Feasibility Study of Tetanus/Polio Vaccines with Immunotherapy for Melanoma
This study is looking at whether giving the Tetanus Diptheria Vaccine (Td) or Polio Boost Immunization (IPOL) is safe and practical for people with advanced melanoma who are already receiving standard immunotherapy (checkpoint inhibitor therapy). Researchers want to see how many of the 25 planned participants can successfully receive the vaccine after about 4 cycles of their regular immunotherapy. They will also track any side effects related to the vaccines or study procedures like blood draws and biopsies. You may be able to join if you are 18 or older, have advanced melanoma, and your doctor plans for you to receive PD-1 therapy or PD-1 plus anti CTLA-4 therapy. The study status is currently unclear.
- Study design
- This is an interventional study planning to enroll 25 participants. It is not specified if it is randomized or blinded.
- What's involved
- You would receive either the Tetanus Diptheria Vaccine or Polio Boost Immunization at cycle 4 of your immunotherapy. Blood and tissue samples will be collected before immunotherapy, at cycle 4 before the vaccine, and 12-17 days after the vaccine.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety will be measured at baseline, cycle 4 of immunotherapy, 12-17 days post-vaccine, and after a standard scan following the vaccine (about 8-12 weeks post-vaccine).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Georgia Beasley, MD · PRINCIPAL_INVESTIGATOR · Duke University
Who to contact
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What this trial measures
- Number of subjects out of the proposed 25 that successfully receive the vaccine after 4 cycles of IO therapyinformed consent through date of vaccine (est apx 4-5 months)
Evaluable patients are defined as those who receive four cycles of IO therapy and then receive a Td or IPOL vaccine
- 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)Baseline, cycle 4 of IO therapy (apx 12-16 weeks), 12-17 days post vaccine, SOC scan following vaccine (apx 8-12 weeks post vaccine)
Adverse events will only include those that are determined to be related to the study vaccine or study procedures (blood draw and biopsies)