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

NCT05077137 | Recruiting Phase 1 FDA Drug

• 1 other identifier: Pro00108367
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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

  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)

  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

  up to 36 months

Study Arms (2)

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.

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

Biological: Polio Boost Immunization

Interventions

Tetanus Diptheria Vaccine BIOLOGICAL

tetanus and diphtheria toxoids

Also known as: Tenivac

Td Vaccine

Polio Boost Immunization BIOLOGICAL

trivalent inactivated polio vaccine

Also known as: IPOL

IPOL Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

Diphtheria-Tetanus Vaccine

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Diphtheria Toxoid; Toxoids; Tetanus Toxoid; Vaccines, Combined

Study Officials

• Georgia Beasley, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carol Ann Wiggs, BSN

CONTACT

919-684-0281; carolann.wiggs@duke.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: October 14, 2021
• Study Start: September 7, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)