NCT04590963CompletedPhase 3
Study of Monalizumab Given With Cetuximab or Placebo Given with Cetuximab in Patients With Head and Neck Cancer that has come back or spread to other parts of the body
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 13 Nov 2024
Brief summary (registry, in English)
To compare the effect of monalizumab and cetuximab (Arm A) relative to placebo and cetuximab (Arm B) in terms of overall survival (OS) in HPVunrelated participants.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 14 Jun 2024
- Start date
- 4 Mar 2021
- Lead sponsor
- AstraZeneca AB
- Diseases
- Head and neck cancer
- NCT number
- NCT04590963
- EU CT number
- 2024-511813-39-00
- EudraCT number
- 2019-004770-25
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 16
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Had prior cetuximab therapy (unless it was administered in curative LA setting with radiotherapy and no disease progression for at least 6 months following the last cetuximab dose)
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis
- Any concurrent anticancer treatment, except for hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy)
Other illness
- Head and neck cancer of any primary anatomic location in the head and neck not specified in the inclusion criteria, including participants with SCCHN of unknown primary or non-squamous histologies
Who the study is looking for
- Are aged 18 years and over
- Recurrent or metastatic SCCHN (oral cavity, oropharynx, hypopharynx, or larynx)
- Received treatment using a PD-(L)1 inhibitor
- Prior platinum failure
- Received 1 or 2 prior systemic regimens for recurrent or metastatic SCCHN
- At least one measurable lesion at baseline that qualifies RECIST 1.1
- A fresh or recently acquired tumor tissue for the purpose of biomarker testing
- WHO/ECOG PS of 0 or 1
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaet Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Completed |
| Universitaetsklinikum Wuerzburg AöR Coordinator of this site? Confirm its status | Wuerzburg | Germany | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.