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NCT05756166 · ClinicalTrials.gov registry record · Phase 1
Rintatolimod, Celecoxib and Interferon Alpha 2b With Pembrolizumab For the Treatment of Patients With Metastatic or Unresectable Triple Negative Breast Cancer
A Phase 1 study, sponsored by Roswell Park Cancer Institute.
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT05756166: Clinical Trial Phase 1 study, sponsored by Roswell Park Cancer Institute.
NCT05756166 is a Phase 1 study that was terminated before completion, run by Roswell Park Cancer Institute. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05756166, a Phase 1 study, was terminated before completion, sponsored by Roswell Park Cancer Institute.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
This phase I/IIa trial tests the safety, side effects, and best dose of chemokine modulation therapy (CKM) (rintatolimod, celecoxib, and interferon alpha 2b) in combination with pembrolizumab for the treatment of patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). CKM drugs such as rintatolimod and interferon alpha 2b work to modify the immune response and tumor-related processes, including tumor cell growth, blood vessel growth, and metastasis. Celecoxib is an anti-inflammatory drug that can cause cell death and may reduce the growth of blood vessels tumors need to grow and spread. Immunotherapy such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving CKM therapy prior to pembrolizumab may direct the immune cells to the cancer cells and maximize the effectiveness of pembrolizumab in patients with metastatic or unresectable triple negative breast cancer.
Primary Outcome
The dose limiting toxicities will be summarized by cohort using frequencies and relative frequencies.
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy
- DRUG Celecoxib
- BIOLOGICAL Interferon Alpha-2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2024-02-16 |
| Est. Completion | 2025-06-19 |
| Phase | Phase 1 |
Why NCT05756166 stopped before completion
NCT05756166 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05756166 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05756166 about?
NCT05756166 is a clinical study titled "Rintatolimod, Celecoxib and Interferon Alpha 2b With Pembrolizumab For the Treatment of Patients With Metastatic or Unresectable Triple Negative Breast Cancer". This phase I/IIa trial tests the safety, side effects, and best dose of chemokine modulation therapy (CKM) (rintatolimod, celecoxib, and interferon alpha 2b) in combination with pembrolizumab for the treatment of patients with triple negative breast cancer that has spread from where it first started...
What is the current status of trial NCT05756166?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2024-02-16. Estimated completion is 2025-06-19.
What interventions are being tested in trial NCT05756166?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Celecoxib (DRUG), Interferon Alpha-2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05756166?
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 NCT05756166's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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