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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03501381 | High Dose IL 2 and Entinostat in RCC | PHASE2 | ACTIVE NOT_RECRUITING | 46 | — | — | May 24, 2018 | Apr 1, 2024 | Sep 1, 2023 | 5 | United States |
Compare PFS between arms. PFS is defined as the time from date of randomization until the criteria for disease progression is met as defined by RECIST 1.1 or death as a result of any cause.
| Arm | Type | Description |
|---|---|---|
| High Dose Interleukin 2 | ACTIVE_COMPARATOR | HD IL-2 600,000 IU/kg Every 8 hours on Days 1-5 and Days 15-19 |
| High Dose Interleukin 2 plus Entinostat | EXPERIMENTAL | HD IL-2 600,000 IU/kg Every 8 hours on Days 1-5 and Days 15-19 plus Entinostat 5 mg orally every 2 weeks starting Day -14 |
| Name | Type | Description |
|---|---|---|
| Entinostat | DRUG | Entinostat should be taken 1-2 hours prior to the HD IL-2 infusion. Dose reductions for entinostat should be followed. Entinostat will continue after high dose IL-2 every 2 weeks |
| Interleukin-2 | DRUG | In the event of clinical benefit after a course of HD IL-2 (stable disease or tumor shrinkage) patients will receive a second treatment course of HD IL-2 therapy. Patients with evidence of tumor shrinkage after the 2nd HD IL-2 treatment course may receive a 3rd treatment course of HD IL-2. |
Inclusion Criteria: * Age ≥ 18 years at the time of consent. * ECOG Performance Status of 0 within 14 days prior to registration. * Life expectancy of greater than 6 months. * Patients must have pathological diagnosis of renal cell carcinoma that is metastatic or surgically unresectable. The histol...