A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy

A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy (NCT05077137) is a Phase 1 interventional studying Melanoma, sponsored by Duke University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Melanoma, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 25 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. diagnosed by tissue sample (biopsy-confirmed) advanced metastatic melanoma 2. Male or female participants who are at least 18 years of age on the day of signing willing to sign a consent form 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 willing to sign a consent form 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. your organs (liver, kidneys, etc.) are working well enough based on blood tests 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 Who Should NOT Join This Trial: 1. Uveal or mucosal melanoma 2. Any women known to be pregnant or breastfeeding 3. Any previous cancer treatment that works throughout the body (like chemotherapy) for metastatic melanoma (prior surgery is allowed) 4. Known diagnosis of weakened immune system 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 cancer that has spread to the brain and/or carcinomatous meningitis a) Patients with asymptomatic, stable cancer that has spread to the brain 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 weakened immune system Virus (HIV) infection ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

BIOLOGICAL

Tetanus Diptheria Vaccine

tetanus and diphtheria toxoids

BIOLOGICAL

Polio Boost Immunization

trivalent inactivated polio vaccine

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Duke University Medical Center

Durham, North Carolina, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05077137), the sponsor (Duke University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05077137 clinical trial studying?

Who can participate in NCT05077137?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05077137?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05077137. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05077137. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.