Monalizumab + Cetuximab for Head and Neck Cancer

(INTERLINK-1 Trial)

Recruiting in Palo Alto (17 mi)

+139 other locations

Overseen by Jérôme Fayette, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Roger B Cohen, MD

Principal Investigator

Abramson Cancer Center, Perelman Center for Advanced Medicine

Jérôme Fayette, MD, PhD

Principal Investigator

Centre Leon Berard

Dario Ruscica, MD

Principal Investigator

AstraZeneca, Cambridge, UK

Eligibility Criteria

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.

Inclusion Criteria

I am fully active or able to carry out light work.

My cancer has returned or spread and cannot be cured with treatment.

Has measurable disease per RECIST 1.1

Exclusion Criteria

I am not on any cancer treatments, except hormone therapy for other conditions.

My cancer is in the head or neck but not specified in the study details.

I had cetuximab for early-stage cancer without worsening for 6 months.

Treatment Details

Interventions

• Cetuximab (Monoclonal Antibodies)
• Monalizumab (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2 Experimental Treatment 2 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^2 Active Control 2 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.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Innate Pharma

Industry Sponsor

Trials

29

Recruited

3,100+