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

Sponsor
Duke University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05077137
Collaborator
(none)
25
1
2
35.8
0.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Tetanus Diptheria Vaccine
  • Biological: Polio Boost Immunization
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Actual Study Start Date :
Sep 7, 2021
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Td Vaccine

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
tetanus and diphtheria toxoids
Other Names:
  • Tenivac
  • Experimental: IPOL Vaccine

    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
    trivalent inactivated polio vaccine
    Other Names:
  • IPOL
  • Outcome Measures

    Primary Outcome Measures

    1. Number of subjects out of the proposed 25 that successfully receive the vaccine after 4 cycles of IO therapy [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

    2. 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) [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)

    Secondary Outcome Measures

    1. Preliminary efficacy, as measured by objective response rate [up to 36 months]

      Number of patients that experience tumor response vs. stable disease vs. progression as determined by PI assessment of standard of care scans

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    7. ANC >/= 1500/uL

    8. platelets >/=100,000/uL

    9. 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

    1. Patients with asymptomatic, stable CNS metastases are allowed provided that they are not on >10mg prednisone daily
    1. History of or active (non-infectious) pneumonitis that required steroids

    2. Active infection requiring systemic therapy

    3. Known history of Human Immunodeficiency Virus (HIV) infection

    4. 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

    5. Known history of active TB (Bacillus Tuberculosis)

    6. 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

    7. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

    8. History of allogenic tissue or solid organ transplant

    9. History of allergic reaction to IPOL or Td vaccine

    10. Receipt of Td vaccine within 30 days prior to starting IO therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Duke University Medical Center Durham North Carolina United States 27710

    Sponsors and Collaborators

    • Duke University

    Investigators

    • Principal Investigator: Georgia Beasley, MD, Duke University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT05077137
    Other Study ID Numbers:
    • Pro00108367
    First Posted:
    Oct 14, 2021
    Last Update Posted:
    Oct 14, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 14, 2021