Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer - INTERLINK-1
Study identifier:D7310C00001
ClinicalTrials.gov identifier:NCT04590963
EudraCT identifier:2019-004770-25
CTIS identifier:N/A
Recruitment Complete
Official Title
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
Medical condition
Squamous cell carcinoma of the head and neck
Phase
Phase 3
Healthy volunteers
No
Study drug
Monalizumab, Cetuximab
Sex
All
Actual Enrollment
370
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 02 Oct 2020
Primary Completion Date: 11 May 2022
Estimated Study Completion Date: 28 Jun 2024
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Feb 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Innate Pharma
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2 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. | Drug: Monalizumab Participants will receive IV infusion of monalizumab as stated in arm description. Other Name: IPH2201 Drug: Cetuximab Participants will receive IV infusion of cetuximab as stated in arm description. Other Name: Erbitux |
| Active Comparator: Placebo Q2W + Cetuximab 400 mg/m^2 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. | Drug: Cetuximab Participants will receive IV infusion of cetuximab as stated in arm description. Other Name: Erbitux Other: Placebo Participants will receive IV infusion of placebo as stated in arm description. Other Name: Not Applicable |
Contacts
Investigators
Principal Investigator
Roger B Cohen
Abramson Cancer Center, Perelman Center for Advanced Medicine
