Td or Polio Vaccine with Checkpoint Therapy for Melanoma

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

Recruiting Phase 1 Interventional Study
Melanoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
25 (estimated)
Sponsor
Duke University · Other
Who this trial is looking for

This trial is looking for adults with advanced melanoma who are receiving specific cancer treatments. Participants will receive a vaccine during their treatment and will provide blood and tissue samples for research.

Are You a Good Fit for This Trial?
Must be taking PD-1 therapyPD-1 plus anti CTLA-4 therapy
Rules you out History of solid organ transplantAllergic reaction to Td or IPOL vaccineReceived Td vaccine within 30 days prior to starting therapy

You may be able to join if

  • I have advanced metastatic melanoma
  • I am at least 18 years old
  • I am scheduled to receive PD-1 therapy or PD-1 plus anti CTLA-4 therapy
  • I can provide written consent for the trial
  • I have at least one lesion that is at least 8 mm in size
  • I have adequate organ function as confirmed by lab tests

You may not be able to join if

  • I have uveal or mucosal melanoma
  • I am pregnant or breastfeeding
  • I have received prior systemic therapy for metastatic melanoma
  • I have an immunodeficiency or take chronic steroids over 10 mg daily
  • I have symptomatic CNS metastases or carcinomatous meningitis
  • I have a history of non-infectious pneumonitis requiring steroids
  • I have an active infection that requires systemic therapy
  • I have a known history of HIV, active hepatitis B, hepatitis C, or active TB

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 sta…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Histologically confirmed advanced metastatic melanoma 2. Male or female participants who are at least 18 years of age on the day of signing informed consent 3. Participants must be planned or scheduled by their treating physician to receive PD-1 therapy or PD-1 plus anti CTLA…
Contacts

Carol Ann Wiggs, BSN

919-684-0281

carolann.wiggs@duke.edu

CONTACT