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NCT03549000 · ClinicalTrials.gov registry record · Phase 1

A Phase I/Ib Study of NZV930 Alone and in Combination With PDR001 and /or NIR178 in Patients With Advanced Malignancies.

A Phase 1 study, sponsored by Novartis Pharmaceuticals.

Terminated
Registry status
Phase 1
Development phase
127
Enrollment target

NCT03549000: Clinical Trial Phase 1 study, sponsored by Novartis Pharmaceuticals.

NCT03549000 is a Phase 1 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 127 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (112% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03549000, a Phase 1 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.

TERMINATED
Registry status
Phase 1
Development phase
127 participants
Enrollment target

Study Summary

The purpose of this study was to assess the safety, tolerability, and preliminary anti-tumor activity of experimental medication NZV930 alone and when combined with PDR001 and/or NIR178, in patients with advanced cancers

Primary Outcome

Incidence and severity of AEs and SAEs, incl. changes in laboratory parameters, vital signs, and ECGs Dose limiting toxicity in cycle 1 (28 days) for single agent NZV930 and NZV930 in combination with PDR001 and/or NIR178 during dose escalation phase only Tolerability: dose interruptions Tolerability: dose reductions Tolerability: dose intensity

Interventions

  • DRUG NIR178
  • OTHER NZV930
  • OTHER PDR001

Trial Details

FieldValue
Enrollment Target 127 participants
Start Date 2018-07-18
Est. Completion 2022-10-17
Phase Phase 1
Novartis Pharmaceuticals

1,375 total trials

Why NCT03549000 stopped before completion

NCT03549000 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (112% higher).

The record links to 0 conditions, and to 3 interventions - of which NIR178 is the first listed.

NCT03549000 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03549000 about?

NCT03549000 is a clinical study titled "A Phase I/Ib Study of NZV930 Alone and in Combination With PDR001 and /or NIR178 in Patients With Advanced Malignancies.". The purpose of this study was to assess the safety, tolerability, and preliminary anti-tumor activity of experimental medication NZV930 alone and when combined with PDR001 and/or NIR178, in patients with advanced cancers

What is the current status of trial NCT03549000?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 127 participants. The study started on 2018-07-18. Estimated completion is 2022-10-17.

What interventions are being tested in trial NCT03549000?

The interventions under investigation include: NIR178 (DRUG), NZV930 (OTHER), PDR001 (OTHER).

Who is sponsoring clinical trial NCT03549000?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03549000's enrollment target sits among peer trials

127 459th of 2000 higher than 1,540 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT03549000, the US trial registry maintained by the National Library of Medicine. NCT03549000 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.