Study identifier:D7310C00001
ClinicalTrials.gov identifier:NCT04590963
EudraCT identifier:2019-004770-25
CTIS identifier:2024-511813-39-00
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
Squamous cell carcinoma of the head and neck
Phase 3
No
Monalizumab, Cetuximab
All
370
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Feb 2025 by AstraZeneca
AstraZeneca
Innate Pharma
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.
Participants 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 randomized in a 2:1 ratio to monalizumab and cetuximab or placebo and cetuximab. Efficacy and safety assessments will be performed periodically from the time of enrollment and throughout the study. Participants in all arms will continue therapy until progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. All Participants will be followed for survival after progression is confirmed.
Location
Location
Philadelphia, PA, United States, 19104
Location
Seoul, Republic of Korea, 110-744
Location
Seoul, Republic of Korea, 138-736
Location
Kashiwa, Japan, 277-8577
Location
Osakasayama, Japan, 589-8511
Location
Amsterdam, Netherlands, 1066 CX
Location
Seoul, Republic of Korea, 06351
Location
Seongnam-si, Republic of Korea, 13620
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 |
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