Clinical Trials List
Protocol NumberCNIS793B12201
NCT Number(ClinicalTrials.gov Identfier)NCT04390763
Completed
2020-09-01 - 2025-07-29
Phase II
Not yet recruiting1
Recruiting1
ICD-10C25.3
Malignant neoplasm of pancreatic duct
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9157.3
Malignant neoplasm of pancreatic duct
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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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
Novartis Pharmaceuticals
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- SHIH-HUNG YANG 無
- SHIH-HUNG YANG 未分科
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
Objectives
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.
Test Drug
NIS793PDR001
Active Ingredient
NIS793
PDR001 (Spartalizumab)
PDR001 (Spartalizumab)
Dosage Form
Powder for solution for infusion
Concentrate for solution for infusion
Concentrate for solution for infusion
Dosage
100
100
100
Endpoints
Primary Outcome Measures :
Incidence of DLTs during the Safety Run-in [ Time Frame: 3 months ]
Incidence of DLTs to assess the safety and tolerability of NIS793 + spartalizumab in combination with gemcitabine/nab-paclitaxel
Incidence and severity of treatment emergent Adverse Events and Serious Adverse Events in Safety Run-in [ Time Frame: 3 months ]
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.
Dose interruptions/reductions in Safety Run-in [ Time Frame: 3 months ]
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
Dose intensity in Safety Run-in [ Time Frame: 3 months ]
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
Progression-free survival in Randomized part [ Time Frame: 18 months ]
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
Incidence of DLTs during the Safety Run-in [ Time Frame: 3 months ]
Incidence of DLTs to assess the safety and tolerability of NIS793 + spartalizumab in combination with gemcitabine/nab-paclitaxel
Incidence and severity of treatment emergent Adverse Events and Serious Adverse Events in Safety Run-in [ Time Frame: 3 months ]
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.
Dose interruptions/reductions in Safety Run-in [ Time Frame: 3 months ]
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
Dose intensity in Safety Run-in [ Time Frame: 3 months ]
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
Progression-free survival in Randomized part [ Time Frame: 18 months ]
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
Inclution 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.
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
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
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
The Estimated Number of Participants
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Taiwan
20 participants
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Global
156 participants
