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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: Active Phase 3 study of Squamous Cell Carcinoma of the Head and Neck, sponsored by AstraZeneca.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The OS is defined as time from the date of randomization until death due to any cause regardless of whether the participant withdraws from randomized therapy or receives another anti-cancer therapy (i.e. date of death or censoring - date of randomization + 1). The OS was analyzed using Kaplan-Meier technique. Statistical analysis was performed using P-value from a stratified log-rank test and hazard ratio (HR) and confidence intervals (CIs) from a stratified Cox proportional hazards model. Analy
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 370 participants |
| Start Date | 2020-10-02 |
| Est. Completion | 2026-09-24 |
| Phase | Phase 3 |
What the registry record for NCT04590963 still lists
NCT04590963 is an interventional study that assigns participants to a tested intervention. The registered 370 participants enrollment target is mid-sized for trials with a published cap, 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 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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
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Where NCT04590963's enrollment target sits among peer trials
370 4th of 29 higher than 26 of 29 other Squamous Cell Carcinoma of the Head and Neck trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Squamous Cell Carcinoma of the Head and Neck 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.
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