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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
Closed
Cancer Type
Pancreatic Cancer
Unknown Primary
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04390763
Protocol IDs
CNIS793B12201 (primary)
NCI-2021-03207
2020-000349-14
Study Sponsor
Novartis Pharmaceuticals Corporation

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.

Eligibility

  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.
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Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.