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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02538510|
Recruitment Status : Active, not recruiting
First Posted : September 2, 2015
Last Update Posted : November 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|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||Other: Laboratory Biomarker Analysis Biological: Pembrolizumab Drug: Vorinostat||Phase 1 Phase 2|
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).
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.
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||October 8, 2015|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||June 30, 2019|
Experimental: Treatment (vorinostat, pembrolizumab)
Patients receive vorinostat PO QD or via PEG on days 1-5 and pembrolizumab 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.
Other: Laboratory Biomarker Analysis
Given PO or via PEG
- Incidence of toxicity graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 30 days after the completion of study treatment ]Toxicities will be summarized as the number and percentage of patients with each type of toxicity.
- Objective response rate [ Time Frame: Up to 1 year ]Radiologic assessments of measurable disease will be performed using radiographic imaging. RECIST 1.1 and immune response criteria will be used to assess response to therapy. Responses will be summarized as frequencies and percentages.
- Overall survival [ Time Frame: Up to 1 year ]The Kaplan Meier methods will be used to estimate overall survival.
- Progression free survival [ Time Frame: Up to 1 year ]The Kaplan Meier methods will be used to estimate progression free survival.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02538510
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Cristina Rodriguez||Fred Hutch/University of Washington Cancer Consortium|