Actively Recruiting
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Led by Duke University · Updated on 2025-08-27
25
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed advanced metastatic melanoma
- Male or female participants aged 18 years or older at consent
- Planned or scheduled to receive PD-1 therapy or PD-1 plus anti CTLA-4 therapy as standard of care
- Written informed consent provided by participant or legally acceptable representative
- At least one lesion 8 mm or larger that is cutaneous, subcutaneous, palpable, or suitable for ultrasound-guided core biopsy
- Adequate organ function defined as ANC ≥ 1500/uL, platelets ≥ 100,000/uL, and hemoglobin ≥ 9.0 g/dL using standard labs within 45 days prior to consent
You will not qualify if you...
- Uveal or mucosal melanoma
- Known pregnancy or breastfeeding
- Prior systemic therapy for metastatic melanoma (prior surgery allowed)
- Known immunodeficiency or chronic systemic steroid use exceeding 10 mg prednisone daily or equivalent, or other immunosuppressive therapy within 7 days before first research biopsy
- Symptomatic CNS metastases or carcinomatous meningitis
- History of or active non-infectious pneumonitis requiring steroids
- Active infection requiring systemic therapy
- Known HIV infection
- Known Hepatitis B or active Hepatitis C infection
- Known active tuberculosis
- Any condition, therapy, or lab abnormality that could affect study results or participation
- Psychiatric or substance abuse disorders interfering with study cooperation
- History of allogenic tissue or solid organ transplant
- History of allergic reaction to IPOL or Td vaccine
- Receipt of Td vaccine within 30 days before starting immune therapy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
C
Carol Ann Wiggs, BSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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