ClinicalTrials.gov record
Active, not recruiting Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT04590963

Public ClinicalTrials.gov record NCT04590963. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 10, 2026, 4:11 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3 Randomized, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combination With Cetuximab in Participants With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor

Study identification

NCT ID
NCT04590963
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
AstraZeneca
Industry
Enrollment
370 participants

Conditions and interventions

Interventions

  • Cetuximab Drug
  • Monalizumab Drug
  • Placebo Other

Drug · Other

Eligibility (public fields only)

Age range
18 Years to 130 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 1, 2020
Primary completion
May 10, 2022
Completion
Sep 23, 2026
Last update posted
Mar 12, 2026

2020 – 2026

United States locations

U.S. sites
17
U.S. states
13
U.S. cities
16
Facility City State ZIP Site status
Research Site Tucson Arizona 85719
Research Site Chicago Illinois 60612
Research Site Westwood Kansas 66205
Research Site Boston Massachusetts 02215
Research Site Ann Arbor Michigan 48109
Research Site Rochester Minnesota 55905
Research Site St Louis Missouri 63110
Research Site Las Vegas Nevada 89169
Research Site New York New York 10029
Research Site Charlotte North Carolina 28204
Research Site Winston-Salem North Carolina 27103
Research Site Columbus Ohio 43210
Research Site Philadelphia Pennsylvania 19104
Research Site Philadelphia Pennsylvania 19111
Research Site Pittsburgh Pennsylvania 15232
Research Site Dallas Texas 75246
Research Site Houston Texas 77090

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 110 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04590963, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 12, 2026 · Synced May 10, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04590963 live on ClinicalTrials.gov.

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