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NCT04093323 · ClinicalTrials.gov registry record · Phase 2
Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma
A Phase 2 study, sponsored by Roswell Park Cancer Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT04093323: Clinical Trial Phase 2 study, sponsored by Roswell Park Cancer Institute.
NCT04093323 is a Phase 2 study that was terminated before completion, run by Roswell Park Cancer Institute. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04093323, a Phase 2 study, was terminated before completion, sponsored by Roswell Park Cancer Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
This phase II trial studies how well polarized dendritic cell (aDC1) based therapy, interferon alpha-2, rintatolimod, and celecoxib work together in treating patients with HLA-A2 positive (+) melanoma that has not responded to previous treatment (refractory). The aDC1 cell-based treatment contains white blood cells (dendritic cells or DCs) that stimulates the immune system. Interferon alpha-2 can improve the body's natural response to infections and other diseases. It can also interfere with the division of cancer cells and slow tumor growth. Rintalolimid may stimulate the immune system. Celecoxib is a drug that reduces pain. This study is being done to find out if the combination of the study cell-based treatment (aDC1 dendritic cells) and interferon alpha-2, rintatolimod, and celecoxib can prevent the growth and/or progression of melanoma.
Primary Outcome
Will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Will be carried out by an exact binomial test of a proportion within a Simon two-stage design.
Interventions
- DRUG Celecoxib
- BIOLOGICAL Recombinant Interferon Alfa-2b
- BIOLOGICAL Alpha-type-1 Polarized Dendritic Cells
- DRUG PD-1 Ligand Inhibitor
- DRUG PD1 Inhibitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2024-11-13 |
| Est. Completion | 2025-06-19 |
| Phase | Phase 2 |
Why NCT04093323 stopped before completion
NCT04093323 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 5 interventions - of which Celecoxib is the first listed.
NCT04093323 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04093323 about?
NCT04093323 is a clinical study titled "Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma". This phase II trial studies how well polarized dendritic cell (aDC1) based therapy, interferon alpha-2, rintatolimod, and celecoxib work together in treating patients with HLA-A2 positive (+) melanoma that has not responded to previous treatment (refractory). The aDC1 cell-based treatment contains w...
What is the current status of trial NCT04093323?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2024-11-13. Estimated completion is 2025-06-19.
What interventions are being tested in trial NCT04093323?
The interventions under investigation include: Celecoxib (DRUG), Recombinant Interferon Alfa-2b (BIOLOGICAL), Alpha-type-1 Polarized Dendritic Cells (BIOLOGICAL), PD-1 Ligand Inhibitor (DRUG), PD1 Inhibitor (DRUG).
Who is sponsoring clinical trial NCT04093323?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04093323's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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