Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mogamulizumab+ Nivolumab · 1 trial · 5 indications
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 |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Mogamulizumab + Nivolumab is an investigational combination of two monoclonal antibodies being studied for the treatment of solid tumors, including hepatocellular carcinoma (HCC). It is intended for patients with locally advanced or metastatic solid tumors. The combination is currently in clinical development and is not yet approved by regulatory authorities.
Mogamulizumab targets CCR4, a chemokine receptor expressed on certain T cells, while Nivolumab targets PD-1, an immune checkpoint protein. By blocking these targets, the combination aims to enhance the immune system's ability to fight cancer cells. This mechanism is being evaluated in the context of solid tumors.
Mogamulizumab + Nivolumab is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials to evaluate the safety and efficacy of this combination therapy in patients with solid tumors.
Mogamulizumab + Nivolumab is in Phase 1 clinical development. It is an investigational combination therapy and has not been approved by the FDA or any other regulatory agency. The Phase 1 trial has been completed, and the results are being analyzed to determine next steps in development.
Mogamulizumab + Nivolumab has one completed clinical trial, identified as NCT02705105. This Phase 1 study enrolled 114 participants with locally advanced or metastatic solid tumors, including hepatocellular carcinoma. The trial was conducted in the United States and included patients aged 18 years and older.
Mogamulizumab + Nivolumab is a combination of two separate drugs: mogamulizumab and nivolumab. It is not the same as either drug used alone. The combination is being studied to determine if the two agents together provide greater benefit than either alone in treating solid tumors.