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

PHASE2TerminatedINTERVENTIONAL
Enrollment

164

Participants

Timeline

Start Date

October 16, 2020

Primary Completion Date

April 26, 2024

Study Completion Date

May 2, 2024

Conditions
Metastatic Pancreatic Ductal Adenocarcinoma
Interventions
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.

Trial Locations (31)

2145

Novartis Investigative Site, Westmead

3000

Novartis Investigative Site, Melbourne

4000

Novartis Investigative Site, Liège

5020

Novartis Investigative Site, Salzburg

8091

Novartis Investigative Site, Zurich

9007

Novartis Investigative Site, Sankt Gallen

10002

Novartis Investigative Site, Taipei

15232

Univ of Pittsburgh Cancer Institute, Pittsburgh

20089

Novartis Investigative Site, Rozzano

20132

Novartis Investigative Site, Milan

20141

Novartis Investigative Site, Milan

21231

Sidney Kimmel CCC At JH, Baltimore

28050

Novartis Investigative Site, Madrid

30322

Winship Cancer Institute, Atlanta

31054

Novartis Investigative Site, Toulouse

37134

Novartis Investigative Site, Verona

40447

Novartis Investigative Site, Taichung

45147

Novartis Investigative Site, Essen

69120

Novartis Investigative Site, Heidelberg

75475

Novartis Investigative Site, Paris

89081

Novartis Investigative Site, Ulm

119074

Novartis Investigative Site, Singapore

168583

Novartis Investigative Site, Singapore

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Cente, Boston

A-1090

Novartis Investigative Site, Vienna

656 53

Novartis Investigative Site, Brno

FIN-00029

Novartis Investigative Site, Helsinki

08035

Novartis Investigative Site, Barcelona

08036

Novartis Investigative Site, Barcelona

OX3 7LE

Novartis Investigative Site, Oxford

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY