CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
Pembrolizumab +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02538510
NCT02538510Phase 2Completed
CompareCT.gov

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

University of Washington·interventional·Posted Sep 2, 2015·Updated Nov 26, 2024

In Brief

A Phase 2 clinical trial evaluating Laboratory Biomarker Analysis, Pembrolizumab, and 1 other intervention for Head and Neck Squamous Cell Carcinoma and 14 related conditions. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead 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
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 2, 2015
Enrollment StartOct 8, 2015
Primary CompletionSep 28, 2019
Study CompletionSep 15, 2023
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 10.8 years ago

Interventions

Laboratory Biomarker Analysisother

Correlative studies

Pembrolizumabbiological

Given IV

Vorinostatdrug

Given PO or via PEG