Overview

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

Status:
Recruiting
Trial end date:
2023-05-08
Target enrollment:
0
Participant gender:
All
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 untreated mPDAC.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Gemcitabine
Paclitaxel
Spartalizumab
Criteria
Inclusion Criteria:

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

2. Male or female ≥ 18 years of age at the time of informed consent.

3. Participants with histologically or cytologically confirmed treatment-naïve metastatic
adenocarcinoma of the pancreas with measurable disease as per RECIST 1.1.

4. 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.

5. ECOG performance status ≤ 1.

Exclusion Criteria:

1. Previous radiotherapy, surgery (with exception of placement of biliary stent, which is
allowed), chemotherapy or any other investigational therapy for the treatment of
metastatic pancreatic cancer. Participants having received previous chemotherapy in
the adjuvant setting.

2. Participants amenable to potentially curative resection.

3. Participants with a diagnosis of pancreatic neuroendocrine tumors (NETs), acinar, or
islet cell tumors.

4. Having out of range laboratory values as pre-defined in the protocol.

5. Participants with MSI-H pancreatic adenocarcinoma.

6. 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.

7. History of severe hypersensitivity reactions to any ingredient of study drug(s) and
other mAbs and/or their excipients.

8. The participant exhibits any of the events outlined in the contra-indications or
special warnings and precautions sections of gemcitabine and nab-paclitaxel as per
locally approved labels.

9. Impaired cardiac function or clinically significant cardiac disease.

10. Known history of testing positive HIV infection.

11. Active HBV or HCV infection. Participants whose disease is controlled under antiviral
therapy should not be excluded.

12. History of or current interstitial lung disease or pneumonitis grade ≥ 2

13. High risk of clinically significant gastrointestinal tract bleeding or any other
condition associated with or history of significant bleeding.

Other protocol-defined inclusion/exclusion criteria may apply