Pembrolizumab and Vorinostat in Treating Patients With Recurrent Squamous Cell Head and Neck Cancer or Salivary Gland Cancer That Is Metastatic and/or Cannot Be Removed by Surgery

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:
A Single Arm Phase I/II Study of MK-3475 Combined With Vorinostat for Recurrent Unresectable and/or Metastatic Squamous Cell Head and Neck Cancer and Recurrent Unresectable and/or Metastatic Salivary Gland Malignancies

Status Completed

Clinical Trial Summary

This phase I/II trial studies the side effects of pembrolizumab and vorinostat in treating patients with squamous cell head and neck cancer or salivary gland cancer that has come back, has spread to other places in the body and/or cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab together with vorinostat may be a better treatment for head and neck cancer or salivary gland cancer.

Clinical Trial Description

OUTLINE: Patients receive vorinostat orally (PO) once daily (QD) or via percutaneous endoscopic gastrostomy (PEG) on days 1-5 and pembrolizumab intravenously (IV) over 30 minutes on day 1. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and every 8-12 weeks thereafter. ;

Study Design

Related Conditions & MeSH terms

Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Head and Neck Squamous Cell Carcinoma
Nasopharyngeal Carcinoma
Recurrence
Recurrent Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
Recurrent Nasopharynx Carcinoma
Recurrent Salivary Gland Carcinoma
Salivary Gland Neoplasms
Squamous Cell Carcinoma Metastatic in the Neck With Occult Primary
Squamous Cell Carcinoma of Head and Neck
Stage III Major Salivary Gland Carcinoma
Stage III Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
Stage III Nasopharyngeal Carcinoma
Stage IV Nasopharyngeal Carcinoma
Stage IVA Major Salivary Gland Carcinoma
Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
Stage IVB Major Salivary Gland Carcinoma
Stage IVB Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
Stage IVC Major Salivary Gland Carcinoma
Stage IVC Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma

Clinical Trial Details

NCT number	NCT02538510
Study type	Interventional
Source	University of Washington
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	October 8, 2015
Completion date	September 15, 2023

View Details

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