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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03688152 | A Safety and Tolerability Study of INCB053914 in Combination With INCB050465 in Diffuse Large B-Cell Lymphoma | PHASE1 | COMPLETED | 9 | — | — | Dec 3, 2018 | Sep 1, 2020 | Nov 10, 2020 | 3 | United States |
TEAE is defined as an adverse event reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
| Arm | Type | Description |
|---|---|---|
| INCB053914 + INCB050465 | EXPERIMENTAL | INCB053914 in combination with INCB050465. |
| Name | Type | Description |
|---|---|---|
| INCB053914 | DRUG | Dose Escalation: INCB053914 at the protocol-defined starting dose in combination with INCB050465, with dose modifications based on tolerability criteria. Dose Expansion: Recommended dose from the dose-escalation study. |
| INCB050465 | DRUG | Dose Escalation: INCB050465 at the protocol-defined starting dose in combination with INCB053914, with dose modifications based on tolerability criteria. Dose Expansion: Recommended dose from the dose-escalation study. |
Inclusion Criteria: * Relapsed or refractory DLBCL, which has been histologically documented, defined as having received at least 2 but no more than 5 prior systemic treatment regimens (eg, an anti-CD20 antibody, an anti-CD20 antibody with or without chemotherapy, or chemotherapy alone) and ineligi...