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NCT04590963 · MORE INFO

Limitations, agreements, and source contact

Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer · Source last updated 2026-09-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

certain Agreement
other Details
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
pi Sponsor Employee
false
restriction Type
OTHER
restrictive Agreement
true
limitations And Caveats
description
Study enrolment was discontinued after the planned initial interim futility analysis (IA1) due to unlikelihood of achieving statistical significance for OS in the primary endpoint (HPV-unrelated). Therefore, symptoms, function, health-related quality of life (HRQoL), European Organization for Research and Treatment of Cancer (EORTC) scale/item score, pharmacokinetic (PK) parameters, immunogenicity, human leukocyte antigen E (HLA-E), and NKp46+ expression outcomes were not evaluated.
point Of Contact
email
information.center@astrazeneca.com
organization
AstraZeneca Clinical Study Information Center
phone
1-877-240-9479
title
Global Clinical Lead
Complete source fields
certain Agreement
other Details
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
pi Sponsor Employee
false
restriction Type
OTHER
restrictive Agreement
true
limitations And Caveats
description
Study enrolment was discontinued after the planned initial interim futility analysis (IA1) due to unlikelihood of achieving statistical significance for OS in the primary endpoint (HPV-unrelated). Therefore, symptoms, function, health-related quality of life (HRQoL), European Organization for Research and Treatment of Cancer (EORTC) scale/item score, pharmacokinetic (PK) parameters, immunogenicity, human leukocyte antigen E (HLA-E), and NKp46+ expression outcomes were not evaluated.
point Of Contact
email
information.center@astrazeneca.com
organization
AstraZeneca Clinical Study Information Center
phone
1-877-240-9479
title
Global Clinical Lead

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice