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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02705105 | Study of Mogamulizumab + Nivolumab in Subjects w/Locally Advanced or Metastatic Solid Tumors | PHASE1 | COMPLETED | 114 | — | — | Feb 1, 2016 | Oct 10, 2018 | Apr 25, 2024 | 15 | United States |
The MTD was defined as one dose level below the dose level of the cohort where ≥ one-third of the subjects experienced a dose-limiting toxicity (DLT)
combination of mogamulizumab and nivolumab
| Arm | Type | Description |
|---|---|---|
| Dose-Finding Cohort | EXPERIMENTAL | Cycle 1 Days 1, 8, 15, and 22: Dose Level 1 of Mogamulizumab + Nivolumab Subsequent Cycles Days 1 and 15: Dose Level 1 of Mogamulizumab + Nivolumab If \>1 patient has a DLT at first dose level, then the following cohort will be enrolled: Cycle 1 Days 1, 8, 15, and 22: Optional Dose Level of Mogamulizumab + Nivolumab Subsequent Cycles Days 1 and 15: Optional Dose Level of Mogamulizumab + Nivolumab |
| Expansion Cohort | EXPERIMENTAL | Cycle 1 Days 1, 8, 15, and 22: Maximum Tolerated Dose of Mogamulizumab + Nivolumab Subsequent Cycles Days 1 and 15: Maximum Tolerated Dose of Mogamulizumab + Nivolumab Subjects will be separated further into cohorts by tumor type |
| Name | Type | Description |
|---|---|---|
| Mogamulizumab + Nivolumab | BIOLOGICAL | i.v. administration |
Inclusion Criteria * Subject is age 18 years or older; * Subject must have histologically or cytologically confirmed solid tumor; * Subject must have locally advanced or metastatic solid tumor; * Subjects who have progressed or have been intolerant to any standard treatment regimen or refused stand...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |