammation
  • Have tested positive for HIV, hepatitis B, or hepatitis C
  • Cannot take full blood-thinning treatments during the Hemopurifier treatment
  • Are currently pregnant, planning pregnancy, or breastfeeding
  • Have had an allergic reaction to heparin or a serious blood reaction called heparin-induced thrombocytopenia
  • Would not be willing to receive a blood transfusion if needed
  • Have had a solid organ transplant (such as kidney, liver, heart, or lung)
  • Are currently in another clinical trial

This study has been reviewed and approved by the Royal Adelaide Hospital Ethics Committee and Belberry Ethics Committee for Genesis/Royal North Shore Hospital and Pindara Private Hospital

Hospital Site: Royal Adelaide Hospital – Cancer Clinical Trials Unit
Location: Royal Adelaide Hospital, Port Road, Adelaide SA 5000

Hospital Site: Pindara Private Hospital
Location: Allchurch Avenue, Benowa, QLD 4217

This research study is taking place in several locations. To see if there is a research site near you, please see below.