Study of Monalizumab Given With Cetuximab or Placebo Given with Cetuximab in Participants With Head and Neck Cancer that has come back or spread to other parts of the body

Phase 1

• Conditions: Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor; MedDRA version: 21.1Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-004770-25-DE
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-13
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 624

Inclusion Criteria

1. Are aged 18 years and over
2. Recurrent or metastatic SCCHN (oral cavity, oropharynx, hypopharynx, or larynx)
3. Received treatment using a PD-(L)1 inhibitor
4. Prior platinum failure
5. Received 1 or 2 prior systemic regimens for recurrent or metastatic SCCHN
6. At least one measurable lesion at baseline that qualifies RECIST 1.1
7. A fresh or recently acquired tumor tissue for the purpose of biomarker testing
8. WHO/ECOG PS of 0 or 1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 416
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 208

Exclusion Criteria

1. 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
2. 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)
3. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis
4. 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
Secondary Objective: To compare the effect of monalizumab and cetuximab (arm A) relative to placebo and cetuximab (arm B) by: <br>1. assessment of OS in all randomized participants;<br>2. assessment of PFS, ORR, DoR; <br>3. assessment of disease-related symptoms, functioning and quality of life; <br>4. characterization of the association between clinical outcome and protein expression in the tumor;<br>5. assessment of safety and tolerability.<br><br>To investigate PK and immunogenicity of monalizumab.;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 HPV-unrelated participants. ;Primary end point(s): Overall survival, defined as the time from the date of randomization until date of death due to any cause.;Timepoint(s) of evaluation of this end point: Assessments of survival status must be made periodically from enrollment.