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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05465954 | Efineptakin Alfa and Pembrolizumab for the Treatment of Recurrent Glioblastoma | PHASE2 | RECRUITING | 54 | — | — | Jan 24, 2023 | Oct 15, 2028 | Jan 12, 2026 | 1 | United States |
9-month overall survival rate (OS9) rate is defined as the number of "successes" (patients who are alive at least 9 months after beginning study therapy) divided by the total evaluable patients. All patients who have signed a consent form, are eligible, and have begun treatment in Cycle 1 (first cycle of neo-adjuvant pembrolizumab + efineptakin alfa \[NT-I7\]) will be considered evaluable for the primary endpoint.
| Arm | Type | Description |
|---|---|---|
| Treatment (efineptakin alfa, pembrolizumab) | EXPERIMENTAL | BEFORE SURGERY: Patients receive pembrolizumab IV over 30 minutes and efineptakin alfa IM on day 1. Patients then undergo surgery 1 week later. AFTER SURGERY: Patients receive pembrolizumab IV over 30 minutes and efineptakin alfa IM on day 1 of each cycle. Cycles repeat every 42 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo MRI or CT at baseline and on study. Patients also undergo tumor biopsy at baseline and blood sample collection on study. |
| Name | Type | Description |
|---|---|---|
| Biospecimen Collection | PROCEDURE | Correlative studies |
| Efineptakin alfa | BIOLOGICAL | Given IM |
| Pembrolizumab | BIOLOGICAL | Given IV |
| Biopsy | PROCEDURE | Undergo tumor biopsy |
Inclusion Criteria: * Age \>= 18 years * Disease characteristics: * Tissue-confirmed progressive or recurrent World Health Organization (WHO) Grade IV IDH wildtype glioblastoma (including molecular glioblastoma and gliosarcoma) * Previously treated with maximum feasible resection or biopsy, ra...