Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
Summary
The purpose of this Phase II study is to assess the efficacy and safety of NIS793 with and without spartalizumab in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in previously untreated mPDAC.
Timeline
- Start
- 2020-10-16
- Primary completion
- 2024-04-26
- Completion
- 2024-05-02
Outcome
Missed primary endpoint
Stopped: “The study was early terminated following the NIS793 treatment halt and urgent safety measure issued in July 2023, as the continued evaluation of Standard of Care alone will not support the original purpose of this phase 2 clinical trial.”
registry Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel vs Arm 3: Gemcitabine/Nab-paclitaxel; p = 0.46; Hazard Ratio (HR) 1.02 NCT04390763 ↗
registry Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel vs Arm 3: Gemcitabine/Nab-paclitaxel; p = 0.38; Hazard Ratio (HR) 1.08 NCT04390763 ↗
paper clinical efficacy was not observed: median PFS and OS were comparable or numerically worse in NIS793 arm versus control PMID 42347868 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NISEVOKITUG | Monoclonal antibody | 2100 mg | Intravenous |
| Subject | Spartalizumab | Monoclonal antibody | 400 mg | Intravenous |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Background | Nab-paclitaxel | Small molecule | 125 mg/m2 | Intravenous |