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NCT04390763 · ClinicalTrials.gov registry record · Phase 2
Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 164
- Enrollment target
NCT04390763: Clinical Trial Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT04390763 is a Phase 2 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 164 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04390763, a Phase 2 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 164 participants
- Enrollment target
Study 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 previously untreated mPDAC.
Primary Outcome
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 where the relationship to study treatment cannot be ruled out and is not clearly related solely to disease, disease progression, inter-current illness or concomitant medications, which occurs within the DLT evaluation period. The DLT evaluation period is the first 28 days of treatment with NIS793 with spartalizumab in combination with gemc
Interventions
- DRUG nab-paclitaxel
- DRUG gemcitabine
- BIOLOGICAL Spartalizumab
- BIOLOGICAL NIS793
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2020-10-16 |
| Est. Completion | 2024-05-02 |
| Phase | Phase 2 |
Why NCT04390763 stopped before completion
NCT04390763 is an interventional study that assigns participants to a tested intervention. The registered 164 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% higher).
The record links to 0 conditions, and to 4 interventions - of which nab-paclitaxel is the first listed.
NCT04390763 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04390763 about?
NCT04390763 is a clinical study titled "Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)". 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 previously untreated mPDAC.
What is the current status of trial NCT04390763?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 164 participants. The study started on 2020-10-16. Estimated completion is 2024-05-02.
What interventions are being tested in trial NCT04390763?
The interventions under investigation include: nab-paclitaxel (DRUG), gemcitabine (DRUG), Spartalizumab (BIOLOGICAL), NIS793 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04390763?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04390763's enrollment target sits among peer trials
164 413th of 2000 higher than 1,583 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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