Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) (daNIS-1)

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)

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 previously untreated mPDAC.

Study Overview

• Status: Terminated
• Conditions: Metastatic Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Biological: NIS793; Biological: Spartalizumab; Drug: gemcitabine; Drug: nab-paclitaxel

Detailed Description

This is a randomized, parallel arms, open-label, multi-center, Phase II study to evaluate the efficacy and safety of NIS793 with and without spartalizumab in combination with gemcitabine/nab-paclitaxel in participants with first-line metastatic pancreatic ductal adenocarcinoma (mPDAC).

The study started with a Safety Run-in to assess the safety and tolerability of NIS793 in combination with spartalizumab and standard of care (SOC) gemcitabine/nab-paclitaxel. Doses defined for each study treatment, as part of this quadruplet were administered in the Randomized part in the quadruplet/triplet/doublet-based treatment arms.

The Randomized part opened after the Safety Run-in had completed. Participants were randomized in a 1:1:1 ratio to one of the three treatment arms:

• Arm 1: NIS793 with spartalizumab and gemcitabine/nab-paclitaxel
• Arm 2: NIS793 with gemcitabine/nab-paclitaxel
• Arm 3: gemcitabine/nab-paclitaxel

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Novartis Investigative Site
  • Victoria
    • Melbourne, Victoria, Australia, 3000
      • Novartis Investigative Site
• Austria
  • Salzburg, Austria, 5020
    • Novartis Investigative Site
  • Vienna, Austria, A-1090
    • Novartis Investigative Site
• Belgium
  • Liège, Belgium, 4000
    • Novartis Investigative Site
• Czechia
  • Czech Republic
    • Brno, Czech Republic, Czechia, 656 53
      • Novartis Investigative Site
• Finland
  • Helsinki, Finland, FIN-00029
    • Novartis Investigative Site
• France
  • Paris, France, 75475
    • Novartis Investigative Site
  • Toulouse, France, 31054
    • Novartis Investigative Site
• Germany
  • Essen, Germany, 45147
    • Novartis Investigative Site
  • Heidelberg, Germany, 69120
    • Novartis Investigative Site
  • Ulm, Germany, 89081
    • Novartis Investigative Site
• Italy
  • MI
    • Milan, MI, Italy, 20141
      • Novartis Investigative Site
    • Milan, MI, Italy, 20132
      • Novartis Investigative Site
    • Rozzano, MI, Italy, 20089
      • Novartis Investigative Site
  • VR
    • Verona, VR, Italy, 37134
      • Novartis Investigative Site
• Singapore
  • Singapore, Singapore, 119074
    • Novartis Investigative Site
  • Singapore, Singapore, 168583
    • Novartis Investigative Site
• Spain
  • Madrid, Spain, 28050
    • Novartis Investigative Site
  • Catalonia
    • Barcelona, Catalonia, Spain, 08035
      • Novartis Investigative Site
    • Barcelona, Catalonia, Spain, 08036
      • Novartis Investigative Site
• Switzerland
  • Sankt Gallen, Switzerland, 9007
    • Novartis Investigative Site
  • Zurich, Switzerland, 8091
    • Novartis Investigative Site
• Taiwan
  • Taichung, Taiwan, 40447
    • Novartis Investigative Site
  • Taipei, Taiwan, 10002
    • Novartis Investigative Site
• United Kingdom
  • Oxford, United Kingdom, OX3 7LE
    • Novartis Investigative Site
• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Sidney Kimmel CCC At JH
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Cente
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • Univ of Pittsburgh Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Safety Run-in; Combination of NIS793 + spartalizumab + gemcitabine + nab-paclitaxel	Biological: NIS793; anti-TGFb antibody. NIS793 2100 mg every 2 weeks by intravenous (i.v.) infusion.; Biological: Spartalizumab; anti-PD-1 antibody. spartalizumab 400 mg every 4 weeks by i.v. infusion.; Other Names: PDR001; Drug: gemcitabine; SOC chemotherapy. Gemcitabine (1000 mg/m^2 on Days 1, 8, and 15) i.v. given as per label.; Drug: nab-paclitaxel; SOC chemotherapy. Nab-paclitaxel (125 mg/m^2 on Days 1, 8, and 15) i.v. given as per label.; Other Names: abraxane
Experimental: Randomized Arm 1; Combination of NIS793 + spartalizumab + gemcitabine + nab-paclitaxel	Biological: NIS793; anti-TGFb antibody. NIS793 2100 mg every 2 weeks by intravenous (i.v.) infusion.; Biological: Spartalizumab; anti-PD-1 antibody. spartalizumab 400 mg every 4 weeks by i.v. infusion.; Other Names: PDR001; Drug: gemcitabine; SOC chemotherapy. Gemcitabine (1000 mg/m^2 on Days 1, 8, and 15) i.v. given as per label.; Drug: nab-paclitaxel; SOC chemotherapy. Nab-paclitaxel (125 mg/m^2 on Days 1, 8, and 15) i.v. given as per label.; Other Names: abraxane
Experimental: Randomized Arm 2; Combination of NIS793 + gemcitabine + nab-paclitaxel	Biological: NIS793; anti-TGFb antibody. NIS793 2100 mg every 2 weeks by intravenous (i.v.) infusion.; Drug: gemcitabine; SOC chemotherapy. Gemcitabine (1000 mg/m^2 on Days 1, 8, and 15) i.v. given as per label.; Drug: nab-paclitaxel; SOC chemotherapy. Nab-paclitaxel (125 mg/m^2 on Days 1, 8, and 15) i.v. given as per label.; Other Names: abraxane
Active Comparator: Randomized Arm 3; gemcitabine + nab-paclitaxel	Drug: gemcitabine; SOC chemotherapy. Gemcitabine (1000 mg/m^2 on Days 1, 8, and 15) i.v. given as per label.; Drug: nab-paclitaxel; SOC chemotherapy. Nab-paclitaxel (125 mg/m^2 on Days 1, 8, and 15) i.v. given as per label.; Other Names: abraxane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety run-in Part: Number of Participants With Dose-Limiting Toxicities (DLTs)	A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 where the relationship to study treatment cannot be ruled out and is not clearly related solely to disease, disease progression, inter-current illness or concomitant medications, which occurs within the DLT evaluation period. The DLT evaluation period is the first 28 days of treatment with NIS793 with spartalizumab in combination with gemcitabine/nab-paclitaxel. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.	First cycle of treatment (28 days)
Safety run-in Part: Number of Participants With AEs and SAEs During the On-treatment Period	Number of participants with AEs (any adverse events regardless of seriousness) and serious adverse events (SAEs), including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. AE grades to characterize the severity of the AEs were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. For CTCAE v5.0, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE. The on-treatment period is defined from the day of first administration of any study treatment up to 30 days after the date of the last actual administration of any study drug.	Up to approximately 0.8 years
Safety run-in Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel	Number of participants with at least one dose reduction and at least one dose interruption of study drugs. Dose adjustments were permitted for patients who did not tolerate the protocol-specified dosing schedule. No dose reductions were allowed for NIS793 and spartalizumab beyond the first 28 days period of Safety run-in part.	Up to approximately 0.7 years
Safety run-in Part: Dose Intensity of NIS793 and Spartalizumab	Dose intensity of NIS973 and spartalizumab was calculated as cumulative actual dose in milligrams divided by duration of exposure in days and multiplied by 28 days. Dose adjustments were permitted for patients who did not tolerate the protocol-specified dosing schedule.	Cycle 1 and Cycle 3. The duration of each cycle was 28 days.
Safety run-in Part: Dose Intensity of Gemcitabine and Nab-paclitaxel	Dose intensity of gemcitabine and nab-paclitaxel was calculated as cumulative actual dose in milligrams/m^2 divided by duration of exposure in days and multiplied by 28 days.	Cycle 1 and Cycle 3. The duration of each cycle was 28 days.
Randomized Part: Progression-Free Survival (PFS) Per RECIST v1.1 - Bayesian Model	PFS was based on local review of tumor assessments, using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria. PFS is defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. If a subject had not had an event, PFS was censored at the date of last adequate tumor assessment. PFS was estimated using a Bayesian model. For each comparison (arm 1 versus arm 3 and arm 2 versus arm 3), PFS was modeled using a two-piece hazard model, with specifying hazard rates before and after the possible delayed effect for arms 1 and 2 and constant hazard rate for arm 3. Results in the table as expressed as estimated posterior median hazard rate and one-sided 90% credible interval.	Up to approximately 2 years. Risk changing timepoint=approximately 0.3 years.
Randomized Part: Progression-Free Survival (PFS) Per RECIST v1.1 - Kaplan-Meier Curves and Cox Model	PFS was based on local review of tumor assessments, using RECIST 1.1 criteria. PFS is defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. If a subject had not had an event, PFS was censored at the date of last adequate tumor assessment. PFS was analyzed based on the Kaplan-Meier curves and the Cox model.	Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Randomized Part: Number of Participants With AEs and SAEs During the On-treatment Period	Number of participants with AEs (any adverse events regardless of seriousness) and serious adverse events (SAEs), including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. AE grades to characterize the severity of the AEs were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. For CTCAE v5.0, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE. The on-treatment period is defined from the day of first administration of any study treatment up to 30 days after the date of the last actual administration of any study drug.	Up to approximately 1.8 years
Randomized Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel	Number of participants with at least one dose reduction and at least one dose interruption of study drugs. Dose adjustments were permitted for patients who did not tolerate the protocol-specified dosing schedule. No dose reductions were allowed for NIS793 and spartalizumab in the Randomized part.	Up to approximately 1.7 years
