Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2

PHASE3CompletedINTERVENTIONAL
Enrollment

511

Participants

Timeline

Start Date

September 30, 2021

Primary Completion Date

August 13, 2024

Study Completion Date

August 13, 2024

Conditions
Metastatic Pancreatic Ductal Adenocarcinoma
Interventions
DRUG

NIS793

Concentrate for solution infusion (Liquid in Vial)

DRUG

Nab-paclitaxel

Per locally approved formulation

DRUG

Gemcitabine

Per locally approved formulation

DRUG

Placebo

Dextrose 5% in water (D5W) solution for infusion

Trial Locations (113)

1200

Novartis Investigative Site, Brussels

1478

Novartis Investigative Site, Nordbyhagen

2650

Novartis Investigative Site, Edegem

2820

Novartis Investigative Site, Bonheiden

3000

Novartis Investigative Site, Leuven

4032

Novartis Investigative Site, Debrecen

5000

Novartis Investigative Site, Adelaide

6009

Novartis Investigative Site, Perth

6500

Novartis Investigative Site, Bellinzona

9007

Novartis Investigative Site, Sankt Gallen

10002

Novartis Investigative Site, Taipei

10016

NYU Clinical Cancer Center, New York

11217

Novartis Investigative Site, Taipei

13273

Novartis Investigative Site, Marseille

13353

Novartis Investigative Site, Berlin

15706

Novartis Investigative Site, Santiago de Compostela

20133

Novartis Investigative Site, Milan

20162

Novartis Investigative Site, Milan

20249

Novartis Investigative Site, Hamburg

25030

Novartis Investigative Site, Besançon

28009

Novartis Investigative Site, Madrid

28034

Novartis Investigative Site, Madrid

28040

Novartis Investigative Site, Madrid

32804

Advent Health Cancer Institute, Orlando

33305

Novartis Investigative Site, Taoyuan District

34295

Novartis Investigative Site, Montpellier

34722

Novartis Investigative Site, Istanbul

35100

Novartis Investigative Site, Izmir

37126

Novartis Investigative Site, Verona

44093

Novartis Investigative Site, Nantes

44791

Novartis Investigative Site, Bochum

45147

Novartis Investigative Site, Essen

46815

Fort Wayne Medical Oncology Hematology Inc, Fort Wayne

50134

Novartis Investigative Site, Florence

52621

Novartis Investigative Site, Ramat Gan

57001

Novartis Investigative Site, Thessaloniki

60488

Novartis Investigative Site, Frankfurt

69373

Novartis Investigative Site, Lyon 08

72703

Highlands Oncology Group, Fayetteville

74101

Novartis Investigative Site, Nový Jičín

75015

Novartis Investigative Site, Paris

75204

US Oncology Research Dallas, Dallas

77030

Houston Methodist Hospital, Houston

83310

Novartis Investigative Site, Bratislava

84082

Novartis Investigative Site, Avignon

84112

Huntsman Cancer Institute, Salt Lake City

89081

Novartis Investigative Site, Ulm

90095

University of California LA, Los Angeles

94010

Novartis Investigative Site, Créteil

98109

Seattle Cancer Care Alliance, Seattle

100021

Novartis Investigative Site, Beijing

100036

Novartis Investigative Site, Beijing

100730

Novartis Investigative Site, Beijing

116001

Novartis Investigative Site, Dalian

150081

Novartis Investigative Site, Harbin

168583

Novartis Investigative Site, Singapore

196603

Novartis Investigative Site, Pushkin Saint Petersburg

200025

Novartis Investigative Site, Shanghai

200032

Novartis Investigative Site, Shanghai

200127

Novartis Investigative Site, Shanghai

200433

Novartis Investigative Site, Shanghai

210029

Novartis Investigative Site, Nanjing

272000

Novartis Investigative Site, Jining

300480

Novartis Investigative Site, Tianjin

310022

Novartis Investigative Site, Hangzhou

510000

Novartis Investigative Site, Guangzhou

610041

Novartis Investigative Site, Chengdu

644013

Novartis Investigative Site, Omsk

710061

Novartis Investigative Site, Xian

6423906

Novartis Investigative Site, Tel Aviv

9112001

Novartis Investigative Site, Jerusalem

70200-730

Novartis Investigative Site, Brasília

98700-000

Novartis Investigative Site, Ijuí

90035-001

Novartis Investigative Site, Porto Alegre

04014-002

Novartis Investigative Site, São Paulo

L6R 3J7

Novartis Investigative Site, Brampton

N1R 3G2

Novartis Investigative Site, Cambridge

M4N 3M5

Novartis Investigative Site, Toronto

656 53

Novartis Investigative Site, Brno

500 05

Novartis Investigative Site, Hradec Králové

140 59

Novartis Investigative Site, Prague

00290

Novartis Investigative Site, Helsinki

FIN-33521

Novartis Investigative Site, Tampere

06189

Novartis Investigative Site, Nice

06120

Novartis Investigative Site, Halle S

540 07

Novartis Investigative Site, Thessaloniki

H 1122

Novartis Investigative Site, Budapest

H-1097

Novartis Investigative Site, Budapest

464 8681

Novartis Investigative Site, Nagoya

277 8577

Novartis Investigative Site, Kashiwa

241-8515

Novartis Investigative Site, Yokohama

541-8567

Novartis Investigative Site, Osaka

104 0045

Novartis Investigative Site, Chuo Ku

135 8550

Novartis Investigative Site, Koto Ku

3543 AZ

Novartis Investigative Site, Utrecht

NO-0407

Novartis Investigative Site, Oslo

975 17

Novartis Investigative Site, Banská Bystrica

041 91

Novartis Investigative Site, Košice

06591

Novartis Investigative Site, Seoul

03080

Novartis Investigative Site, Seoul

05505

Novartis Investigative Site, Seoul

08035

Novartis Investigative Site, Barcelona

08907

Novartis Investigative Site, L'Hospitalet de Llobregat

SE-205 02

Novartis Investigative Site, Malmo

901 85

Novartis Investigative Site, Umeå

CH 1211

Novartis Investigative Site, Geneva

01250

Novartis Investigative Site, Adana

06230

Novartis Investigative Site, Ankara

SM2 5PT

Novartis Investigative Site, Sutton

CB2 0QQ

Novartis Investigative Site, Cambridge

CH63 4JY

Novartis Investigative Site, Liverpool

EC1A 7BE

Novartis Investigative Site, London

OX3 7LE

Novartis Investigative Site, Oxford

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY