TerminatedPhase 2

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

Stopped: The study was early terminated following the NIS793 treatment halt and urgent safety measure issued in July 2023, as the continued evaluation of Standard of Care alone will not support the original purpose of this phase 2 clinical trial.

United States, Australia, Austria164 participantsStarted 2020-10-16

Plain-language 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 previously untreated mPDAC.

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety run-in Part: Number of Participants With Dose-Limiting Toxicities (DLTs)

Timeframe: First cycle of treatment (28 days)

Safety run-in Part: Number of Participants With AEs and SAEs During the On-treatment Period

Timeframe: 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

Timeframe: Up to approximately 0.7 years

Safety run-in Part: Dose Intensity of NIS793 and Spartalizumab

Timeframe: Cycle 1 and Cycle 3. The duration of each cycle was 28 days.

Safety run-in Part: Dose Intensity of Gemcitabine and Nab-paclitaxel

Timeframe: 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

Timeframe: Up to approximately 2 years. Risk changing timepoint=approximately 0.3 years.

Trial details

NCT IDNCT04390763

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-26

Results submitted2025-03-04

View on ClinicalTrials.gov More Metastatic Pancreatic Ductal Adenocarcinoma trials

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

United States, Australia, Austria164 participantsStarted 2020-10-16

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Exclusion criteria

What they're measuring

Safety run-in Part: Number of Participants With Dose-Limiting Toxicities (DLTs)

Timeframe: First cycle of treatment (28 days)

Safety run-in Part: Number of Participants With AEs and SAEs During the On-treatment Period

Timeframe: 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

Timeframe: Up to approximately 0.7 years

Safety run-in Part: Dose Intensity of NIS793 and Spartalizumab

Timeframe: Cycle 1 and Cycle 3. The duration of each cycle was 28 days.

Safety run-in Part: Dose Intensity of Gemcitabine and Nab-paclitaxel

Timeframe: 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

Timeframe: Up to approximately 2 years. Risk changing timepoint=approximately 0.3 years.