MelanomaPhase 1TdVaxNCT05077137
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
A Phase 1 study testing Tetanus Diptheria Vaccine and Polio Boost Immunization in people with Melanoma, run by Duke University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Tetanus Diptheria Vaccine and Polio Boost Immunization
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2021to 1 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- ANC >/= 1500/uL
- platelets >/=100,000/uL
- Hemoglobin >/= 9.0 g/dL
Who cannot join
- 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
- Patients with asymptomatic, stable CNS metastases are allowed provided that they are not on >10mg prednisone daily
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Carol Ann Wiggs, BSN, 919-684-0281, carolann.wiggs@duke.edu
About this study
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
- Melanoma
- Being tested
- Tetanus Diptheria Vaccine, Polio Boost Immunization
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetanus Diptheria VaccineBiological
Also called Tenivac
tetanus and diphtheria toxoids
Polio Boost ImmunizationBiological
Also called IPOL
trivalent inactivated polio vaccine
| Study group | Role | What they receive |
|---|---|---|
| Td Vaccine | Experimental | The first 15 subjects enrolled will receive the Td (tetanus diphtheria) vaccine at cycle 4 of IO therapy. The Td vaccine is administered as 0.5 mL intramuscular injection in the extremity (thigh or upper arm) in closest proximity to the largest tumor. Receives: Biological: Tetanus Diptheria Vaccine |
| IPOL Vaccine | Experimental | Subjects 16 through 25 will receive the IPOL (polio booster) vaccine at cycle 4 of IO therapy. The IPOL vaccine is administered as 0.5 mL intramuscular or subcutaneous injection in the extremity (thigh or upper arm) in closest proximity to the largest tumor Receives: Biological: Polio Boost Immunization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects out of the proposed 25 that successfully receive the vaccine after 4 cycles of IO therapy
Evaluable patients are defined as those who receive four cycles of IO therapy and then receive a Td or IPOL vaccine
Measured: informed consent through date of vaccine (est apx 4-5 months)
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)
Adverse events will only include those that are determined to be related to the study vaccine or study procedures (blood draw and biopsies)
Measured: 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)
Secondary outcomes (1)
Preliminary efficacy, as measured by objective response rate
Number of patients that experience tumor response vs. stable disease vs. progression as determined by PI assessment of standard of care scans
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start7 Sep 2021
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georgia Beasley, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077137
- Sponsor's protocol ID
- Pro00108367
- Acronym
- TdVax
- Status last verified
- Jun 2026
- First submitted
- 13 Sep 2021
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will only be used internally by the study team
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
- ClinicalTrials.gov ID
- NCT05077137
- Acronym / sponsor ID
- TdVax / Pro00108367
- Conditions
- Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Td Vaccine | Experimental | Biological: Tetanus Diptheria VaccineThe first 15 subjects enrolled will receive the Td (tetanus diphtheria) vaccine at cycle 4 of IO therapy. The Td vaccine is administered as 0.5 mL intramuscular injection in the extremity (thigh or upper arm) in closest proximity to the largest tumor. |
| IPOL Vaccine | Experimental | Biological: Polio Boost ImmunizationSubjects 16 through 25 will receive the IPOL (polio booster) vaccine at cycle 4 of IO therapy. The IPOL vaccine is administered as 0.5 mL intramuscular or subcutaneous injection in the extremity (thigh or upper arm) in closest proximity to the largest tumor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tetanus Diptheria VaccineAlso: Tenivactetanus and diphtheria toxoids | Biological | Td Vaccine |
| Polio Boost ImmunizationAlso: IPOLtrivalent inactivated polio vaccine | Biological | IPOL Vaccine |
Primary outcome
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)
1 secondary outcome
Preliminary efficacy, as measured by objective response rate
Time frame: up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No. IPD will only be used internally by the study team
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Georgia Beasley, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tetanus Diptheria Vaccine and Polio Boost Immunization in people with Melanoma, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carol Ann Wiggs, BSN (919-684-0281, carolann.wiggs@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026; AzTrials last refreshed its copy on 1 Nov 2026.