Trials / Active Not Recruiting
Active Not RecruitingNCT04590963
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 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
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 370 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 130 Years
- Healthy volunteers
- Not accepted
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
Detailed description
Participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) who had prior immune checkpoint inhibitor and platinum-based chemotherapy treatment will be randomized in a 2:1 ratio to monalizumab and cetuximab or placebo and cetuximab. Efficacy and safety assessments will be performed periodically from the time of enrollment and throughout the study. Participants in all arms will continue therapy until progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. All Participants will be followed for survival after progression is confirmed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-10-02
- Primary completion
- 2022-05-11
- Completion
- 2026-09-24
- First posted
- 2020-10-19
- Last updated
- 2026-03-13
- Results posted
- 2023-11-18
Locations
127 sites across 23 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
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04590963. Inclusion in this directory is not an endorsement.