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

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT02538510
Phase
PHASE1/PHASE2
Status
Completed

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Vorinostat — DRUG
    Given PO or via PEG

Study Details

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.

Key Dates

Start date
Oct 8, 2015
Status verified
Nov 2024
Primary completion
Sep 28, 2019
Completion
Sep 15, 2023

Study Design

Enrollment
50 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109-

Find similar trials in Seattle, WA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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