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
- Trial number:
- NCT04935359
- Trial phase:
- 3
- Study type:
- Targeted therapy, Chemotherapy
- Overall status:
- Completed
Study start date
September, 2021
Scientific title
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) - daNIS-2
Summary
The purpose of this study was to evaluate the efficacy and safety of NIS793 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). This study aimed to explore whether blockade of Transforming Growth Factor β (TGFβ) in combination with gemcitabine/nab-paclitaxel could reduce fibrosis in PDAC, restore chemo-sensitivity and ultimately lead to improvements in overall survival (OS) and other clinically relevant outcomes.
Key
Applicable for both Safety run-in and Randomized part
* Participants aged ≥18 years with histologically or cytologically confirmed (based on local assessment and per local guidelines) mPDAC eligible for treatment in the first line setting and not amenable for potentially curative surgery* Presence of at least one measurable lesion assessed by Computerized Tomography (CT) and/or Magnetic Resonance Imaging (MRI) according to RECIST 1.1 * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 * Adequate organ function (assessed by central laboratory for eligibility) * Participants must have recovered from treatment-related toxicities of prior anticancer therapies to grade ≤ 1 (CTCAE v 5.0) at time of screening, except alopecia.
Key Main
Study design
Primary purpose:
TREATMENT, Allocation:
RANDOMIZED, Intervention model:
PARALLEL, Masking:
QUADRUPLE, Subject masked:
Yes, Caregiver masked:
Yes, Investigator masked:
Yes, Outcomes assessor masked:
Yes,
Conditions
Metastatic Pancreatic Ductal Adenocarcinoma
Other study ID numbers
2021-000591-10; CNIS793B12301
Choose trial site (220)
Highlands Oncology Group
3232 N Northhills Blvd, Fayetteville, AR 72703, USA
US Oncology Research, Dallas
Dallas, TX 75204, USA
Novartis Investigative Site
33 Roberts St W, Osborne Park WA 6017, Australia
Novartis Investigative Site
2820 Bonheiden, Belgium
Novartis Investigative Site
60488 Frankfurt am Main, Germany
Novartis Investigative Site
277-8577, Japan
Novartis Investigative Site
2650 Edegem, Belgium
Novartis Investigative Site
3000 Leuven, Belgium
Novartis Investigative Site
45147 Essen, Germany
Novartis Investigative Site
C. de Serrano Galvache, 56, 28033 Madrid, Spain
Novartis Investigative Site
20249 Hamburg, Germany
Novartis Investigative Site
Jerusalem, Israel
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Omsk Oblast, Russia, 644013
Novartis Investigative Site
Центральный район БЦ "Европа Хаус", Artilleriyskaya Ulitsa, 1, Sankt-Peterburg, Russia, 191014
Novartis Investigative Site
15706 Santiago de Compostela, A Coruña, Spain
Novartis Investigative Site
C. de Serrano Galvache, 56, 28033 Madrid, Spain
Fort Wayne Medical Oncology/Hematology, Inc. Jefferson Blvd
7910 W Jefferson Blvd #108, Fort Wayne, IN 46804, USA
NYU Clinical Cancer Center
160 E 34th St, New York, NY 10016, USA
Houston Methodist Hospital OPC 26
6565 Fannin St, Houston, TX 77030, USA
Novartis Investigative Site
Investigator Dr, Woodcroft SA 5162, Australia
Novartis Investigative Site
Cambridge, ON N1R 3G2, Canada
Novartis Investigative Site
Toronto, ON M4N 3M5, Canada
Novartis Investigative Site
Brno, Czechia
Novartis Investigative Site
741 01, Czechia
Novartis Investigative Site
500 05 Hradec Kralove, Czechia
Novartis Investigative Site
Prague 4, Czechia
Novartis Investigative Site
00290 Helsinki, Finland
Novartis Investigative Site
Tampere, Finland
Novartis Investigative Site
Nice, France
Novartis Investigative Site
25170 Audeux, France
Novartis Investigative Site
Avignon, France
Novartis Investigative Site
6 Pl. Jean Giraudoux, 94000 Créteil, France
Novartis Investigative Site
21000 Dijon, France
Novartis Investigative Site
Lyon, France
Novartis Investigative Site
Marseille, France
Novartis Investigative Site
Saussan, France
Novartis Investigative Site
Nantes, France
Novartis Investigative Site
154 Av. Victor Hugo, 75116 Paris, France
Novartis Investigative Site
13353 Berlin, Germany
Novartis Investigative Site
44791 Bochum, Germany
Novartis Investigative Site
89081 Ulm, Germany
Novartis Investigative Site
Thessaloniki, Greece
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Thermi 570 01, Greece
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Budapest, Hungary
Novartis Investigative Site
Budapest, 1122 Hungary
Novartis Investigative Site
Ramat Gan, Israel
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Totseret ha-Arets St 6, Tel Aviv-Yafo, Israel
Novartis Investigative Site
20133 Milan, Metropolitan City of Milan, Italy
Novartis Investigative Site
37126 Verona, VR, Italy
Novartis Investigative Site
135-8550, Japan
Novartis Investigative Site
Seocho-gu, Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Lørenskog, Norway
Novartis Investigative Site
0450 Oslo, Norway
Novartis Investigative Site
Banská Bystrica, Slovakia
Novartis Investigative Site
Bratislava, Slovakia
Novartis Investigative Site
Košice, Slovakia
Novartis Investigative Site
Carrer de Sardenya, 204, 08013 Barcelona, Spain
Novartis Investigative Site
28040 Madrid, Spain
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6500 Bellinzona, Switzerland
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1211 Geneva, Switzerland
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St Gallen, Switzerland
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Kaohsiung City, Taiwan
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Taipei City, Taiwan
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Taipei City, Taiwan
Novartis Investigative Site
34722 Kadıköy/İstanbul, Turkey
Novartis Investigative Site
Ergene, 35040 Bornova/İzmir, Turkey
Novartis Investigative Site
Büyük Kovanağzı, Sıhhiye, Hasırcılar Sk., 42010 Meram/Konya, Turkey
Novartis Investigative Site
Sutton SM2 5PT, UK
Novartis Investigative Site
Cambridge CB2, UK
Novartis Investigative Site
Headington, Oxford OX3 7LJ, UK
National Cancer Centre Singapore
11 Hospital Crescent, Singapore 169610
National Cancer Center
Highlands Oncology Group .
