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)

A Phase II, Open Label, Randomized, Parallel Arm Study of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy Gemcitabine/Nab-paclitaxel, and Gemcitabine/Nab-paclitaxel Alone in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, parallel arms, open-label, multi-center, Phase II study to evaluate the efficacy and safety of NIS793 with and without spartalizumab in combination with gemcitabine/nab-paclitaxel in participants with first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). The study started with a Safety Run-in to assess the safety and tolerability of NIS793 in combination with spartalizumab and standard of care (SOC) gemcitabine/nab-paclitaxel. Doses defined for each study treatment, as part of this quadruplet were administered in the Randomized part in the quadruplet/triplet/doublet-based treatment arms. The Randomized part opened after the Safety Run-in had completed. Participants were randomized in a 1:1:1 ratio to one of the three treatment arms: * Arm 1: NIS793 with spartalizumab and gemcitabine/nab-paclitaxel * Arm 2: NIS793 with gemcitabine/nab-paclitaxel * Arm 3: gemcitabine/nab-paclitaxel

Conditions

• Metastatic Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
BIOLOGICAL	NIS793	anti-TGFb antibody. NIS793 2100 mg every 2 weeks by intravenous (i.v.) infusion.
BIOLOGICAL	Spartalizumab	anti-PD-1 antibody. spartalizumab 400 mg every 4 weeks by i.v. infusion.
DRUG	gemcitabine	SOC chemotherapy. Gemcitabine (1000 mg/m\^2 on Days 1, 8, and 15) i.v. given as per label.
DRUG	nab-paclitaxel	SOC chemotherapy. Nab-paclitaxel (125 mg/m\^2 on Days 1, 8, and 15) i.v. given as per label.

Timeline

• Start date: 2020-10-16
• Primary completion: 2024-04-26
• Completion: 2024-05-02
• First posted: 2020-05-18
• Last updated: 2025-10-16
• Results posted: 2025-05-28

Locations

31 sites across 14 countries: United States, Australia, Austria, Belgium, Czechia, Finland, France, Germany, Italy, Singapore, Spain, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study