Tetanus Diptheria Vaccine for Melanoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
MelanomaTetanus Diptheria Vaccine - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

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

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: Biological
Td Vaccine
Biological
Experimental Group · 1 Intervention: Tetanus Diptheria Vaccine · Intervention Types: Biological

Trial 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.