60 E Monte Painter Dr, Fayetteville, AR 72703, USA
St Bernards Medical Center .
225 E Washington Ave, Jonesboro, AR 72401, USA
UCLA Medical Center Santa Monica Location
1250 16th St, Santa Monica, CA 90404, USA
PIH health
12401 Washington Blvd, Whittier, CA 90602, USA
Advent Health Cancer Institute
2501 N Orange Ave, Orlando, FL 32804, USA
Ochsner Clinic and Hospital
1401 Jefferson Hwy, New Orleans, LA 70121, USA
University of Missouri
Columbia, MO 65212, USA
NYU Clinical Cancer Center Dept of NYU Clin CancerCenter
New York, NY 10016, USA
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Can C
425 E 67th St, New York, NY 10065, USA
Mount Sinai School of Medicine .
1 Gustave L. Levy Pl, New York, NY 10029, USA
Vanderbilt University Medical Center
1211 Medical Center Dr, Nashville, TN 37232, USA
US Oncology Research, Dallas .
Dallas, TX 75204, USA
Huntsman Cancer Institute
2000 Cir of Hope Dr Ste 1950, Salt Lake City, UT 84112, USA
Seattle Cancer Care Alliance
1335 Aloha St, Seattle, WA 98109, USA
Novartis Investigative Site
1000 Brussels, Belgium
Novartis Investigative Site
1200, Belgium
Novartis Investigative Site
SGAS 613 - Asa Sul, Brasília - DF, 70200-730, Brazil
Novartis Investigative Site
R. Siqueira Campos, 1125 - Centro Histórico, Porto Alegre - RS, 90010-001, Brazil
Novartis Investigative Site
Ijuí, RS, 98700-000, Brazil
Novartis Investigative Site
Av. Conselheiro Rodrigues Alves - Vila Mariana, São Paulo - SP, 04014-002, Brazil
Novartis Investigative Site
Brampton, ON L6R 3J7, Canada
Novartis Investigative Site
Montreal, QC H3T 1E2, Canada
Novartis Investigative Site
Xiamen, China, 361001
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Harbin, Heilongjiang, China
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Nanjing, China, 210029
Novartis Investigative Site
Dalian, China, 116001
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Yanzhou District, Jining, China, 272000
Novartis Investigative Site
China, 200032
Novartis Investigative Site
Xi'An, China, 710061
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Wuhou District, Chengdu, China, 610041
Novartis Investigative Site
China, 300060
Novartis Investigative Site
Hangzhou, China, 310022
Novartis Investigative Site
China, 100021
Novartis Investigative Site
Haidian District, China, 100036
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Fuzhou, China, 350001
Novartis Investigative Site
Baiyun, Guangzhou, China, 510000
Novartis Investigative Site
Huangpu, China, 200025
Novartis Investigative Site
Pudong, China, 200127
Novartis Investigative Site
Yangpu District, China, 200433
Novartis Investigative Site
Avignon, France
Novartis Investigative Site
06120 Halle (Saale), Germany
Novartis Investigative Site
Budapest, Hungary
Novartis Investigative Site
Debrecen, 4032 Hungary
Novartis Investigative Site
50134 Firenze FI, Italy
Novartis Investigative Site
20162 Milan, Metropolitan City of Milan, Italy
Novartis Investigative Site
464-8681, Japan
Novartis Investigative Site
241-8515, Japan
Novartis Investigative Site
541-8567, Japan
Novartis Investigative Site
104-0045, Japan
Novartis Investigative Site
3543 Utrecht, Netherlands
Novartis Investigative Site
Nordbyhagen, Norway
Novartis Investigative Site
Singapore 169610
Novartis Investigative Site
08907 L'Hospitalet de Llobregat, Barcelona, Spain
Novartis Investigative Site
Malmö, Sweden
Novartis Investigative Site
Stockholm, Sweden
Novartis Investigative Site
Umeå, Sweden
Novartis Investigative Site
Taoyuan City, Taiwan
Novartis Investigative Site
Yıldırım Beyazıt, 01250 Sarıçam/Adana, Türkiye
Novartis Investigative Site
Birkenhead, Wirral CH63 4JY, UK
Novartis Investigative Site
London EC1A 7BE, UK
Novartis Investigative Site
Dalkeith WA 6009, Australia
Novartis Investigative Site
China, 102206
Novartis Investigative Site
Singapore
University Of California Los Angeles Santa Monica Location
Los Angeles, CA 90095, USA
Novartis Investigative Site
Binhai, China, 300480
Novartis Investigative Site
Taoyuan City, Taiwan
Novartis Investigative Site
China, 200032
Novartis Investigative Site
Binhai, China, 300480