NCT02643550

Study of Monalizumab and Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Phase 1b/2 Trial of IPH2201 And Cetuximab in Patients With Human Papillomavirus (HPV) (+) and HPV (-) Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Innate Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate in a 3 +3 design, the safety of escalating doses of Monalizumab given IV in combination with cetuximab in patients who have received prior systemic regimen(s) for recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). Cohorts expansion will evaluate antitumor activity of monalizumab and cetuximab with or without anti-PD(L)1

Conditions

• Head and Neck Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	Monalizumab
BIOLOGICAL	Cetuximab
BIOLOGICAL	Anti-PD(L)1

Timeline

• Start date: 2015-12-01
• Primary completion: 2023-03-28
• Completion: 2023-03-28
• First posted: 2015-12-31
• Last updated: 2023-05-12

Locations

18 sites across 2 countries: United States, France