Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 3

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

NCT04590963 · View on ClinicalTrials.gov ↗

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

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

1,053 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04590963

The ClinicalTrials.gov registry entry for NCT04590963 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 370 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,053 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04590963 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Pennsylvania, Other, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04590963?

The interventions under investigation include: Placebo (OTHER), Cetuximab (DRUG), Monalizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04590963?

This trial is sponsored by AstraZeneca, which has 1,053 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial