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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04390763
Registration number
NCT04390763
Ethics application status
Date submitted
14/05/2020
Date registered
18/05/2020
Date last updated
17/05/2024
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)
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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)
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Secondary ID [1]
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2020-000349-14
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Secondary ID [2]
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CNIS793B12201
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Universal Trial Number (UTN)
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Trial acronym
daNIS-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Pancreatic Ductal Adenocarcinoma
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - NIS793
Other interventions - 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
Other interventions: NIS793
anti-TGFb antibody
Other interventions: Spartalizumab
anti-PD-1 antibody
Treatment: Drugs: gemcitabine
SOC chemotherapy
Treatment: Drugs: nab-paclitaxel
SOC chemotherapy
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of DLTs during the Safety Run-in
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Assessment method [1]
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Incidence of DLTs to assess the safety and tolerability of NIS793 + spartalizumab in combination with gemcitabine/nab-paclitaxel
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Timepoint [1]
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4 weeks
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Primary outcome [2]
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Incidence and severity of treatment emergent Adverse Events and Serious Adverse Events in Safety Run-in
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Assessment method [2]
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Safety and tolerability measured by appearance of (or worsening of any pre-existing condition) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient signed informed consent.
A Serious Adverse Event (SAE) is defined as one of the following:
Is fatal or life threatening
Results in persistent or significant disability/incapacity
Constitutes a congenital anomaly/birth defect
Is medical significant
Requires inpatient hospitalization or prolongation of existing hospitalization.
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Timepoint [2]
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8 months
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Primary outcome [3]
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Dose interruptions/reductions in Safety Run-in
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Assessment method [3]
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Tolerability of NIS793 + spartalizumab in combination with gemcitabine/nab-paclitaxel measured by the number of subjects with at least one dose interruption/reduction of study treatment and reason
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Timepoint [3]
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8 months
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Primary outcome [4]
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Dose intensity in Safety Run-in
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Assessment method [4]
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Tolerability of NIS793 + spartalizumab in combination with gemcitabine/nab-paclitaxel measured by the dose intensity of study treatment for subjects with non-zero duration of exposure computed as the ratio of dose intensity and planned dose intensity
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Timepoint [4]
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8 months
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Primary outcome [5]
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Progression-free survival in Randomized part
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Assessment method [5]
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PFS as per Response Evaluation Criteria in Solid Tumors (RECIST1.1) as per local Investigator's review, to evaluate the PFS of NIS793 with and without spartalizumab in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel
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Timepoint [5]
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18 months
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Secondary outcome [1]
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Incidence and severity of Adverse Events and Serious Adverse Events in Randomized part
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Assessment method [1]
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Safety and tolerability measured by appearance of (or worsening of any pre-existing condition) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient signed informed consent.
A Serious Adverse Event (SAE) is defined as one of the following:
Is fatal or life threatening
Results in persistent or significant disability/incapacity
Constitutes a congenital anomaly/birth defect
Is medical significant
Requires inpatient hospitalization or prolongation of existing hospitalization.
