A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
The purpose of this study is to determine the safety and feasibility of administering the Tetanus Diptheria Vaccine (Td) or Polio Boost Immunization (IPOL) to patients with metastatic melanoma who are receiving immune checkpoint inhibitor (IO) therapy per standard of care. Subjects will have the vaccine at cycle 4 of IO therapy and will have research blood and tissue samples collected prior to starting IO therapy, at cycle 4 prior to vaccine administration, and at 12-17 days post vaccine.
• Histologically confirmed advanced metastatic melanoma
• Male or female participants who are at least 18 years of age on the day of signing informed consent
• Participants must be planned or scheduled by their treating physician to receive PD-1 therapy or PD-1 plus anti CTLA-4 therapy as standard of care
• Participant (or legally acceptable representative if applicable) provides written informed consent for the trial
• Participant must have at least 1 lesion that is at least 8 mm in size and is cutaneous, subcutaneous, palpable, or amenable to ultrasound guided core biopsy. The lesion chosen for biopsy can also be a target lesion but does not have to be a target lesion
• Adequate organ function as defined below. Standard of care labs drawn within 45 days prior to consent may be used for the purposes of determining eligibility
‣ ANC \>/= 1500/uL
⁃ platelets \>/=100,000/uL
⁃ Hemoglobin \>/= 9.0 g/dL