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Anti-metabolites

NIS793 +/− Spartalizumab + Chemotherapy for Pancreatic Cancer (daNIS-1 Trial)

Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with histologically or cytologically confirmed treatment-naïve metastatic adenocarcinoma of the pancreas with measurable disease as per RECIST 1.1.
ECOG performance status ≤ 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

daNIS-1 Trial Summary

This trial is testing a new combination of drugs to treat pancreatic cancer. The goal is to see if it is more effective and has fewer side effects than the current standard of care.

Who is the study for?
This trial is for adults over 18 with untreated metastatic pancreatic adenocarcinoma, who can undergo a tumor biopsy and have an ECOG performance status ≤ 1. It's not for those with symptomatic brain metastases, severe drug allergies, potential for curative surgery, certain other cancers or infections (HIV, HBV/HCV), significant bleeding risks or heart issues.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of NIS793 with/without Spartalizumab plus standard chemotherapy (gemcitabine/nab-paclitaxel) in first-line treatment of mPDAC. Patients are compared to those receiving only gemcitabine/nab-paclitaxel to see if adding NIS793 improves outcomes.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions from the drugs being administered into the bloodstream, fatigue, digestive problems like nausea and diarrhea, blood cell count changes leading to increased infection risk or bleeding.

daNIS-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a type of pancreatic cancer that has not been treated and can be measured.
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I am fully active and can carry on all my pre-disease activities without restriction.

daNIS-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose intensity in Safety Run-in
Dose interruptions/reductions in Safety Run-in
Incidence and severity of treatment emergent Adverse Events and Serious Adverse Events in Safety Run-in
+2 more
Secondary outcome measures
Antidrug antibodies (ADA) (anti-NIS793 and anti-spartalizumab) expression in Randomized part
CD8 and PD-L1 expression in Randomized part
Duration of response per RECIST 1.1 in Randomized part
+7 more

daNIS-1 Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Safety Run-inExperimental Treatment4 Interventions
Combination of NIS793 + spartalizumab + gemcitabine + nab-paclitaxel
Group II: Randomized Arm 2Experimental Treatment3 Interventions
Combination of NIS793 + gemcitabine + nab-paclitaxel
Group III: Randomized Arm 1Experimental Treatment4 Interventions
Combination of NIS793 + spartalizumab + gemcitabine + nab-paclitaxel
Group IV: Randomized Arm 3Active Control2 Interventions
gemcitabine + nab-paclitaxel
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spartalizumab
2020
Completed Phase 2
~280
nab-paclitaxel
2008
Completed Phase 4
~1330
gemcitabine
2013
Completed Phase 3
~3530
NIS793
2017
Completed Phase 1
~120

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,202 Total Patients Enrolled

Media Library

gemcitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04390763 — Phase 2
Pancreatic Cancer Research Study Groups: Randomized Arm 2, Safety Run-in, Randomized Arm 1, Randomized Arm 3
Pancreatic Cancer Clinical Trial 2023: gemcitabine Highlights & Side Effects. Trial Name: NCT04390763 — Phase 2
gemcitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04390763 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can people with the specified illness participate in this trial at this time?

"That is correct, the online information does show that the trial is still recruiting individuals. This research was first put up on October 16th 2020 and has had one update since then on November 11th 2022. A total of 161 people are needed for this experiment from 5 different locations."

Answered by AI

How many different hospitals are conducting this trial?

"The primary locations for this study are Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Med in Baltimore, Maryland, Emory University School of Medicine/Winship Cancer Institute in Atlanta, Georgia, and University of Pittsburgh Cancer Institute HIllman Cancer Center in Pittsburgh, Pennsylvania. There are also 5 other sites."

Answered by AI

What is the FDA's opinion of NIS793?

"NIS793's safety is estimated to be a 2. While there is some data suggesting it is safe, none of the evidence collected thus far supports its efficacy."

Answered by AI

What are the benefits of NIS793?

"NIS793 is a medication that can help to stop the spread of cancerous cells and growths. It is also used to treat multiple other conditions, like locally advanced non-small cell lung cancer, metastatic bladder cancer, and urinary bladder."

Answered by AI

What is the purpose of this clinical trial?

"The aim of this study is to track progression-free survival over the course of 8 months. Secondary outcomes that will be monitored include the pharmacokinetic parameters AUClast and Cmax, as well as incidence and severity of adverse events and serious adverse events."

Answered by AI

Is NIS793 a new drug being trialed?

"At the moment, there are 1189 ongoing studies involving NIS793. Of those, 331 are in Phase 3 clinical trials. Although most of the studies for NIS793 are based in Shanghai, China, there are 60306 locations worldwide running trials for this treatment."

Answered by AI

How many individuals are being treated as part of this clinical research?

"That is correct. The listing on clinicaltrials.gov says that this trial posted on October 16th, 2020 and last updated November 11th, 2020 is actively recruiting patients. There are 161 patients needed to be recruited from 5 different locations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
2020. "Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04390763.
~34 spots leftby Apr 2025
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