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Recombinant Interferon Alfa-2b · 1 trial · 5 indications
Will be assessed using a Simon two-stage minimax design.
| Arm | Type | Description |
|---|---|---|
| Treatment (chemokine modulation therapy) | EXPERIMENTAL | Participants undergo pre-treatment biopsy. Participants then undergo chemokine modulation therapy consisting of celecoxib PO BID, recombinant interferon alfa-2b IV over 20 minutes, and rintatolimod IV over 30-60 minutes on days -11 to -9, and -4 to -2. Participants then undergo additional biopsy. Following biopsy and chemokine modulation therapy, participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Biopsy | PROCEDURE | Undergo Biopsy |
| Chemokine Modulation Therapy | PROCEDURE | Undergo chemokine modulation therapy |
| Celecoxib | DRUG | Given by mouth |
| Recombinant Interferon Alfa-2b | BIOLOGICAL | Given intravenously |
| Rintatolimod | DRUG | Given intravenously |
| Pembrolizumab | BIOLOGICAL | Given intravenously |
Inclusion Criteria: * Have pathologically confirmed diagnosis of unresectable or metastatic TNBC with no curative treatment options * Have been informed of other treatment options * Patient has lesion that can be biopsied and is willing to undergo the procedure as part of the protocol * Have an Eas...
Recombinant Interferon Alfa-2b is being studied for use in metastatic triple-negative breast cancer, specifically in patients with estrogen receptor-negative, HER2/neu-negative, and progesterone receptor-negative tumors. It is administered as part of chemokine modulation therapy in combination with pembrolizumab, according to a completed early-phase clinical trial.
Recombinant Interferon Alfa-2b is being developed by AIM ImmunoTech Inc., a biopharmaceutical company traded under the ticker symbol AIM on the stock exchange. The company is investigating this drug in the oncology therapeutic area for the treatment of triple-negative breast cancer.
Recombinant Interferon Alfa-2b is in Phase 1 clinical development for triple-negative breast cancer. The single clinical trial for this indication was an early-phase study that has been completed, and the drug remains investigational and is not yet approved for any use.
Recombinant Interferon Alfa-2b was studied in clinical trial NCT03599453, titled 'Chemokine Modulation Therapy and Pembrolizumab in Treating Participants With Metastatic Triple-Negative Breast Cancer.' This early-phase, uncontrolled trial enrolled 8 female participants in the United States and has been completed.
Recombinant Interferon Alfa-2b is a recombinant form of interferon alfa-2b, a type of cytokine used in cancer therapy. In the context of the clinical trial NCT03599453, it is administered as part of a chemokine modulation regimen combined with pembrolizumab for metastatic triple-negative breast cancer.