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TPS4173 : Phase II study of the anti-TGF-β monoclonal antibody (mAb) NIS793 with and without the PD-1 inhibitor spartalizumab in combination with nab-paclitaxel/gemcitabine (NG) versus NG alone in patients (pts) with first-line metastatic pancreatic ductal adenocarcinoma (mPDAC).

Researchers

Presenter

  • Peter Grell

Principal Investigators

  • Chia-Chi Lin

  • Michele Milella

  • Cheng Ean Chee

  • Shivan Sivakumar

  • Katriina Johanna Peltola

  • Geraldine Bostel

  • Dragana Jankovic

  • Maria-Athina Altzerinakou

  • Claire Fabre

  • Armando Santoro

Medical Centers

  • Masaryk Memorial Cancer Institute, Brno, Czech Republic, Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan, Section of Oncology, University of Verona School of Medicine and Verona University Hospital Trust, Verona, Italy

  • National University Singapore Cancer Institute, NA, Singapore

  • Singapore

  • Churchill Hospital, Oxford, United Kingdom

  • Helsinki University Hospital Comprehensive Cancer Center, Helsinki, Finland

  • Novartis Institutes for BioMedical Research, Basel, Switzerland

  • Novartis, Rueil-Malmaison, France

  • Humanitas Clinical and Research Center–IRCCS, Rozzano, Milan and Humanitas University, Department of Biomedical Sciences, Pieve Emanuele Hospital, Milan, Italy

Locations

  • Italy

  • Singapore

  • United Kingdom

  • Finland

  • Switzerland

  • France

Companies

  • N/A

Study Components

Therapeutic Area

  • Oncology (ONC)

Disease

  • Pancreas ductal adenocarcinoma

Biomarkers

  • Programmed cell death protein 1

  • Programmed death-ligand 1

  • Cluster of differentiation 8A

Drug/Treatment

  • PDR001

  • Gemcitabine

  • Paclitaxel

Outcome

  • N/A


Study Design

  • Randomized

  • Pharmacokinetics

  • Open Label

  • Multicenteric

Phase

  • II

Study Id's

  • NCT04390763

Sponsors

  • N/A

Result

  • N/A