Phsae III, Monalizumab in Recurrent/Metastatic Head and Nect Cancer
Research type
Research Study
Full 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. INTERLINK-1
IRAS ID
284115
Contact name
Karishma Varsani
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2019-004770-25
Duration of Study in the UK
2 years, 10 months, 27 days
Research summary
Study D7310C00001 is a phase 3, randomized, double-blind, multicenter, global study. The purpose of this study is to assess the safety and efficacy of monalizumab or placebo in combination with cetuximab in patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) not amenable to curative treatment previously treated with platinum-based chemotherapy and an immune checkpoint inhibitor (ICI), regardless of the sequence of these therapies. Approximately 750 participants will be enrolled to achieve approximately 600 participants randomly assigned to study intervention. Following a 28-day screening period, eligible participants will be randomized in a 2:1 ratio to one of the following treatment arms: (1) Arm A: monalizumab and cetuximab or (2) Arm B: placebo and cetuximab. Participants will receive study intervention until RECIST 1.1-defined radiological disease progression per investigator, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. Efficacy and safety assessments will be performed periodically from the time of enrolment and throughout the study. An independent data monitoring committee will review safety data regularly and make recommendations regarding further study conduct. After discontinuation of study intervention, all participants will have safety follow-up for 3 months after their lost dose of study intervention. After study intervention discontinuation, all participants will be followed for survival status, subsequent anticancer therapy, and time to disease progression occurring during or after subsequent therapy until death, withdrawal of consent, or end of the study.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
20/EM/0245
Date of REC Opinion
11 Dec 2020
REC opinion
Further Information Favourable Opinion