Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03599453 | Chemokine Modulation Therapy and Pembrolizumab in Treating Participants With Metastatic Triple-Negative Breast Cancer | EARLY_PHASE1 | COMPLETED | 8 | — | — | Jan 9, 2019 | Mar 21, 2023 | Jul 18, 2023 | 1 | United States |
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...