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Canakinumab; spartalizumab, nab-paclitaxel, gemcitabine · 1 trial · 1 indication
Evaluate dose limiting toxicities of patients with metastatic pancreatic cancer for at least 56 days (DLT period) after dosing with canakinumab at 250 mg every 4 weeks (Q4W), 400mg Spartalizumab Q4W and Gemcitabine/nab-paclitaxel on Days 1, 8 and 15 at standard of care levels. Dose limiting toxicities were evaluated to determine if dosing of canakinumab at 250 mg every 4 weeks with the other three drugs was considered tolerable and should be the dose utilized for future Phase 2/3 clinical trials. The starting dose level of canakinumab explored was 250 mg every 4 weeks (Q4W) ("starting dose level"). In case of unacceptable toxicity of canakinumab at 250 mg Q4W, the dose of canakinumab was to be de-escalated to 250 mg every 8 weeks, while other components of the combination were kept at the same dose as the starting dose level. Approximately 10 patients were to be enrolled in this study to have at least 6 evaluable patients per dose level of canakinumab.
| Arm | Type | Description |
|---|---|---|
| Canakinumab, spartalizumab, nab-paclitaxel and gemcitabine | EXPERIMENTAL | Spartalizumab (PDR001),IV infusion, 400 mg, D1 of each 28-day cycle; Canakinumab (ACZ885), s.c. injection, 250 mg, Day 1 of each 28- day cycle; Gemcitabine, IV Infusion, 1000 mg/m2, Days 1, 8, 15 of each 28-day cycle; Nab-paclitaxel, IV Infusion, 125 mg/m2, Days 1, 8, 15 of each 28-day cycle. |
| Name | Type | Description |
|---|---|---|
| Canakinumab injection; spartalizumab, nab-paclitaxel, gemcitabine | DRUG | Canakinumab 250 mg s.c. injection; Spartalizumab 400 mg IV infusion, nab-paclitaxel 125 mg/m2 IV infusion, gemcitabine 1000 mg/m2 IV infusion |
Inclusion Criteria: * Age \> 18 years at the time of informed consent * Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC) (determined by a local laboratory) with metastatic spread of disease (adenosquamous is also allowed). * Patients must have not received previous ...