Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Head and Neck Cancer
  • Head and Neck Neoplasms
  • Head and Neck Squamous Cell Carcinoma
Type
Interventional
Phase
Phase 2
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Enrollment into each cohort will occur independently in a non-randomized fashion, based on PD-L1 expression results. Patients may not crossover between cohorts.Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This is an open-label, non-randomized study of approximately 80 patients. Enrollment into each cohort will occur independently, with 50 programmed cell death ligand 1 (PD-L1)-positive patients enrolled in the retifanlimab cohort, and 30 PD-L1-negative patients enrolled in the tebotelimab cohort.

This is an open-label, non-randomized study of approximately 80 patients. Enrollment into each cohort will occur independently, with 50 programmed cell death ligand 1 (PD-L1)-positive patients enrolled in the retifanlimab cohort, and 30 PD-L1-negative patients enrolled in the tebotelimab cohort.

Tracking Information

NCT #
NCT04634825
Collaborators
Not Provided
Investigators
Study Director: Fernanda Arnaldez, MD MacroGenics