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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02502786 | Humanized Monoclonal Antibody 3F8 (Hu3F8) With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma | PHASE2 | ACTIVE NOT_RECRUITING | 46 | — | — | Jul 1, 2015 | Jul 1, 2026 | Oct 7, 2025 | 3 | United States |
EFS is defined as the time from surgery to relapse or death from any cause, recurrence of tumor or second malignancy.
| Arm | Type | Description |
|---|---|---|
| humanized anti-GD2 antibody, hu3F8, when combined with GM-CSF | EXPERIMENTAL | One cycle consists of treatment with hu3F8 at a dose of 2.4mg/kg/dose for 3 days (day 1, 3, and 5) in the presence of subcutaneous (sc) GM-CSF (day -4 through 5). These 3 doses of hu3F8 and 10 days of GM-CSF constitute a treatment cycle. Cycles are repeated at \~2-4 week intervals between first days of hu3F8, through 5 cycles. A maximum of 5 cycles will be administered on protocol. If elevations of amylase and/or lipase (\>Grade 1) or clinical signs suggestive of pancreatitis (e.g. upper abdominal pain) occurs, naxitamab and GM-CSF doses should be held until improvement of toxicity to ≤Grade 1 if laboratory elevations and/or pancreatitis is possibly related to either naxitamab or GM-CSF. |
| Name | Type | Description |
|---|---|---|
| humanized anti-GD2 antibody | BIOLOGICAL | - |
| GM-CSF | DRUG | - |
Inclusion Criteria: * Patients must have recurrent OS. OS must be verified by histopathology review by the site's Department of Pathology. (Patients registered at MSK must have pathology confirmed by MSK Department of Pathology.) * Patients must be in a ≥2nd complete remission as indicated by appro...