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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02118285 | Intraperitoneal Natural Killer Cells and INCB024360 for Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer | PHASE1 | COMPLETED | 2 | — | — | Jul 28, 2014 | Nov 12, 2015 | Dec 5, 2017 | 1 | United States |
To determine the maximum tolerated dose (MTD) of INCB024360 when administered with intraperitoneal haploidentical donor NK cells/IL-2 after a nonmyeloablative cyclophosphamide/fludarabine (Cy/Flu) preparative regimen in patients with recurrent ovarian, fallopian tube, and primary peritoneal cancer
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | Haploidentical donor NK cells and IL-2 are infused intraperitoneally (IP) after a non-myeloablative preparative regimen of cyclophosphamide and fludarabine. INCB024360, at the assigned dose, begins 2 days before the NK cell infusion and continues twice daily for 90 days. |
| Name | Type | Description |
|---|---|---|
| Fludarabine | DRUG | Fludarabine 25 mg/m\^2 IV on days -6 through -2 from NK cell infusion |
| Cyclophosphamide | DRUG | Cyclophosphamide 30 mg/kg IV on days -5 and -4 from NK cell infusion |
| NK cells | BIOLOGICAL | CD3-/CD19- selected NK cells administered by intraperitoneal (IP) infusion on day 0 |
| IL-2 | BIOLOGICAL | IL-2 at 6 million units/dose IP 3 times a week x 6 doses with the 1st dose given immediately after the NK cell infusion |
| INCB024360 | DRUG | INCB024360 at assigned dose by mouth twice a day begin day -2 and continue for 90 days (+/- 3 days) |
Inclusion Criteria: * Diagnosis of recurrent epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer that has failed or progressed after at least 1 prior salvage chemotherapy regimen directed at recurrent/metastatic disease. * Measurable disease per disease specific RECIST version 1...