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Timepoint [1]
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18 months
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Secondary outcome [2]
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Dose interruption/reduction in Randomized part
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Assessment method [2]
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Tolerability of NIS793 +/- spartalizumab in combination with gemcitabine/nab-paclitaxel measured by the number of subjects with at least one dose interruption/reduction of study treatment and reason
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Timepoint [2]
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18 months
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Secondary outcome [3]
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Dose intensity in Randomized part
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Assessment method [3]
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Tolerability of NIS793 +/- spartalizumab in combination with gemcitabine/nab-paclitaxel measured by the dose intensity of study treatment for subjects with non-zero duration of exposure computed as the ratio of dose intensity and planned dose intensity
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Timepoint [3]
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18 months
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Secondary outcome [4]
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Overall response rate per RECIST 1.1 in Randomized part
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Assessment method [4]
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ORR per RECIST 1.1 to assess the preliminary anti-tumor activity of NIS793 with and without spartalizumab in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel
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Timepoint [4]
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18 months
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Secondary outcome [5]
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Duration of response per RECIST 1.1 in Randomized part
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Assessment method [5]
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DOR per RECIST 1.1 to assess the preliminary anti-tumor activity of NIS793 with and without spartalizumab in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel
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Timepoint [5]
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18 months
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Secondary outcome [6]
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Time to Progression per RECIST 1.1 in Randomized part
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Assessment method [6]
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TTP per RECIST 1.1 to assess the preliminary anti-tumor activity of NIS793 with and without spartalizumab in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel
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Timepoint [6]
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18 months
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Secondary outcome [7]
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Overall Survival per RECIST 1.1 in Randomized part
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Assessment method [7]
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OS per RECIST 1.1 to assess the preliminary anti-tumor activity of NIS793 with and without spartalizumab in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel
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Timepoint [7]
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18 months
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Secondary outcome [8]
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CD8 and PD-L1 expression in Randomized part
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Assessment method [8]
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Change from baseline in CD8 and PD-L1 IHC related markers to assess the CD8 and PD-L1 status of the participants at screening and on treatment versus gemcitabine/nab-paclitaxel
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Timepoint [8]
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18 months
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Secondary outcome [9]
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Antidrug antibodies (ADA) (anti-NIS793 and anti-spartalizumab) expression in Randomized part
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Assessment method [9]
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Antidrug antibodies (ADA) prevalence at baseline and ADA incidence on-treatment (anti-NIS793 and anti-spartalizumab) to characterize the incidence of immunogenicity of NIS793 and spartalizumab in combination with gemcitabine/nab-paclitaxel
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Timepoint [9]
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18 months
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Secondary outcome [10]
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Pharmacokinetic (PK) parameter Cmax in Randomized part
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Assessment method [10]
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To characterize the pharmacokinetics (PK) of NIS793, spartalizumab, gemcitabine/nab-paclitaxel in combination treatment or alone (gemcitabine/nab-paclitaxel)
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Timepoint [10]
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12 months
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Secondary outcome [11]
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Pharmacokinetic parameter AUClast in Randomized part
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Assessment method [11]
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To characterize the pharmacokinetics (PK) of NIS793, spartalizumab, gemcitabine/nab-paclitaxel in combination treatment or alone (gemcitabine/nab-paclitaxel)
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Timepoint [11]
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12 months
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Secondary outcome [12]
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Pharmacokinetic parameter Ctrough
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Assessment method [12]
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To characterize the pharmacokinetics (PK) of NIS793, spartalizumab, gemcitabine/nab-paclitaxel in combination treatment or alone (gemcitabine/nab-paclitaxel)
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Timepoint [12]
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12 months
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/10/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
2/05/2024
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Sample size
Target
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Accrual to date
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Final
164
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Westmead
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Recruitment hospital [2]
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Novartis Investigative Site - Melbourne
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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3000 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Georgia
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United States of America
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State/province [2]
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Maryland
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United States of America
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State/province [3]
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Massachusetts
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Country [4]
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United States of America
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State/province [4]
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Pennsylvania
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Country [5]
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Austria
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State/province [5]
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Salzburg
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Country [6]
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Austria
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State/province [6]
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Wien
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Belgium
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State/province [7]
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Liege
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Country [8]
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Czechia
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State/province [8]
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Czech Republic
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Finland
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State/province [9]
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Helsinki
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Country [10]
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France
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State/province [10]
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Paris 10
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France
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State/province [11]
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Toulouse 4
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Germany
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State/province [12]
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Essen
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Germany
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State/province [13]
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Heidelberg
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Country [14]
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Germany
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State/province [14]
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Ulm
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Italy
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State/province [15]
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MI
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Country [16]
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Italy
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State/province [16]
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VR
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Country [17]
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Singapore
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State/province [17]
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Singapore
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Country [18]
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Spain
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State/province [18]
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Catalunya
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Spain
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State/province [19]
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Madrid
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Country [20]
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Switzerland
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State/province [20]
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St. Gallen
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Switzerland
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State/province [21]
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Zurich
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Country [22]
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Taiwan
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State/province [22]
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Taichung
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Taiwan
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State/province [23]
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Taipei
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Country [24]
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United Kingdom
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State/province [24]
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04390763
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04390763
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