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NCT04590963 · ClinicalTrials.gov registry record · Phase 3

Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer

A Phase 3 study of Squamous Cell Carcinoma of the Head and Neck, sponsored by AstraZeneca.

Active
Registry status
Phase 3
Development phase
370
Enrollment target
20
Study locations

NCT04590963 is a Phase 3 study of Squamous Cell Carcinoma of the Head and Neck that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 370 participants, above the 133-participant average among 29 other Squamous Cell Carcinoma of the Head and Neck trials with a reported enrollment target (178% higher). The trial reports 20 study locations across 14 states.

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The verdict

NCT04590963, a Phase 3 study of Squamous Cell Carcinoma of the Head and Neck, is active but no longer recruiting, sponsored by AstraZeneca.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
370 participants
Enrollment target
20
Study locations

Study Summary

This is a randomized, double-blind, multicenter, global Phase 3 study to assess the efficacy and safety of monalizumab and cetuximab, compared to placebo and cetuximab, in Participants with recurrent or metastatic head and neck cancer

Conditions Studied

Squamous Cell Carcinoma of the Head and Neck

Interventions

  • OTHER Placebo
  • DRUG Cetuximab
  • DRUG Monalizumab

Study Locations (20)

Pennsylvania

  • Research Site - Philadelphia
  • Research Site - Philadelphia
  • Research Site - Pittsburgh

Other

  • Research Site - CABA
  • Research Site - CABA
  • Research Site - CABA

North Carolina

  • Research Site - Charlotte
  • Research Site - Winston-Salem

Texas

  • Research Site - Dallas
  • Research Site - Houston

Arizona

  • Research Site - Tucson

Illinois

  • Research Site - Chicago

Kansas

  • Research Site - Westwood

Massachusetts

  • Research Site - Boston

Trial Details

FieldValue
Enrollment Target 370 participants
Start Date 2020-10-02
Est. Completion 2026-09-24
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

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What the Registry Record Tells You About NCT04590963

The ClinicalTrials.gov registry entry for NCT04590963 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 370 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 133-participant average among 29 other Squamous Cell Carcinoma of the Head and Neck trials with a reported enrollment target (178% higher). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Squamous Cell Carcinoma of the Head and Neck appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT04590963 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Pennsylvania, Other, North Carolina.

Frequently Asked Questions

What is clinical trial NCT04590963 about?

NCT04590963 is a clinical study titled "Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer". This is a randomized, double-blind, multicenter, global Phase 3 study to assess the efficacy and safety of monalizumab and cetuximab, compared to placebo and cetuximab, in Participants with recurrent or metastatic head and neck cancer

What is the current status of trial NCT04590963?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 370 participants. The study started on 2020-10-02. Estimated completion is 2026-09-24.

What conditions does trial NCT04590963 study?

This clinical trial studies the following conditions: Squamous Cell Carcinoma of the Head and Neck.

What interventions are being tested in trial NCT04590963?

The interventions under investigation include: Placebo (OTHER), Cetuximab (DRUG), Monalizumab (DRUG).

Who is sponsoring clinical trial NCT04590963?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04590963 being conducted?

This trial has 20 study locations across Arizona, Illinois, Kansas, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.