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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04390763




Registration number
NCT04390763
Ethics application status
Date submitted
14/05/2020
Date registered
18/05/2020

Titles & IDs
Public title
Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
Scientific title
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)
Secondary ID [1] 0 0
2020-000349-14
Secondary ID [2] 0 0
CNIS793B12201
Universal Trial Number (UTN)
Trial acronym
daNIS-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Pancreatic Ductal Adenocarcinoma 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - NIS793
Treatment: Other - Spartalizumab
Treatment: Drugs - gemcitabine
Treatment: Drugs - nab-paclitaxel

Experimental: Safety Run-in - Combination of NIS793 + spartalizumab + gemcitabine + nab-paclitaxel

Experimental: Randomized Arm 1 - Combination of NIS793 + spartalizumab + gemcitabine + nab-paclitaxel

Experimental: Randomized Arm 2 - Combination of NIS793 + gemcitabine + nab-paclitaxel

Active comparator: Randomized Arm 3 - gemcitabine + nab-paclitaxel


Treatment: Other: NIS793
anti-TGFb antibody

Treatment: Other: Spartalizumab
anti-PD-1 antibody

Treatment: Drugs: gemcitabine
SOC chemotherapy

Treatment: Drugs: nab-paclitaxel
SOC chemotherapy
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of DLTs during the Safety Run-in
Timepoint [1] 0 0
4 weeks
Primary outcome [2] 0 0
Incidence and severity of treatment emergent Adverse Events and Serious Adverse Events in Safety Run-in
Timepoint [2] 0 0
8 months
Primary outcome [3] 0 0
Dose interruptions/reductions in Safety Run-in
Timepoint [3] 0 0
8 months
Primary outcome [4] 0 0
Dose intensity in Safety Run-in
Timepoint [4] 0 0
8 months
Primary outcome [5] 0 0
Progression-free survival in Randomized part
Timepoint [5] 0 0
18 months
Secondary outcome [1] 0 0
Incidence and severity of Adverse Events and Serious Adverse Events in Randomized part
Timepoint [1] 0 0
18 months
Secondary outcome [2] 0 0
Dose interruption/reduction in Randomized part
Timepoint [2] 0 0
18 months
Secondary outcome [3] 0 0
Dose intensity in Randomized part
Timepoint [3] 0 0
18 months
Secondary outcome [4] 0 0
Overall response rate per RECIST 1.1 in Randomized part
Timepoint [4] 0 0
18 months
Secondary outcome [5] 0 0
Duration of response per RECIST 1.1 in Randomized part
Timepoint [5] 0 0
18 months
Secondary outcome [6] 0 0
Time to Progression per RECIST 1.1 in Randomized part
Timepoint [6] 0 0
18 months
Secondary outcome [7] 0 0
Overall Survival per RECIST 1.1 in Randomized part
Timepoint [7] 0 0
18 months
Secondary outcome [8] 0 0
CD8 and PD-L1 expression in Randomized part
Timepoint [8] 0 0
18 months
Secondary outcome [9] 0 0
Antidrug antibodies (ADA) (anti-NIS793 and anti-spartalizumab) expression in Randomized part
Timepoint [9] 0 0
18 months
Secondary outcome [10] 0 0
Pharmacokinetic (PK) parameter Cmax in Randomized part
Timepoint [10] 0 0
12 months
Secondary outcome [11] 0 0
Pharmacokinetic parameter AUClast in Randomized part
Timepoint [11] 0 0
12 months
Secondary outcome [12] 0 0
Pharmacokinetic parameter Ctrough
Timepoint [12] 0 0
12 months

Eligibility
Key inclusion criteria
1. Signed informed consent must be obtained prior to participation in the study.
2. Male or female = 18 years of age at the time of informed consent.
3. Participants with histologically or cytologically confirmed treatment-naïve metastatic adenocarcinoma of the pancreas with measurable disease as per RECIST 1.1.
4. 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.
5. ECOG performance status = 1.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 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.
2. Participants amenable to potentially curative resection.
3. Participants with a diagnosis of pancreatic neuroendocrine tumors (NETs), acinar, or islet cell tumors.
4. Having out of range laboratory values as pre-defined in the protocol.
5. Participants with MSI-H pancreatic adenocarcinoma.
6. 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.
7. History of severe hypersensitivity reactions to any ingredient of study drug(s) and other mAbs and/or their excipients.
8. 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.
9. Impaired cardiac function or clinically significant cardiac disease.
10. Known history of testing positive HIV infection.
11. Active HBV or HCV infection. Participants whose disease is controlled under antiviral therapy should not be excluded.
12. History of or current interstitial lung disease or pneumonitis grade = 2
13. High risk of clinically significant gastrointestinal tract bleeding or any other condition associated with or history of significant bleeding.

Other protocol-defined inclusion/exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/05/2024
Sample size
Target
Accrual to date
Final
164
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Westmead
Recruitment hospital [2] 0 0
Novartis Investigative Site - Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
Austria
State/province [5] 0 0
Salzburg
Country [6] 0 0
Austria
State/province [6] 0 0
Wien
Country [7] 0 0
Belgium
State/province [7] 0 0
Liege
Country [8] 0 0
Czechia
State/province [8] 0 0
Czech Republic
Country [9] 0 0
Finland
State/province [9] 0 0
Helsinki
Country [10] 0 0
France
State/province [10] 0 0
Paris 10
Country [11] 0 0
France
State/province [11] 0 0
Toulouse 4
Country [12] 0 0
Germany
State/province [12] 0 0
Essen
Country [13] 0 0
Germany
State/province [13] 0 0
Heidelberg
Country [14] 0 0
Germany
State/province [14] 0 0
Ulm
Country [15] 0 0
Italy
State/province [15] 0 0
MI
Country [16] 0 0
Italy
State/province [16] 0 0
VR
Country [17] 0 0
Singapore
State/province [17] 0 0
Singapore
Country [18] 0 0
Spain
State/province [18] 0 0
Catalunya
Country [19] 0 0
Spain
State/province [19] 0 0
Madrid
Country [20] 0 0
Switzerland
State/province [20] 0 0
St. Gallen
Country [21] 0 0
Switzerland
State/province [21] 0 0
Zurich
Country [22] 0 0
Taiwan
State/province [22] 0 0
Taichung
Country [23] 0 0
Taiwan
State/province [23] 0 0
Taipei
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04390763