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Monoclonal Antibodies

Monalizumab + Cetuximab for Head and Neck Cancer (INTERLINK-1 Trial)

Phase 3

Waitlist Available

Led By Roger B Cohen, MD

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (-28 to -1) through 17.5 months (maximum observed duration)

Awards & highlights

Pivotal Trial

Summary

This trial will test if two drugs are more effective than one drug in treating head and neck cancer.

Who is the study for?

This trial is for adults over 18 with recurrent or metastatic head and neck cancer who have had prior treatments fail, including a PD-(L)1 inhibitor. They should not have used cetuximab unless it was part of curative therapy without progression for at least 6 months. Participants must be in good physical condition (WHO/ECOG status of 0 or 1) and cannot have autoimmune or inflammatory disorders.

What is being tested?

The study compares the effectiveness and safety of Monalizumab plus Cetuximab against a placebo combined with Cetuximab in patients with advanced head and neck cancer. It's randomized, meaning participants are randomly assigned to groups, double-blind so neither researchers nor participants know who gets which treatment, and conducted globally across multiple centers.

What are the potential side effects?

Potential side effects may include allergic reactions to medication components, skin rash due to Cetuximab, fatigue, nausea, as well as increased risk of infections from immune system suppression by Monalizumab.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (-28 to -1) through 17.5 months (maximum observed duration)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (-28 to -1) through 17.5 months (maximum observed duration)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (-28 to -1) through 17.5 months (maximum observed duration) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS) in Human Papillomavirus (HPV)-Unrelated Analysis Set

Secondary study objectives

Duration of Response (DoR) Per RECIST 1.1 in HPV-unrelated Analysis Set

Duration of Response Per RECIST 1.1 in FAS

Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs

+8 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2Experimental Treatment2 Interventions

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.

Group II: Placebo Q2W + Cetuximab 400 mg/m^2Active Control2 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Cetuximab

2011

Completed Phase 3

~2480

Monalizumab

2019

Completed Phase 2

~260