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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT05077137
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tetanus Diptheria Vaccine — BIOLOGICAL
    tetanus and diphtheria toxoids
  • Polio Boost Immunization — BIOLOGICAL
    trivalent inactivated polio vaccine

Study Details

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.

Key Dates

Start date
Sep 7, 2021
Status verified
Aug 2025
Primary completion
Sep 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710
Carol Ann Wiggs, BSN
[email protected]
919-684-0281

Find similar trials in Durham, NC

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Duke University Medical Center· Durham, NC

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