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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of giving the Tetanus Diphtheria Vaccine (Td) or Polio Boost Immunization (IPOL) to patients with advanced metastatic melanoma who are receiving immune checkpoint inhibitor therapy as part of their standard treatment. This study aims to understand how these vaccines may affect the immune response in melanoma patients undergoing this therapy. The research is conducted as a Phase 1 clinical trial sponsored by Duke University. Participants receive either the Td vaccine or the IPOL vaccine at the fourth cycle of their immune checkpoint inhibitor therapy. The first 15 participants receive the Td vaccine as a 0.5 mL intramuscular injection near the largest tumor in the thigh or upper arm. The next 10 participants receive the IPOL vaccine as a 0.5 mL intramuscular or subcutaneous injection in the same way. The study schedules blood and tissue sample collection before starting immune therapy, at cycle 4 before vaccination, and 12 to 17 days after vaccination. Participants will be closely monitored for safety by tracking any adverse events related to the vaccine or study procedures such as blood draws and biopsies. Researchers will measure how many participants successfully receive the vaccine after 4 cycles of therapy and assess preliminary signs of treatment response for up to 36 months. The total study duration includes follow-up visits and scans to evaluate safety and treatment effects after vaccination.
CONDITIONS
Brief 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
- 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 with ANC ≥ 1500/uL, platelets ≥ 100,000/uL, and hemoglobin ≥ 9.0 g/dL based on 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 use of systemic steroids over 10 mg prednisone daily or other immunosuppressive therapy within 7 days before first biopsy
- Symptomatic CNS metastases or carcinomatous meningitis
- History of or active pneumonitis requiring steroids
- Active infection needing systemic therapy
- Known HIV infection
- Known active Hepatitis B or Hepatitis C infection
- Known active tuberculosis
- Any condition, therapy, or lab abnormality that may interfere with study participation or results
- Psychiatric or substance abuse disorders affecting trial cooperation
- History of allogenic tissue or solid organ transplant
- Allergy to IPOL or Td vaccine
- Receipt of Td vaccine within 30 days before starting immune therapy
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 4 to 5 months
Participants receive standard of care immune checkpoint therapy for approximately 4 cycles, followed by a single injection of either the Td (tetanus diphtheria) vaccine or the IPOL (polio booster) vaccine near the largest tumor site.
Visits at baseline, cycle 4 of immune therapy, 12 to 17 days post vaccine, and standard of care scan 8 to 12 weeks post vaccine
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
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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