Cemiplimab and Cetuximab Prior Salvage Surgery in Patients With Recurrent Oral Cavity and HPV-negative Oropharyngeal Squamous Cell Carcinoma
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: \- Primary Objectives To evaluate the clinical efficacy, defined as overall response rate, of cemiplimab combined with cetuximab in patients with recurrent oral cavity and HPV-negative oropharynx squamous cell carcinoma. Secondary Objective: -To evaluate other markers of clinical efficacy (pathological response rates, objective response rate per RECIST, overall survival) and safety. Exploratory Endpoints * To explore patient-reported outcomes (PRO) during CC and following salvage surgical resection * Assess impact of cemiplimab and cetuximab on surgery and adjuvant ther…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subjects .18 years with histology-proven locoregionally recurrent oral cavity squamous cell carcinoma or HPV-negative OPSCC 2. HPV testing is required only in oropharyngeal sites and must be negative 3. Amenable to salvage surgery 4. Disease recurrence at least 3 months after completion of curative-intent therapy, which must include at least surgery and post operatory radiation. Previous systemic therapy is the curative-setting is not required but allowed (e.g., neoadjuvant chemotherapy, concurrent chemotherapy). 5. Measurable disease per RECIST 1.1 6. Performance statu…
Interventions
- DrugCemiplimab
Given by IV
- DrugCetuximab
Given by IV
Location
- MD Anderson Cancer CenterHouston, Texas