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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.
Must not have
High risk of clinically significant gastrointestinal tract bleeding or any other condition associated with or history of significant bleeding.
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing new drugs (NIS793 and spartalizumab) with standard chemotherapy (gemcitabine/nab-paclitaxel) in patients with advanced pancreatic cancer. The goal is to see if these new drugs can help improve treatment outcomes. The study involves patients who are receiving their first treatment for metastatic pancreatic cancer.
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a type of pancreatic cancer that has not been treated and can be measured.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a high risk of serious bleeding in my stomach or intestines.
Select...
I do not have brain metastases needing urgent treatment or worsening symptoms.
Select...
My pancreatic cancer is MSI-H.
Select...
I have been diagnosed with a specific type of pancreatic tumor.
Select...
I have or had a serious lung condition.
Select...
I have heart problems that affect my daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSecondary study objectives
Antidrug antibodies (ADA) (anti-NIS793 and anti-spartalizumab) expression in Randomized part
CD8 and PD-L1 expression in Randomized part
Dose intensity in Randomized part
+9 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
2017
Completed Phase 3
~850
nab-paclitaxel
2008
Completed Phase 4
~1420
gemcitabine
2013
Completed Phase 3
~4260
NIS793
2019
Completed Phase 3
~680
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for pancreatic cancer include chemotherapy and immunotherapy. Chemotherapy agents like gemcitabine and nab-paclitaxel disrupt DNA replication in cancer cells, causing cell death.
Immunotherapy, such as anti-PD-1 monoclonal antibodies like spartalizumab, boosts the immune system's ability to target and kill cancer cells by blocking the PD-1 pathway, which tumors use to avoid immune detection. Novel agents like NIS793 may target specific pathways critical for tumor growth and spread.
Understanding these mechanisms helps in choosing effective treatments, improving patient outcomes, and managing side effects.
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,899 Previous Clinical Trials
4,207,240 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a type of pancreatic cancer that has not been treated and can be measured.I have a high risk of serious bleeding in my stomach or intestines.I have hepatitis B or C, but it's under control with medication.I do not have brain metastases needing urgent treatment or worsening symptoms.I have conditions that are warned against for gemcitabine and nab-paclitaxel treatment.My pancreatic cancer is MSI-H.You have had serious allergic reactions to any ingredients in the study drug or other similar medications.I am fully active and can carry on all my pre-disease activities without restriction.I have had treatments like surgery or chemotherapy for pancreatic cancer, but not for its metastatic stage.I have been diagnosed with a specific type of pancreatic tumor.I have or had a serious lung condition.I am 18 years old or older.My doctor believes surgery could potentially cure my condition.I am willing and able to have a tumor biopsy as per my treatment center's rules.I have heart problems that affect my daily activities.
Research Study Groups:
This trial has the following groups:- Group 1: Randomized Arm 2
- Group 2: Safety Run-in
- Group 3: Randomized Arm 1
- Group 4: Randomized Arm 3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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