Cemiplimab and Cetuximab Prior Salvage Surgery in Patients With Recurrent Oral Cavity Squamous Cell Carcinoma (OCSCC).
M.D. Anderson Cancer Center
Summary
To learn if giving cemiplimab and cetuximab before salvage surgery can help to control recurrent oral cavity squamous cell carcinoma.
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 sur…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participants ≥18 years with histology-proven recurrent oral cavity squamous cell carcinoma. 2. Amenable to salvage surgery 3. Disease recurrence at least 3 months after completion of curative-intent therapy (including surgery, post operatory radiation, and/or chemotherapy) 4. Measurable disease per RECIST 1.1 5. Performance status ECOG of 0 or 1 6. Willing to undergo baseline (if archival tumor specimen is not available) and on-treatment biopsy for correlative studies 7. Laboratory measurements, blood counts: 1. Hemoglobin ≥ 9 g/dL. Red blood cell transfusions are p…
Interventions
- DrugCemiplimab
Given by IV
- DrugCetuximab
Given by IV
Location
- MD Anderson Cancer CenterHouston, Texas