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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: Recruiting Phase 1 study of Melanoma, sponsored by Duke University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Evaluable patients are defined as those who receive four cycles of IO therapy and then receive a Td or IPOL 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 |
What NCT05077137 shows while recruiting
NCT05077137 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (96% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Melanoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05077137's enrollment target sits among peer trials
25 215th of 266 higher than 49 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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