Randomized Part: Dose Intensity of NIS973 and Spartalizumab	Dose intensity of NIS973 and spartalizumab was calculated as cumulative actual dose in milligrams divided by duration of exposure in days and multiplied by 28 days. Dose adjustments were permitted for patients who did not tolerate the protocol-specified dosing schedule.	Cycle 1 and Cycle 3. The duration of each cycle was 28 days
Randomized Part: Dose Intensity of Gemcitabine and Nab-paclitaxel	Dose intensity of gemcitabine and nab-paclitaxel was calculated as cumulative actual dose in milligrams/m^2 divided by duration of exposure in days and multiplied by 28 days.	Cycle 1 and Cycle 3. The duration of each cycle was 28 days
Randomized Part: Overall Response Rate (ORR) Per RECIST v1.1	ORR is the percentage of patients with a confirmed best overall response of complete response (CR) or partial response (PR), based on local investigator assessment per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1. For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.	Up to approximately 1.7 years
Randomized Part: Duration of Response (DOR) Per RECIST v1.1	DOR per RECIST v1.1 is defined as the time from the first documented response of CR or PR to the date of the first documented progression or death. DOR only applies to patients with a best overall response of CR or PR by investigator assessment per RECIST v1.1. Participants continuing without progression or death were censored at the date of their last adequate tumor assessment. DOR was analyzed using the Kaplan-Meier method.	Up to approximately 1.7 years
Randomized Part: Time to Progression (TTP) Per RECIST v1.1	TTP per RECIST v1.1 is defined as the time from the date of randomization to the date of event defined as the first documented progression per RECIST v1.1 or death due to underlying cancer. If a participant had no progression or death, the participant was censored at the date of last adequate tumor assessment. DOR was analyzed using the Kaplan-Meier method.	Up to approximately 1.7 years
Randomized Part: Overall Survival (OS)	Overall survival is defined as the time from the date of randomization to the date of death due to any cause. OS was analyzed using the Kaplan-Meier method.	Up to approximately 2 years
Randomized Part: Change From Baseline in PD-L1 Expression	The tumor expression of programmed cell death-ligand 1 (PD-L1) was measured by immunohistochemical methods. Results are expressed as absolute change from baseline in PD-L1 expression.	Baseline (Screening), on-treatment (anytime between Cycle 3 Day 2 and Day 4). The duration of each cycle was 28 days.
Randomized Part: Change From Baseline in CD8 Expression	The tumor expression of CD8 was measured by immunohistochemical methods. Results are expressed as absolute change from baseline in CD8 expression.	Baseline (Screening), on-treatment (anytime between Cycle 3 Day 2 and Day 4). The duration of each cycle was 28 days.
Randomized Part: Number of Participants With Anti-NIS793 Antibodies	The immunogenicity (IG) against NIS793 was assessed in serum using a validated enhanced electrochemiluminescence immunoassay (ECLIA). Patient anti-drug antibodies (ADA) status was defined as follows: ADA-negative at baseline: ADA-negative sample at baseline; ADA-positive at baseline: ADA-positive sample at baseline; ADA-negative post-baseline: patient with ADA-negative sample at baseline and at least 1 post baseline sample, all of which are ADA-negative samples; ADA-inconclusive post-baseline = patient who does not qualify as ADA-positive or ADA-negative post-baseline; Treatment-induced ADA-positive = ADA-negative sample at baseline and at least 1 treatment-induced ADA-positive sample	Baseline (before first dose) and post-baseline (assessed throughout the treatment up to approximately 1.7 years)
Randomized Part: Number of Participants With Anti-spartalizumab Antibodies	The immunogenicity (IG) against spartalizumab was assessed in serum using a validated a validated homogenous enzyme-linked immunosorbent assay (ELISA). Patient anti-drug antibodies (ADA) status was defined as follows: ADA-negative at baseline: ADA-negative sample at baseline; ADA-inconclusive at baseline: patient who does not qualify as ADA-positive or ADA-negative at baseline; ADA-positive at baseline: ADA-positive sample at baseline; ADA-negative post-baseline: patient with ADA-negative sample at baseline and at least 1 post baseline sample, all of which are ADA-negative samples; ADA-inconclusive post-baseline = patient who does not qualify as ADA-positive or ADA-negative post-baseline; Treatment-induced ADA-positive = ADA-negative sample at baseline and at least 1 treatment-induced ADA-positive sample	Cycle 1 and Cycle 3. The duration of each cycle was 28 days
Randomized Part: Maximum Observed Serum Concentration (Cmax) of NIS793	Pharmacokinetic (PK) parameters were calculated based on NIS793 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed concentration following a dose.	Cycle 1 and Cycle 3: pre-dose, 1, 24, 168 and 336 hours after the end of the infusion on Day 1. The duration of the infusion was 30 minutes. One cycle=28 days
