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A Randomized, Double-blind, Phase III Study, Comparing NIS793 in Combination With Gemcitabine and Nab-paclitaxel Versus (vs.) Placebo Combined With Gemcitabine and Nab-paclitaxel for First Line Treatment of Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

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Trial Profile

A Randomized, Double-blind, Phase III Study, Comparing NIS793 in Combination With Gemcitabine and Nab-paclitaxel Versus (vs.) Placebo Combined With Gemcitabine and Nab-paclitaxel for First Line Treatment of Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Jun 2026

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At a glance

  • Drugs Gemcitabine (Primary) ; Nisevokitug (Primary) ; Paclitaxel (Primary)
  • Indications Adenocarcinoma; Pancreatic ductal carcinoma
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms daNIS-2
  • Sponsors Novartis; Novartis Pharmaceuticals

Most Recent Events

  • 19 May 2026 Primary endpoint details were refined to provide clearer outcome definitions and analysis methodology. Additionally, the overall survival endpoint follow-up duration was extended from approximately 19 months to approximately 34 months, enabling longer-term survival assessment.
  • 19 Sep 2024 Status changed from active, no longer recruiting to completed.
  • 29 Aug 2024 This trial has been completed in Belgium, according to European Clinical Trials Database record

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