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NCT03818542 · ClinicalTrials.gov registry record · Phase 1

A Study to Assess the Effects of Multiple Study Drug Regimens in Subjects With Newly Diagnosed Locally Advanced Head and Neck Squamous Cell Carcinoma

A Phase 1 study, sponsored by AbbVie.

Terminated
Registry status
Phase 1
Development phase
3
Enrollment target

NCT03818542: Clinical Trial Phase 1 study, sponsored by AbbVie.

NCT03818542 is a Phase 1 study that was terminated before completion, run by AbbVie. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03818542, a Phase 1 study, was terminated before completion, sponsored by AbbVie.

TERMINATED
Registry status
Phase 1
Development phase
3 participants
Enrollment target

Study Summary

A study evaluating the safety, pharmacokinetics, and biomarker profiles of multiple study drugs as monotherapy in subjects with newly diagnosed, treatment-naïve locally advanced squamous cell carcinoma of the head and neck who are candidates for surgical resection.

Primary Outcome

The primary biomarker endpoint is to assess immune activation gene changes in the tumor microenvironment associated with T cell infiltration and activation, comparing baseline biopsy to surgical resection following drug treatment.

Interventions

  • DRUG ABBV-927
  • DRUG ABBV-181
  • DRUG ABBV-368

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2020-01-22
Est. Completion 2020-09-23
Phase Phase 1
AbbVie

526 total trials

Why NCT03818542 stopped before completion

NCT03818542 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 3 interventions - of which ABBV-927 is the first listed.

NCT03818542 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03818542 about?

NCT03818542 is a clinical study titled "A Study to Assess the Effects of Multiple Study Drug Regimens in Subjects With Newly Diagnosed Locally Advanced Head and Neck Squamous Cell Carcinoma". A study evaluating the safety, pharmacokinetics, and biomarker profiles of multiple study drugs as monotherapy in subjects with newly diagnosed, treatment-naïve locally advanced squamous cell carcinoma of the head and neck who are candidates for surgical resection.

What is the current status of trial NCT03818542?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2020-01-22. Estimated completion is 2020-09-23.

What interventions are being tested in trial NCT03818542?

The interventions under investigation include: ABBV-927 (DRUG), ABBV-181 (DRUG), ABBV-368 (DRUG).

Who is sponsoring clinical trial NCT03818542?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03818542's enrollment target sits among peer trials

3 1999th of 2000 higher than 1 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 NCT03818542, the US trial registry maintained by the National Library of Medicine. NCT03818542 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.