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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04445844 | INCMGA00012 and Pelareorep for the Treatment of Metastatic Triple Negative Breast Cancer, IRENE Study | PHASE2 | ACTIVE NOT_RECRUITING | 25 | — | — | Jul 13, 2020 | Jun 30, 2025 | Apr 4, 2025 | 2 | United States |
Defined as the percentage of participants having an objective response (complete response \[CR\] or partial response \[PR\]), according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The ORR of the drug will be assessed according to Simon's two stage design. The estimated ORR will be compared to the response rate specified in the null hypothesis (6%) using one-sided exact binomial test at type I error 5%. 95% confidence interval (C.I.) will be also reported.
Will be determined by the number, frequency, duration, and severity of adverse events (AEs) using Common Terminology Criteria for Adverse Events (CTCAE) v 5.0; laboratory tests and vital signs.
| Arm | Type | Description |
|---|---|---|
| Treatment (pelareorep, retifanlimab) | EXPERIMENTAL | Patients receive pelareorep IV over 60 minutes on days 1, 2, 15, and 16. Patients also receive INCMGA00012 IV over 60 minutes on day 3. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Pelareorep | BIOLOGICAL | Given IV |
| Quality-of-Life Assessment | OTHER | Ancillary studies |
| Questionnaire Administration | OTHER | Ancillary studies |
| Retifanlimab | BIOLOGICAL | Given IV |
Inclusion Criteria: * Metastatic or inoperable locally advanced, histologically documented triple negative breast cancer (TNBC) (negative expression of estrogen receptor \[ER\], progesterone receptor \[PR\] and human epidermal growth factor receptor 2 \[HER2\] immunohistochemistry \[IHC\] 0 or 1+, ...