NCT05077137 · Duke University
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
(TdVax)
What this study 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 the usual treatment.
View original scientific description
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.
Interventions
BIOLOGICAL
Tetanus Diptheria Vaccine
tetanus and diphtheria toxoids
BIOLOGICAL
Polio Boost Immunization
trivalent inactivated polio vaccine
Primary outcome measures
Number of subjects out of the proposed 25 that successfully receive the vaccine after 4 cycles of IO therapy
Time frame: informed consent through date of vaccine (est apx 4-5 months)
Evaluable patients are defined as those who receive four cycles of IO therapy and then receive a Td or IPOL vaccine
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)
Time frame: Baseline, cycle 4 of IO therapy (apx 12-16 weeks), 12-17 days post vaccine, SOC scan following vaccine (apx 8-12 weeks post vaccine)
Adverse events will only include those that are determined to be related to the study vaccine or study procedures (blood draw and biopsies)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Histologically confirmed advanced metastatic melanoma
- Male or female participants who are at least 18 years of age on the day of signing informed consent
- Participants must be planned or scheduled by their treating physician to receive PD-1 therapy or PD-1 plus anti CTLA-4 therapy as standard of care
- Participant (or legally acceptable representative if applicable) provides written informed consent for the trial
- 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. The lesion chosen for biopsy can also be a target lesion but does not have to be a target lesion
- Adequate organ function as defined below. Standard of care labs drawn within 45 days prior to consent may be used for the purposes of determining eligibility
- ANC \>/= 1500/uL
- platelets \>/=100,000/uL
- Hemoglobin \>/= 9.0 g/dL
Exclusion criteria
- Uveal or mucosal melanoma
- Any women known to be pregnant or breastfeeding
- Any prior systemic therapy for metastatic melanoma (prior surgery is allowed)
- Known diagnosis of immunodeficiency or receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone or equivalent), or any other form of immunosuppressive therapy within 7 days prior to first research biopsy
- Patients with symptomatic CNS metastases and/or carcinomatous meningitis a) Patients with asymptomatic, stable CNS metastases are allowed provided that they are not on \>10mg prednisone daily
- History of or active (non-infectious) pneumonitis that required steroids
- Active infection requiring systemic therapy
- Known history of Human Immunodeficiency Virus (HIV) infection
- Known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection. NOTE: no testing for Hepatitis B or Hepatitis C is required
- Known history of active TB (Bacillus Tuberculosis)
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with subject's participation for the full duration of the study, or make it not in the best interest of the subject to participate, in the opinion of the treating physician
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
- History of allogenic tissue or solid organ transplant
- History of allergic reaction to IPOL or Td vaccine
- Receipt of Td vaccine within 30 days prior to starting IO therapy
Where
- Durham, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations