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

A Phase II, Open Label, Randomized, Parallel Arm Study of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy Gemcitabine/Nab-paclitaxel, and Gemcitabine/Nab-paclitaxel Alone in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

ClinicalTrials.gov Identifier: NCT04390763

Novartis Reference Number: CNIS793B12201

Last Update: Mar 18, 2021

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this Phase II study is to assess the efficacy and safety of NIS793 with and without spartalizumab in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in untreated mPDAC.

Condition 
Metastatic Pancreatic Ductal Adenocarcinoma
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
156 participants
Start date 
Oct 16, 2020
Completion date 
Aug 04, 2022
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Biological
NIS793
anti-TGFb antibody
Biological
Spartalizumab
anti-PD-1 antibody
Drug
gemcitabine
SOC chemotherapy
Drug
nab-paclitaxel
SOC chemotherapy

Eligibility Criteria

Inclusion Criteria:

Signed informed consent must be obtained prior to participation in the study.
Male or female ≥ 18 years of age at the time of informed consent.
Participants with histologically or cytologically confirmed treatment-naïve metastatic adenocarcinoma of the pancreas with measurable disease as per RECIST 1.1.
Participants must have a site of disease amenable to biopsy, and be candidate for tumor biopsy according to the treating institution's guidelines. Participants must be willing to undergo a tumor biopsy at screening and during therapy on the study. In the event a new biopsy cannot be safely performed at study entry, an archival sample (collected <6 months prior) may be substituted following documented discussion with Novartis.
ECOG performance status ≤ 1.

Exclusion Criteria:

Previous radiotherapy, surgery (with exception of placement of biliary stent, which is allowed), chemotherapy or any other investigational therapy for the treatment of metastatic pancreatic cancer. Participants having received previous chemotherapy in the adjuvant setting.
Participants amenable to potentially curative resection.
Participants with a diagnosis of pancreatic neuroendocrine tumors (NETs), acinar, or islet cell tumors.
Having out of range laboratory values as pre-defined in the protocol.
Participants with MSI-H pancreatic adenocarcinoma.
Presence of symptomatic CNS metastases, or CNS metastases that require local CNS directed therapy (such as radiotherapy or surgery), or increasing doses of corticosteroids 2 weeks prior to study entry.
History of severe hypersensitivity reactions to any ingredient of study drug(s) and other mAbs and/or their excipients.
The participant exhibits any of the events outlined in the contra-indications or special warnings and precautions sections of gemcitabine and nab-paclitaxel as per locally approved labels.
Impaired cardiac function or clinically significant cardiac disease.
Known history of testing positive HIV infection.
Active HBV or HCV infection. Participants whose disease is controlled under antiviral therapy should not be excluded.
History of or current interstitial lung disease or pneumonitis grade ≥ 2

Study Locations

United States
University of Pittsburgh Cancer Institute HIllman Cancer Center
Recruiting
Pittsburgh, 15232
Pennsylvania
United States
Australia
Novartis Investigative Site
Recruiting
Westmead, 2145
New South Wales
Australia
Novartis Investigative Site
Recruiting
Melbourne, 3000
Victoria
Australia
Austria
Novartis Investigative Site
Recruiting
Salzburg, 5020
-
Austria
Belgium
Novartis Investigative Site
Recruiting
Liege, 4000
-
Belgium
Czech Republic
Novartis Investigative Site
Recruiting
Brno, 656 53
Czech Republic
Czech Republic
Finland
Novartis Investigative Site
Recruiting
HUS, FIN-00029
-
Finland
France
Novartis Investigative Site
Recruiting
Paris Cedex 10, 75475
-
France
Novartis Investigative Site
Recruiting
Toulouse Cedex 4, 31054
-
France
Germany
Novartis Investigative Site
Recruiting
Essen, 45147
-
Germany
Novartis Investigative Site
Recruiting
Ulm, 89081
-
Germany
Italy
Novartis Investigative Site
Recruiting
Rozzano, 20089
MI
Italy
Novartis Investigative Site
Recruiting
Verona, 37126
VR
Italy
Singapore
Novartis Investigative Site
Recruiting
Singapore, 119074
-
Singapore
Novartis Investigative Site
Recruiting
Singapore, 169610
-
Singapore
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
Recruiting
Madrid, 28050
-
Spain
Switzerland
Novartis Investigative Site
Recruiting
St. Gallen, 9007
-
Switzerland
Novartis Investigative Site
Recruiting
Zurich, 8091
-
Switzerland
Taiwan
Novartis Investigative Site
Recruiting
Taipei, 10002
-
Taiwan
United Kingdom
Novartis Investigative Site
Recruiting
Oxford, OX3 7LJ
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

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