Trial · NCT04390763

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

NCT04390763, Phase 2, Terminated, Novartis Pharmaceuticals; results first posted 2025-05-28

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC). Trials, record NCT04390763. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04390763

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

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)
NCT number: NCT04390763
Status: Terminated
Phases: Phase 2
Enrollment: 164 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Metastatic Pancreatic Ductal Adenocarcinoma
Interventions: NIS793, Spartalizumab, gemcitabine, nab-paclitaxel
First posted: 2020-05-18
Last updated: 2025-10-16
Other registries' IDs: eudract:2020-000349-14
Results first posted: 2025-05-28

Source ClinicalTrials.gov

Registered outcomes31

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Safety run-in Part: Number of Participants With Dose-Limiting Toxicities (DLTs)	First cycle of treatment (28 days)	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.
Primary	Safety run-in Part: Number of Participants With AEs and SAEs During the On-treatment Period	Up to approximately 0.8 years	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.
Primary	Safety run-in Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel	Up to approximately 0.7 years	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.
Primary	Safety run-in Part: Dose Intensity of NIS793 and Spartalizumab	Cycle 1 and Cycle 3. The duration of each cycle was 28 days.	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.
Primary	Safety run-in Part: Dose Intensity of Gemcitabine and Nab-paclitaxel	Cycle 1 and Cycle 3. The duration of each cycle was 28 days.	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.
Primary	Randomized Part: Progression-Free Survival (PFS) Per RECIST v1.1 - Bayesian Model	Up to approximately 2 years. Risk changing timepoint=approximately 0.3 years.	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.
Primary	Randomized Part: Progression-Free Survival (PFS) Per RECIST v1.1 - Kaplan-Meier Curves and Cox Model	Up to approximately 2 years	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.
Secondary	Randomized Part: Number of Participants With AEs and SAEs During the On-treatment Period	Up to approximately 1.8 years	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.
Secondary	Randomized Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel	Up to approximately 1.7 years	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.
Secondary	Randomized Part: Dose Intensity of NIS973 and Spartalizumab	Cycle 1 and Cycle 3. The duration of each cycle was 28 days	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.

1 to 10 of 31Source ClinicalTrials.gov

See all 31 registered outcomes

Outcomes32

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Safety run-in Part: Number of Participants With Dose-Limiting Toxicities (DLTs)	First cycle of treatment (28 days)	Dose-Determining Set (DDS) including all participants in the Safety run-in part who met the minimum exposure criterion defined in the protocol and had sufficient safety evaluations after 4 weeks of treatment or experienced a DLT during the first 4 weeks of treatment.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Safety run-in Part: Number of Participants With AEs and SAEs During the On-treatment Period	Up to approximately 0.8 years	Safety set 1	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Safety run-in Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel	Up to approximately 0.7 years	Safety set 1	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Safety run-in Part: Dose Intensity of NIS793 and Spartalizumab	Cycle 1 and Cycle 3. The duration of each cycle was 28 days.	Patients in the Safety set 1 who received NIS793 or spartalizumab at each reported treatment cycle.	mg per cycle	MEAN
PRIMARY	Safety run-in Part: Dose Intensity of Gemcitabine and Nab-paclitaxel	Cycle 1 and Cycle 3. The duration of each cycle was 28 days.	Patients in the Safety set 1 who received gemcitabine or nab-paclitaxel at each reported treatment cycle.	mg per m^2 per cycle	MEAN
PRIMARY	Randomized Part: Progression-Free Survival (PFS) Per RECIST v1.1 - Bayesian Model	Up to approximately 2 years. Risk changing timepoint=approximately 0.3 years.	Full Analysis Set (FAS)	events (progression, death) per year	MEDIAN
PRIMARY	Randomized Part: Progression-Free Survival (PFS) Per RECIST v1.1 - Kaplan-Meier Curves and Cox Model	Up to approximately 2 years	Full Analysis Set (FAS)	months	MEDIAN
SECONDARY	Randomized Part: Number of Participants With AEs and SAEs During the On-treatment Period	Up to approximately 1.8 years	Safety set 2	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Randomized Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel	Up to approximately 1.7 years	Safety set 2	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Randomized Part: Dose Intensity of NIS973 and Spartalizumab	Cycle 1 and Cycle 3. The duration of each cycle was 28 days	Patients in the Safety set 2 who received NIS793 or spartalizumab at each reported treatment cycle.	mg per cycle	MEAN

1 to 10 of 32Source ClinicalTrials.gov

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Results by group203

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Safety run-in Part: Number of Participants With Dose-Limiting Toxicities (DLTs)	Run-in: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel	Any DLT	1	Participants
Safety run-in Part: Number of Participants With Dose-Limiting Toxicities (DLTs)	Run-in: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel	Colitis	1	Participants
Safety run-in Part: Number of Participants With AEs and SAEs During the On-treatment Period	Run-in: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel	AEs	11	Participants
Safety run-in Part: Number of Participants With AEs and SAEs During the On-treatment Period	Run-in: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel	Treatment-related AEs	11	Participants
Safety run-in Part: Number of Participants With AEs and SAEs During the On-treatment Period	Run-in: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel	AEs with grade>=3	11	Participants
Safety run-in Part: Number of Participants With AEs and SAEs During the On-treatment Period	Run-in: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel	Treatment-related AEs with grade>=3	8	Participants
Safety run-in Part: Number of Participants With AEs and SAEs During the On-treatment Period	Run-in: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel	SAEs	8	Participants
Safety run-in Part: Number of Participants With AEs and SAEs During the On-treatment Period	Run-in: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel	Treatment-related SAEs	3	Participants
Safety run-in Part: Number of Participants With AEs and SAEs During the On-treatment Period	Run-in: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel	Fatal SAEs	1	Participants
Safety run-in Part: Number of Participants With AEs and SAEs During the On-treatment Period	Run-in: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel	Treatment-related fatal SAEs	0	Participants

1 to 10 of 203Source ClinicalTrials.gov

See all 203 results by group

Participant flow36

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Safety run-in Part	STARTED	Run-in: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel	11
Safety run-in Part	STARTED	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel	0
Safety run-in Part	STARTED	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel	0
Safety run-in Part	STARTED	Arm 3: Gemcitabine/Nab-paclitaxel	0
Safety run-in Part	Safety Set 1	Run-in: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel	11
Safety run-in Part	Safety Set 1	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel	0
Safety run-in Part	Safety Set 1	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel	0
Safety run-in Part	Safety Set 1	Arm 3: Gemcitabine/Nab-paclitaxel	0
Safety run-in Part	COMPLETED	Run-in: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel	0
Safety run-in Part	COMPLETED	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel	0

1 to 10 of 36Source ClinicalTrials.gov

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Adverse events2,115

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Run-in: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel_On- and Post-treatment	5	11
other	Anaemia	Blood and lymphatic system disorders	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel_On- and Post-treatment	29	46
other	Anaemia	Blood and lymphatic system disorders	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel_On- and Post-treatment	33	49
other	Anaemia	Blood and lymphatic system disorders	Arm 3: Gemcitabine/Nab-paclitaxel_On- and Post-treatment	20	45
other	Anaemia	Blood and lymphatic system disorders	All Participants_On- and Post-treatment	87	151
other	Anaemia	Blood and lymphatic system disorders	Run-in: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel_Survival Period		0
other	Anaemia	Blood and lymphatic system disorders	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel_Survival Period		0
other	Anaemia	Blood and lymphatic system disorders	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel_Survival Period		0
other	Anaemia	Blood and lymphatic system disorders	Arm 3: Gemcitabine/Nab-paclitaxel_Survival Period		0
other	Leukocytosis	Blood and lymphatic system disorders	Run-in: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel_On- and Post-treatment	1	11

1 to 10 of 2,115Source ClinicalTrials.gov

See all 2,115 adverse events

Adverse event totals27

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Run-in: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel_On- and Post-treatment	5	11
Total, all-cause mortality	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel_On- and Post-treatment	18	50
Total, all-cause mortality	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel_On- and Post-treatment	19	51
Total, all-cause mortality	Arm 3: Gemcitabine/Nab-paclitaxel_On- and Post-treatment	4	52
Total, all-cause mortality	All Participants_On- and Post-treatment	46	164
Total, all-cause mortality	Run-in: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel_Survival Period	5	6
Total, all-cause mortality	Arm 1: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel_Survival Period	15	28
Total, all-cause mortality	Arm 2: NIS793 + Gemcitabine/Nab-paclitaxel_Survival Period	22	30
Total, all-cause mortality	Arm 3: Gemcitabine/Nab-paclitaxel_Survival Period	35	41
Total, other adverse events	Run-in: NIS793 + Spartalizumab + Gemcitabine/Nab-paclitaxel_On- and Post-treatment	11	11

1 to 10 of 27Source ClinicalTrials.gov

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Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04390763

GET https://conductscience.org/api/trials/v1/NCT04390763/registered?page=2

API reference For AI assistants