Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer (INTERLINK-1)

AstraZeneca

Status and phase: Active, not recruiting; Phase 3

Conditions: Squamous Cell Carcinoma of the Head and Neck

Treatments: Drug: Monalizumab; Drug: Cetuximab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04590963

2024-511813-39-00 (Registry Identifier)

D7310C00001

2019-004770-25 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 370 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Are aged 18 years and over
• Recurrent or metastatic squamous cell carcinoma of the SCCHN, oral cavity, oropharynx, hypopharynx, or larynx which has progressed on or after previous systemic cancer therapy and is not amenable to curative therapy
• Received prior treatment using a programmed cell death ligand-1 (PD-L1) inhibitor
• Prior platinum failure
• Received 1 or 2 prior systemic regimens for recurrent or metastatic SCCHN
• Has measurable disease per RECIST 1.1
• A fresh or recently acquired tumor tissue for the purpose of biomarker testing
• World Health Organization (WHO)/ Eastern Cooperative Oncology Group (ECOG) Performance Status 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 locally advanced 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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370 participants in 2 patient groups

Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2

Experimental group

Description:

Participants will receive intravenous (IV) monalizumab 750 mg every two weeks (Q2W) and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 every one week (Q1W) until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.

Treatment:

Drug: Cetuximab

Drug: Monalizumab

Placebo Q2W + Cetuximab 400 mg/m^2

Active Comparator group

Description:

Participants will receieve IV placebo matched to monalizumab Q2W and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.

Treatment:

Other: Placebo

Drug: Cetuximab