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Closed (no longer recruiting)Last updated: 2 February 2024

INTERLINK-1: This phase III trial is comparing the safety and effectiveness of two targeted therapies (monalizumab and cetuximab, compared to placebo and cetuximab) in patients with head and neck cancers that have spread to other parts of the body or have come back after treatmentA Phase 3 Randomized, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combination With Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor

Clinical summary

Summary

Patients 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 randomised in a 2:1 ratio to receive monalizumab and cetuximab or placebo and cetuximab, until progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. All patients will be followed for survival after progression is confirmed.

Conditions

This trial is treating patients with squamous cell carcinoma of the head and neck.

Cancer

Head and Neck Cancers Head and Neck

Age

People18 - 130

Phase

III

Trial Acronym

INTERLINK-1

More information

Trial Identifiers

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Trial sponsor

AstraZeneca

Scientific Title

A Phase 3 Randomized, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combination With Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor

Eligibility

Inclusion

  • 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

  • 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)

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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