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

Recruiting in Palo Alto (17 mi)

+33 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Novartis Pharmaceuticals

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

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.

Inclusion Criteria

I have a type of pancreatic cancer that has not been treated and can be measured.

I am fully active and can carry on all my pre-disease activities without restriction.

Signed informed consent must be obtained prior to participation in the study.

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Exclusion Criteria

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.

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Treatment Details

Interventions

gemcitabine (Anti-metabolites)
nab-paclitaxel (Anti-tumor antibiotic)
NIS793 (Monoclonal Antibodies)
Spartalizumab (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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