Pembrolizumab in Treating Patients with Recurrent Stage III-IVB Head and Neck Squamous Cell Cancer

Active:	No
Cancer Type:	Head and Neck Cancer	NCT ID:	NCT02841748
Trial Phases:	Phase II	Protocol IDs:	IRB15-1632 (primary) NCI-2017-00951
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	University of Chicago Comprehensive Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT02841748

Summary

This randomized phase II trial studies how well pembrolizumab works in treating patients with stage III-IVB head and neck squamous cell cancer that has come back. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Objectives

PRIMARY OBJECTIVE:
I. Progression free survival (PFS).

SECONDARY OBJECTIVES:
I. PFS, in gene expression profile (GEP) positive patients.
II. PFS, in PD-L1 > 10% positive patients.
III. Overall survival (OS), in the overall patient population, and in gene expression signature (GES) positive or PD-L1 positive (>= 10%) patients.

EXPLORATORY OBJECTIVES:
I. Gene expression profile, head and neck cancer (HNC) intrinsic subtype determination, and broader ribonucleic acid sequencing (RNAseq) analysis: correlation with recurrence.
II. Gene expression profile evaluation in blood at baseline and 3-4 week after pembrolizumab treatment and correlation with recurrence.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

GROUP II: Patients receive placebo IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, and then every 12-16 weeks for 2 years.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.