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NCT05077137 · ClinicalTrials.gov registry record · Phase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
A Phase 1 study of Melanoma, sponsored by Duke University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT05077137 is a Phase 1 study of Melanoma that is actively recruiting participants, run by Duke University. The registered enrollment target is 25 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05077137, a Phase 1 study of Melanoma, is actively recruiting participants, sponsored by Duke University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- BIOLOGICAL Tetanus Diptheria Vaccine
- BIOLOGICAL Polio Boost Immunization
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2021-09-07 |
| Est. Completion | 2026-09-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05077137
The ClinicalTrials.gov registry entry for NCT05077137 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (96% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Tetanus Diptheria Vaccine is the first listed.
NCT05077137 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT05077137 about?
NCT05077137 is a clinical study titled "A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy". 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 vac...
What is the current status of trial NCT05077137?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2021-09-07. Estimated completion is 2026-09-01.
What conditions does trial NCT05077137 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT05077137?
The interventions under investigation include: Tetanus Diptheria Vaccine (BIOLOGICAL), Polio Boost Immunization (BIOLOGICAL).
Who is sponsoring clinical trial NCT05077137?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05077137 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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