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

Source: https://onco.cc/trials/nct04590963/  
OnCo record `nct04590963` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial testing Monalizumab in head and neck squamous cell carcinoma, active and no longer recruiting.

## Summary

Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer is a phase 3 interventional study registered as NCT04590963, led by AstraZeneca with Innate Pharma, and active but no longer recruiting on the registry. Official title: A Phase 3 Randomised, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combination With Cetuximab in Participants With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor. Planned enrolment is 370 participants (actual). The study started in 2020-10-02 and primary completion is expected in 2022-05-11. Results have been posted on ClinicalTrials.gov; they are not yet summarised here.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-22
- Also known as: INTERLINK-1
- Tags: ctgov-ingest
- Registry id: NCT04590963
- Phase: 3
- Setting: A Phase 3 Randomized, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combination With Cetuximab in Participants With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor
- Sponsor: AstraZeneca
- Enrolled: 370
- Outcomes: Overall Survival (OS) in Human Papillomavirus (HPV)-Unrelated Analysis Set: Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2 8.8 months vs Placebo Q2W + Cetuximab 400 mg/m^2 8.6 months, HR 1; Percentage of Participants With Objective Response (OR) Per RECIST 1.1 in HPV-unrelated Analysis Set: Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2 15.2% vs Placebo Q2W + Cetuximab 400 mg/m^2 23.9%

## Sources

- ClinicalTrials.gov NCT04590963: https://clinicaltrials.gov/study/NCT04590963

## Connected records

- cancers: [Head and neck squamous cell carcinoma](https://onco.cc/cancers/head-and-neck/), [Recurrent or metastatic head and neck squamous cell carcinoma](https://onco.cc/cancers/recurrent-metastatic-hnscc/)
- drugs: [Monalizumab](https://onco.cc/drugs/monalizumab/)
- companies: [AstraZeneca](https://onco.cc/companies/astrazeneca/)

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