Could a common vaccine supercharge immunotherapy against melanoma?
NCT ID NCT05077137
First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time
Summary
This study tests whether giving a tetanus-diphtheria or polio vaccine during standard immunotherapy can help the immune system better attack melanoma tumors. About 25 adults with advanced melanoma will receive one of these vaccines after four cycles of checkpoint inhibitor therapy. Researchers will check safety and look for signs of improved tumor response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tetanus-diphtheria vaccine or polio vaccine
- What this could lead to
- If it works, this approach could make existing immunotherapy more effective for people with advanced melanoma, potentially improving tumor shrinkage.
- What could go wrong
- This is a small, early-phase feasibility study with only 25 participants. It may not show a clear benefit, and there is a risk of vaccine-related side effects or no improvement in response.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2021
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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-4 therapy as standard of care 4. Participant (or legally acceptable representative if applicable) provides written informed consent for the trial 5. 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 6. 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 1. ANC \>/= 1500/uL 2. platelets \>/=100,000/uL 3. Hemoglobin \>/= 9.0 g/dL Exclusion Criteria: 1. Uveal or mucosal melanoma 2. Any women known to be pregnant or breastfeeding 3. Any prior systemic therapy for metastatic melanoma (prior surgery is allowed) 4. 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 5. 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 6. History of or active (non-infectious) pneumonitis that required steroids 7. Active infection requiring systemic therapy 8. Known history of Human Immunodeficiency Virus (HIV) infection 9. 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 10. Known history of active TB (Bacillus Tuberculosis) 11. 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 12. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial 13. History of allogenic tissue or solid organ transplant 14. History of allergic reaction to IPOL or Td vaccine 15. Receipt of Td vaccine within 30 days prior to starting IO therapy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Duke University Medical Center
RECRUITINGDurham, North Carolina, 27710, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new antibody help the immune system fight Hard-to-Treat tumors?
- Can tumor DNA and immune cells reveal why some cancers resist immunotherapy?
- A quest to find biomarkers that match melanoma patients with the right immunotherapy
- Can a Two-Drug immune combo shrink melanoma tumors?
- Can teaching patients about immunotherapy cut severe side effects?
- Can a triple immunotherapy attack beat advanced melanoma?