Study of Tetanus Diptheria or Polio Booster Vaccines to Improve Immune Checkpoint Therapy Response in Adults with Metastatic Melanoma

What this Trial Is About

Researchers are evaluating the safety and feasibility of giving the Tetanus Diptheria Td vaccine or the Polio Boost Immunization IPOL to patients with advanced metastatic melanoma who are receiving immune checkpoint inhibitor IO therapy as part of their standard care. The study aims to see if these vaccines can be safely administered during the fourth cycle of IO therapy and to understand how the immune system responds. This is a Phase 1 treatment study conducted by Duke University. Participants receive either the Td vaccine or the IPOL vaccine at cycle 4 of their IO therapy. The first 15 subjects will get the Td vaccine as a 0.5 mL injection in the muscle near the largest tumor, either in the thigh or upper arm. Subjects 16 through 25 will receive the IPOL vaccine, also as a 0.5 mL injection given intramuscularly or subcutaneously near the largest tumor. Blood and tissue samples are collected before starting IO therapy, at cycle 4 before vaccination, and again 12 to 17 days after the vaccine. Participants are involved in regular assessments including research blood draws and tissue biopsies to evaluate safety and immune response. The main outcomes measured include the number of subjects who successfully receive the vaccine after 4 cycles of IO therapy and any changes in adverse events related to the vaccine or study procedures. Safety is monitored through scans and lab tests up to 8 to 12 weeks post-vaccine. Preliminary efficacy is also explored over a period of up to 36 months. The overall study duration may last several months from consent through post-vaccine follow-up.

A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy