Neoplasms

All Conditions

Symptoms and General Pathology

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Recurrence

Head and Neck Neoplasms

Nasopharyngeal Carcinoma

Squamous Cell Carcinoma of Head and Neck

Salivary Gland Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Neoplasms, Squamous Cell

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Mouth Neoplasms

Mouth Diseases

Salivary Gland Diseases

Oral Cancer

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Vorinostat

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Histone Deacetylase Inhibitors

Enzyme Inhibitors

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.

Laboratory Biomarker Analysis

Cristina Rodriguez

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.

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.

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

Toxicities will be summarized as the number and percentage of patients with each type of toxicity, per Criteria for Adverse Events version 4.0

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.

The Kaplan Meier methods will be used to estimate overall survival.

The Kaplan Meier methods will be used to estimate progression free survival.

National Cancer Institute (NCI)

University of Washington

Adverse events are collected from the first dose of Mk-3475 or Vorinostat, and are collected through 30 days post the last dose of therapy.

MK-3475 combined with vorinostat in HNSCC patients

Head and Neck Squamous Cell Carcinoma

MK-3475 combined with vorinostat in SGC patients

Salivary Gland Carcinoma

Head and Neck Squamous Cell Carcinoma patients

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

RMHNSCC with the following primary sites:nasopharynx, paranasal sinus, nasal cavity, skin/cutaneous sites. Pts with unknown HN primary sites will be enrolled. Patients with biopsy proven RMSGC be eligible as well

Adrenal insufficiency

ALT increase

Anorexia

Arthiritis

AST increase

Cough

Increased Creatinine

Dermatitis

Diarrhea

Fever with leukocytosis

Fatigue

Hyponatremia

Hypothyroidism

Colitis and Ileitis

Malaise

Nausea

Nephritis

Pneumonitis

Neuritis

Tracheitis/Epiglottitis

Vomiting

AEs experienced with MK-3475 combined with vorinostat in HNSCC patients

AEs experienced with MK-3475 combined with vorinostat in salivary gland carcinoma patients

Only G3 toxicities and toxicities requiring dose hold/reduction recorded.

Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

partial response

stable disease

progressive disease

Head and Neck Squamous Cell

6 patients were not evaluated as they did not have at least 1 set of follow up scans while on study, (N=2 salivary patients, N=4 SCC patients)

Spots Global Cancer Trial Database for stage iii nasal cavity and paranasal sinus squamous cell carcinoma