Phase 1 Melanoma Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with advanced melanoma that has spread to other parts of the body, confirmed through a tissue sample (biopsy)
- You are 18 years of age or older at the time of signing the consent form
- Your doctor has planned for you to receive a type of immunotherapy called PD-1 therapy, either alone or combined with another immunotherapy called anti-CTLA-4, as your standard treatment
- You are willing and able to sign a consent form agreeing to take part in the trial
- You have at least one tumour or lesion that is at least 8mm in size and is located on or just under the skin, can be felt by touch, or can be reached safely with an ultrasound-guided needle biopsy
- Your blood test results show that your bone marrow and blood are functioning well enough (specific blood count levels required — confirm with trial site), based on tests taken within the past 45 days
Who may not be able to join:
- Your melanoma started in the eye (uveal) or in a mucous membrane such as the mouth or digestive tract (mucosal melanoma)
- You are pregnant or currently breastfeeding
- You have previously received any drug treatment (other than surgery) for melanoma that has spread
- You have a known immune system disorder, or you are taking steroid medication at a dose higher than 10mg of prednisone per day, or you have taken immune-suppressing medication within the past 7 days
- You have melanoma that has spread to the brain and is causing symptoms, or cancer affecting the membranes around the brain and spinal cord (confirm with trial site)
- You have a history of, or currently have, a lung inflammation condition (not caused by infection) that required steroid treatment
- You currently have an active infection that requires medication to treat it
- You have a known history of HIV infection
- You have a known history of active Hepatitis B or Hepatitis C infection
- You have a known history of active tuberculosis (TB)
- Your doctor believes that any other health condition, treatment, or abnormal test result could affect the study results or make participation not in your best interest
- You have a known psychiatric condition or substance use disorder that might make it difficult to follow the requirements of the trial
- You have previously received a donor tissue or organ transplant
- You have had an allergic reaction to either the IPOL vaccine or the Td (tetanus/diphtheria) vaccine
- You have received a Td vaccine within 30 days before starting immunotherapy treatment
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Georgia Beasley, MD, Duke University
Phone: 919-684-0281
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Number of subjects out of the proposed 25 that successfully receive the vaccine after 4 cycles of IO therapy; Safety, as measured by the change in the number and severity of adverse events deemed related to the vaccine or study procedures (blood draw and biopsies)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.