# Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

> **NCT04390763** · PHASE2 · TERMINATED · sponsor: **Novartis Pharmaceuticals** · enrollment: 164 (actual)

## Conditions studied

- Metastatic Pancreatic Ductal Adenocarcinoma

## Interventions

- **BIOLOGICAL:** NIS793
- **BIOLOGICAL:** Spartalizumab
- **DRUG:** gemcitabine
- **DRUG:** nab-paclitaxel

## Key facts

- **NCT ID:** NCT04390763
- **Lead sponsor:** Novartis Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2020-10-16
- **Primary completion:** 2024-04-26
- **Final completion:** 2024-05-02
- **Target enrollment:** 164 (ACTUAL)
- **Why 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.
- **Last updated:** 2025-10-16


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04390763

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04390763, "Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT04390763. Licensed CC0.

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