Combination chemo treatment for recurrent / metastatic head and neck cancer
Protocol: STUDY00005605
Full Title
A Phase 4, single-arm, open-label clinical study of pembrolizumab (MK- 3475) to evaluate the efficacy and safety of MK-3475 plus carboplatin and paclitael as firstline treatment of recurrent/metastatic head and neck squamous cell carcinoma (KEYNOTE10).
Description
This study looks at the safety and efficacy of the combination of Pembrolizumab, Carboplatin, & Paciltaxel for patients with incurable head and neck cancer that has returned after being treated or has spread to other body parts. The study will take place at ECMC and can last 2-3 years.
Compensation: No
Eligibility
-Has histologically or cytologically-confirmed diagnosis of recurrent / metastatic head and neck squamous cell carcinoma (HNSCC) that is considered incurable by local therapies.
-Has not had prior systemic therapy administered in the recurrent or metastatic setting. Systemic therapy, which was completed more than 6 months prior to signing consent, if given as part of multimodal treatment for locally advanced disease, is allowed.
-Has a primary tumor location of oropharynx, oral cavity, hypopharynx, or larynx.
-Does not have a primary tumor site of nasopharynx (any histology)
-Does not have an unknown primary tumor.
-Does have M1/Stage IV disease if newly-diagnosed with HNSCC.
-Has an ECOG performance status of 0 or 1.
Age Group: Adults
Principal Investigator: THOM LOREE
ClinicalTrials.gov: Open Study
Contact(s)
JAMES ZEMER
jameszem@buffalo.edu
+1 716-645-2521
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