Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer

Phase 3 Active not recruiting 370 enrolled AstraZeneca Innate Pharma · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start: 2020-10-02
Primary completion: 2022-05-11
Completion: 2026-09-24

Outcome

Missed primary endpoint

registry analysis (superiority test); Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2 vs Placebo Q2W + Cetuximab 400 mg/m^2; p = 0.989; Hazard Ratio (HR) 1.00 (95% CI 0.660 to 1.537); Log Rank NCT04590963 ↗

release “planned futility interim analysis of the Phase 3 INTERLINK-1 study sponsored by AstraZeneca did not meet a pre-defined threshold for efficacy.” innate-pharma.com ↗

Publications

Nowojewski A, Wheal A, Dott W, Ruscica D, Ghiorghiu S, Valastro B. Implementation of the Study Participant Feedback Questionnaire to understand participant experience in a phase 3 oncology clinical trial. BMJ Open. 2025 Oct 28;15(10):e094596. doi: 10.1136/bmjopen-2024-094596.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cetuximab	Monoclonal antibody	250 mg/m2	Intravenous
Subject	Monalizumab	Monoclonal antibody	750 mg	Intravenous