Phase II Study of First Line Weekly Chemo/Immunotherapy for Metastatic Head/Neck Squamous Cell Carcinoma Patients
Wake Forest University Health Sciences
Summary
The purpose of this research is to see what effects the treatment regimen chemotherapy (carboplatin and paclitaxel) plus immunotherapy (pembrolizumab), has on patients who have been diagnosed with head/neck squamous cell carcinoma and are unable to take the drug 5-fluorouracil
Description
Primary Objective: To determine if six (6) cycles of pembrolizumab with weekly carboplatin and paclitaxel for the 1st line treatment of metastatic head/neck squamous cell carcinoma patients increases the radiographic response rate as compared to the historical rate for pembrolizumab alone. Secondary Objective(s): * To determine if six (6) cycles of pembrolizumab with weekly carboplatin and paclitaxel for the 1st line treatment of metastatic head/neck squamous cell carcinoma patients increases median overall survival (OS) as compared to the historical rate reported for pembrolizumab alone. *…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Recurrent or metastatic squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, larynx or neck node with occult primary but suspected to be non-cutaneous head/neck that is incurable by local therapies (i.e. radiation or surgery) and either locoregionally advanced or with at least one distant metastasis. * Histologic or cytologic confirmation of malignancy by pathology report. * Not a candidate for infusional 5FU (mucositis, 5-day infusional pump not feasible, patient refusal, other). * 18 years old or greater. * ECOG performance status of 0-2. * Life expecta…
Interventions
- DrugPembrolizumab
Pembrolizumab 200 mg intravenously (IV) on day 1 of each 3-week cycle
- DrugCarboplatin
Carboplatin dosed for area under the curve (AUC) 1.5 IV on days 1, 8, 15 of each 3-week cycle
- DrugPaclitaxel
Paclitaxel 45 mg/m2 on days 1, 8, 15 of 3-week cycle.
Location
- Wake Forest Baptist Health SciencesWinston-Salem, North Carolina