Melanoma Clinical Trial
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Summary
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.
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Uveal or mucosal melanoma
Any women known to be pregnant or breastfeeding
Any prior systemic therapy for metastatic melanoma (prior surgery is allowed)
Known diagnosis of immunodeficiency or receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone or equivalent), or any other form of immunosuppressive therapy within 7 days prior to first research biopsy
Patients with symptomatic CNS metastases and/or carcinomatous meningitis
a) Patients with asymptomatic, stable CNS metastases are allowed provided that they are not on >10mg prednisone daily
History of or active (non-infectious) pneumonitis that required steroids
Active infection requiring systemic therapy
Known history of Human Immunodeficiency Virus (HIV) infection
Known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. NOTE: no testing for Hepatitis B or Hepatitis C is required
Known history of active TB (Bacillus Tuberculosis)
History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with subject's participation for the full duration of the study, or make it not in the best interest of the subject to participate, in the opinion of the treating physician
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
History of allogenic tissue or solid organ transplant
History of allergic reaction to IPOL or Td vaccine
Receipt of Td vaccine within 30 days prior to starting IO therapy
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