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

Phase 2 Terminated 164 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupOpen-labelTreatment

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

Publications

Pelletier M, Yang J, Joshi M, Grauel A, Abecunas C, Altzerinakou MA, Zhou Z, Zhu X, Clark K, Li L, Bai LY, Milella M, Mercade TM, Tai WMD, Bockorny B, Grell P, Sivakumar S, Wong MK, Chee CE, Aparicio T, Prager G, Bostel G, Schiessl B, Maacke H, Dranoff G, Shaw A, Fabre C, Mataraza J, Malek S, Cremasco V. Biomarker analysis from patients with metastatic PDAC treated with TGFbeta antibody, NIS793, plus abraxane+gemcitabine vs. abraxane+gemcitabine alone in a phase II, open label, randomized study. Clin Cancer Res. 2026 Jun 25. doi: 10.1158/1078-0432.CCR-26-0805. Online ahead of print.

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	Paclitaxel	Small molecule	125 mg/m2	Intravenous

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

Timeline

Publications

Drugs

Indications