What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as gemcitabine and nab-paclitaxel, are associated with side effects including neutropenia, fatigue, neuropathy, and gastrointestinal issues like nausea and diarrhea. Anti-PD-1 monoclonal antibodies, such as spartalizumab, can cause immune-related adverse events, including pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. These side effects vary in severity and frequency, and patients should discuss them with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer that involve targeted therapies and immune checkpoint inhibitors. For instance, pembrolizumab (Keytruda), an anti-PD-1 monoclonal antibody, has been approved for tumors with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR), which can include pancreatic cancer. Additionally, olaparib (Lynparza), a PARP inhibitor, has been approved for maintenance treatment in patients with germline BRCA-mutated metastatic pancreatic cancer. These approvals highlight the FDA's recognition of targeted and immunotherapy approaches in treating pancreatic cancer.

What other types of research exist?

Promising novel alternatives for pancreatic cancer treatment in 2024 include: 1) Sunitinib, which has shown efficacy in Japanese patients with unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumors, demonstrating a median progression-free survival of 16.8 months. 2) Pembrolizumab, an anti-PD-1 monoclonal antibody, which has shown activity in various cancers and could be considered for pancreatic cancer based on its mechanism of action and ongoing research. 3) Combination therapies involving CDK4 inhibitors like abemaciclib, which are being explored in other cancers and may offer potential benefits in pancreatic cancer. These alternatives should be discussed with a healthcare provider to determine the best treatment plan.

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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

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a high risk of serious bleeding in my stomach or intestines.

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I do not have brain metastases needing urgent treatment or worsening symptoms.

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My pancreatic cancer is MSI-H.

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I have been diagnosed with a specific type of pancreatic tumor.

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I have or had a serious lung condition.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

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 more

Secondary 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 more

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

~1430

gemcitabine

2013

Completed Phase 3

~4260

NIS793

2017

Completed Phase 1

~120

0 / 8Eligibility criteria met

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.