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: Phase II study (daNIS-1) 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

  • Li-Yuan Bai

Principal Investigators

  • Peter Grell

  • Cheng Ean Chee

  • Anuradha Krishnamurthy

  • Mark Ka Wong

  • Michael Michael

  • Michele Milella

  • Gerald Prager

  • Christoph Springfeld

  • Joelle Collignon

  • Jens Siveke

  • Armando Santoro

  • Chia-Chi Lin

  • Katriina Johanna Peltola

  • Geraldine Bostel

  • Dragana Jankovic

  • Maria-Athina Altzerinakou

  • Claire Fabre

  • Shivan Sivakumar

Medical Centers

  • Humanitas Research Hospital, Rozzano, Italy

  • Westmead Cancer Care Center, Westmead, Australia

  • Novartis Institutes for BioMedical Research, Basel, Switzerland

  • National University Hospital Singapore, Singapore, Singapore

  • University of Pittsburgh Medical Center, Pittsburgh, PA

  • Heidelberg University Hospital, Heidelberg, Germany

  • Universtitatsklinikum Essen AoR, Essen, Germany

  • Novartis Pharmaceuticals AG, Basel, Switzerland

  • Helsingin yliopistollinen keskussairaala, Helsinki, Finland

  • Department of Oncology, University of Oxford, Oxford, United Kingdom

  • Vall d'Hebron University Hospital, Barcelona, Spain

  • U.O.C. Oncology, University of Verona, Azienda Ospedaliera Universitaria Integrata, Verona, Italy

  • National Taiwan University Hospital, Taipei City, Taiwan

  • Medical Oncology Department-CHU Sart-Tilman, Liège, Belgium

  • Peter Mac Callum, Melbourne, VIC, Australia

  • Masaryk Memorial Cancer Institute, Brno, Czech Republic

  • China Medical University Hospital, Taichung, Taiwan

  • Uni Klinik fuer Innere Medizin I, Vienna, Austria

Locations

  • Singapore

  • United Kingdom

  • Australia

  • United States

  • Czech Republic

  • Finland

  • Belgium

  • Italy

  • Austria

  • Switzerland

  • Taiwan

  • Germany

  • Spain

Companies

  • Novartis AG

Study Components

Therapeutic Area

  • Oncology (ONC)

Disease

  • Pancreas ductal adenocarcinoma

Biomarkers

  • Programmed cell death protein 1

  • Programmed death-ligand 1

  • Cluster of differentiation 8A

  • Transforming growth factor beta

Drug/Treatment

  • PDR001

  • Gemcitabine

  • Paclitaxel

Outcome

  • N/A

Study Design

  • Randomized

  • Pharmacokinetics

  • Open Label

Phase

  • II

Study Id's

  • NCT04390763

Sponsors

  • Novartis

Result

  • N/A

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