Randomized Part: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of NIS793	PK parameters were calculated based on NIS793 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUClast calculation.	Cycle 1 and Cycle 3: pre-dose, 1, 24, 168 and 336 hours after the end of the infusion on Day 1. The duration of the infusion was 30 minutes. One cycle=28 days
Randomized Part: Trough Serum Concentration (Ctrough) of NIS793	Ctrough is defined as the concentration reached immediately before the next dose is administered. All drug concentrations below the lower limit of quantification were treated as zero for the calculation of PK parameters.	Cycle 1: pre-dose on Day 1. Cycle 3: pre-dose on Day 1 and Day 15 (combined). One cycle=28 days
Randomized Part: Maximum Observed Serum Concentration (Cmax) of Spartalizumab	PK parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed concentration following a dose.	Cycle 1 and Cycle 3: pre-dose, 1, 24, 168 and 648 hours after the end of the infusion on Day 1. The duration of the infusion was 30 minutes. One cycle=28 days
Randomized Part: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Spartalizumab	PK parameters were calculated based on spartalizumab serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUClast calculation.	Cycle 1 and Cycle 3: pre-dose, 1, 24, 168 and 648 hours after the end of the infusion on Day 1. The duration of the infusion was 30 minutes. One cycle=28 days
Randomized Part: Trough Serum Concentration (Ctrough) of Spartalizumab	Ctrough is defined as the concentration reached immediately before the next dose is administered. All drug concentrations below the lower limit of quantification were treated as zero for the calculation of PK parameters.	Cycle 2, 3 and 4: pre-dose on Day 1. One cycle=28 days
Randomized Part: Maximum Observed Plasma Concentration (Cmax) of Gemcitabine	PK parameters were calculated based on gemcitabine plasma concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed concentration following a dose.	Cycle 1 and Cycle 4: pre-dose, end of infusion, and 2, 3, 5 and 24 hours after the start of infusion on Day 1. The duration of the infusion was according to the product labelling and local guidance. One cycle=28 days
Randomized Part: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Gemcitabine	PK parameters were calculated based on gemcitabine plasma concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUClast calculation.	Cycle 1 and Cycle 4: pre-dose, end of infusion, and 2, 3, 5 and 24 hours after the start of infusion on Day 1. The duration of the infusion was according to the product labelling and local guidance. One cycle=28 days
Randomized Part: Trough Serum Concentration (Ctrough) of Gemcitabine	Ctrough is defined as the concentration reached immediately before the next dose is administered. All drug concentrations below the lower limit of quantification were treated as zero for the calculation of PK parameters.	Cycle 4: pre-dose on Day 1. One cycle=28 days
Randomized Part: Maximum Observed Plasma Concentration (Cmax) of Nab-paclitaxel	PK parameters were calculated based on nab-paclitaxel plasma concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed concentration following a dose.	Cycle 1 and Cycle 4: pre-dose, end of infusion, and 2, 3, 5 and 24 hours after the start of infusion on Day 1. The duration of the infusion was according to the product labelling and local guidance. One cycle=28 days
Randomized Part: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Nab-paclitaxel	PK parameters were calculated based on nab-paclitaxel plasma concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUClast calculation.	Cycle 1 and Cycle 4: pre-dose, end of infusion, and 2, 3, 5 and 24 hours after the start of infusion on Day 1. The duration of the infusion was according to the product labelling and local guidance. One cycle=28 days
Randomized Part: Trough Serum Concentration (Ctrough) of Nab-paclitaxel	Ctrough is defined as the concentration reached immediately before the next dose is administered. All drug concentrations below the lower limit of quantification were treated as zero for the calculation of PK parameters.	Cycle 4: pre-dose on Day 1. One cycle=28 days

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• A Plain Language Trial Summary is available on www.novctrd.com

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2020
• Primary Completion (Actual): April 26, 2024
• Study Completion (Actual): May 2, 2024

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Estimated): October 16, 2025
• Last Update Submitted That Met QC Criteria: October 8, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: PD-1; gemcitabine; Phase II; spartalizumab; nab-paclitaxel; TGFβ; mPDAC; NIS793
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Adenocarcinoma; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Taxoids; Cyclodecanes; Diterpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Albumins; Paclitaxel; Albumin-Bound Paclitaxel; Gemcitabine; 130-nm albumin-bound paclitaxel; spartalizumab; NIS-793
• Other Study ID Numbers: CNIS793B12201; 2020-000349-14 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No