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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 is a Phase 1 study that was terminated before completion, run by Roswell Park Cancer Institute. The registered enrollment target is 5 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05756166
The ClinicalTrials.gov registry entry for NCT05756166 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Roswell Park Cancer Institute, which has 365 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05756166 reports 0 study locations.
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.
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