Study Summary
This trial will study the safety of giving the Tetanus Diptheria Vaccine or Polio Boost Immunization to patients with metastatic melanoma who are already receiving immune checkpoint inhibitor therapy.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 1 Secondary · Reporting Duration: informed consent through date of vaccine (est apx 4-5 months)
Week 16
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)
Month 5
Number of subjects out of the proposed 25 that successfully receive the vaccine after 4 cycles of IO therapy
up to 36 months
Preliminary efficacy, as measured by objective response rate
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
IPOL Vaccine
1 of 2
Td Vaccine
1 of 2
Experimental Treatment
25 Total Participants · 2 Treatment Groups
Primary Treatment: Tetanus Diptheria Vaccine · No Placebo Group · Phase 1
IPOL Vaccine
Biological
Experimental Group · 1 Intervention: Polio Boost Immunization · Intervention Types: BiologicalTd Vaccine
Biological
Experimental Group · 1 Intervention: Tetanus Diptheria Vaccine · Intervention Types: BiologicalTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: informed consent through date of vaccine (est apx 4-5 months)
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,179 Previous Clinical Trials
3,200,689 Total Patients Enrolled
16 Trials studying Melanoma
426 Patients Enrolled for Melanoma
Georgia Beasley, MDPrincipal InvestigatorDuke University
1 Previous Clinical Trials
12 Total Patients Enrolled
1 Trials studying Melanoma
12 Patients Enrolled for Melanoma
Eligibility Criteria
Age 18+ · All Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have adequate organ function as defined below.
You have a hemoglobin level of >/= 9.0 g/dL.
The 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.
You have provided informed consent for the trial.\n
You are at least 18 years of age.
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Conditions
Cancer Related
Treatments