Clinical Research Directory
Browse clinical research sites, groups, and studies.
Rintatolimod, Celecoxib and Interferon Alpha 2b With Pembrolizumab For the Treatment of Patients With Metastatic or Unresectable Triple Negative Breast Cancer
Sponsor: Roswell Park Cancer Institute
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.
Official title: Phase I/IIa Clinical Trial Evaluating the Safety and Efficacy of Rintatolimod Combined With IFNα2b (Bioferon®) to Enhance the Effectiveness of Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
5
Start Date
2024-02-16
Completion Date
2025-06-19
Last Updated
2026-08-31
Healthy Volunteers
No
Conditions
Interventions
Biopsy
Undergo tumor biopsy
Biospecimen Collection
Undergo blood sample collection
Celecoxib
Given PO
Computed Tomography
Undergo CT scan
Interferon Alpha-2
Given IV
Magnetic Resonance Imaging
Undergo MRI
Pembrolizumab
Given IV
Rintatolimod
Given IV
Locations (1)
Roswell Park Cancer Institute
Buffalo, New York, United States