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

NCT04590963 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2026-03-13

Study results available
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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

  • Squamous Cell Carcinoma of the Head and Neck

Interventions

DRUG

Monalizumab

Participants will receive IV infusion of monalizumab as stated in arm description.

DRUG

Cetuximab

Participants will receive IV infusion of cetuximab as stated in arm description.

OTHER

Placebo

Participants will receive IV infusion of placebo as stated in arm description.

Sponsors & Collaborators

  • Innate Pharma

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Roger B Cohen, MD · Abramson Cancer Center, Perelman Center for Advanced Medicine

  • Jérôme Fayette, MD · Centre Leon Berard

  • Dario Ruscica, MD · AstraZeneca, Cambridge, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-02
Primary Completion
2022-05-11
Completion
2026-09-24
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • France
  • Germany
  • Greece
  • Italy
  • Japan
  • Netherlands
  • Philippines
  • Poland
  • Portugal
  • Russia
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04590963 on ClinicalTrials.gov