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
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 70
Summary
- Conditions
- Stage IV Nasopharyngeal Carcinoma
- Head and Neck Squamous Cell Carcinoma
- Recurrent Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
- Recurrent Nasopharynx Carcinoma
- Stage IVB Major Salivary Gland Carcinoma
- Stage IVC Major Salivary Gland Carcinoma
- Recurrent Salivary Gland Carcinoma
- Squamous Cell Carcinoma Metastatic in the Neck With Occult Primary
- Stage IVB Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
- Stage III Major Salivary Gland Carcinoma
- Stage III Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
- Stage III Nasopharyngeal Carcinoma
- Stage IVA Major Salivary Gland Carcinoma
- Stage IVC Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
- Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. Determine the safety and tolerability of MK-3475 (pembrolizumab) in combination with vorinostat patients with recurrent metastatic head and neck squamous cell carcinoma (RMHNSCC) and recurrent metastatic salivary gland cancer (RMSGC). SECONDARY OBJECTIVES: I. Determine the obj...
PRIMARY OBJECTIVES: I. Determine the safety and tolerability of MK-3475 (pembrolizumab) in combination with vorinostat patients with recurrent metastatic head and neck squamous cell carcinoma (RMHNSCC) and recurrent metastatic salivary gland cancer (RMSGC). SECONDARY OBJECTIVES: I. Determine the objective response rates and disease control rates of the combination of MK-3475 and vorinostat in patients with RMHNSCC and RMSGC. II. Examine programmed cell death ligand 1 (PD-L1) expression and T cell phenotype in archived tumor, on-treatment tumor biopsies, pre- and post-treatment blood samples and correlate these with clinical response to the drug combination. III. Determine median overall survival and progression free survival in and RMHNSCC and RMSGC patients enrolled in the study. TERTIARY OBJECTIVES: I. Explore peripheral T cell phenotype at baseline and after 3 cycles vorinostat and MK-3475. II. Measure expression of the proteins in the PD-1 family on baseline tumor samples and on treatment biopsies. 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.
Tracking Information
- NCT #
- NCT02538510
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Cristina Rodriguez Fred Hutch/University of Washington Cancer Consortium
Get Well Soon