NCT02538510

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

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Head and Neck Squamous Cell Carcinoma
• Recurrent Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
• Recurrent Nasopharynx Carcinoma
• Recurrent Salivary Gland Carcinoma
• Squamous Cell Carcinoma Metastatic in the Neck With Occult Primary
• 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

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Pembrolizumab	Given IV
DRUG	Vorinostat	Given PO or via PEG

Timeline

• Start date: 2015-10-08
• Primary completion: 2019-09-28
• Completion: 2023-09-15
• First posted: 2015-09-02
• Last updated: 2024-11-26
• Results posted: 2020-10-22

Locations

1 site across 1 country: United States