NCT06448026

Cemiplimab and Cetuximab Prior Salvage Surgery in Patients With Recurrent Oral Cavity Squamous Cell Carcinoma (OCSCC).

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if giving cemiplimab and cetuximab before salvage surgery can help to control recurrent oral cavity squamous cell carcinoma.

Detailed description

Primary Objective: \- To assess the efficacy of cemiplimab and cetuximab in patients with recurrent oral cavity squamous cell carcinoma Secondary Objective: * To assess safety of cemiplimab and cetuximab prior salvage surgery * To evaluate the efficacy of cemiplimab and cetuximab prior salvage surgery on measures * To estimate the one-year disease free survival (DFS) * To estimate the median overall survival (OS) Tertiary/Exploratory Objective: * To explore patient-reported outcomes (PRO) during CC and following salvage surgical resection * Assess impact of cemiplimab and cetuximab on surgery and adjuvant therapy * To explore biomarkers that may predict response to therapy

Conditions

• Locally Recurrent Oral Cavity Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Cemiplimab	Given by IV
DRUG	Cetuximab	Given by IV

Timeline

• Start date: 2024-11-21
• Primary completion: 2027-05-15
• Completion: 2027-05-15
• First posted: 2024-06-07
• Last updated: 2025-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study