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

Phase 1

Conditions: MedDRA version: 21.1Level: PTClassification code: 10067821Term: Head and neck cancer Class: 100000004864
Therapeutic area: Diseases [C] - Neoplasms [C04]
Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor

Registration Number: CTIS2024-511813-39-00

Lead Sponsor: AstraZeneca AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 244

Inclusion Criteria

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

Exclusion Criteria

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, 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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: To compare the effect of monalizumab and cetuximab (arm A) relative to placebo and cetuximab (arm B) by: 1. assessment of OS in all randomized participants; 2. assessment of PFS, ORR, DoR 3. assessment of disease-related symptoms, functioning and quality of life 4. characterization of the association between clinical outcome and protein expression in the tumor 5. assessment of safety and tolerability., To investigate PK and immunogenicity of monalizumab;Primary end point(s): Overall survival, defined as the time from the date of randomization until date of death due to any cause.

Secondary Outcome Measures