Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
Pancreatic Cancer
Unknown Primary
18 Years and older, Male and Female
CNIS793B12201 (primary)
NCI-2021-03207
2020-000349-14
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.
Objectives
This is a randomized, parallel arms, open-label, multi-center, Phase II study to evaluate
the efficacy and safety of NIS793 with and without spartalizumab in combination with
gemcitabine/nab-paclitaxel in participants with first-line metastatic pancreatic ductal
adenocarcinoma (mPDAC).
The study started with a Safety Run-in to assess the safety and tolerability of NIS793 in
combination with spartalizumab and standard of care (SOC) gemcitabine/nab-paclitaxel.
Doses defined for each study treatment, as part of this quadruplet were administered in
the Randomized part in the quadruplet/triplet/doublet-based treatment arms.
The Randomized part opened after the Safety Run-in had completed. Participants were
randomized in a 1:1:1 ratio to one of the three treatment arms:
- Arm 1: NIS793 with spartalizumab and gemcitabine/nab-paclitaxel
- Arm 2: NIS793 with gemcitabine/nab-paclitaxel
- Arm 3: gemcitabine/nab-paclitaxel
Eligibility
- Signed informed consent must be obtained prior to participation in the study.
- Male or female = 18 years of age at the time of informed consent.
- Participants with histologically or cytologically confirmed treatment-naïve metastatic adenocarcinoma of the pancreas with measurable disease as per RECIST 1.1.
- 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.
- ECOG performance status = 1.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
Click here to learn more about clinical trials.