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

Active:	No
Cancer Type:	Pancreatic Cancer Unknown Primary	NCT ID:	NCT04390763
Trial Phases:	Phase II	Protocol IDs:	CNIS793B12201 (primary) NCI-2021-03207 2020-000349-14
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Novartis Pharmaceuticals Corporation
NCI Full Details:	http://clinicaltrials.gov/show/NCT04390763

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

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