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Pembrolizumab in Combination With Cisplatin and Intensity Modulated Radiotherapy (IMRT) in Head and Neck Cancer

NCT02777385 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-08-01

Study results available
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Summary

The goal of this research study is to learn which therapy order (adding pembrolizumab during vs. after cisplatin and radiation) may be more effective in treating head and neck cancer, as well as learn the side effects of these combinations. Pembrolizumab is an immune therapy, a drug that stimulates the immune system to fight cancer, and is FDA approved in lung cancer and melanoma.

Conditions

Interventions

DRUG

Pembrolizumab

In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.

DRUG

Cisplatin

Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.

RADIATION

IMRT

IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.

Sponsors & Collaborators

Principal Investigators

  • Dan Zandberg, MD · UPMC Hillman Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2023-04-24
Completion
2023-05-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02777385 on ClinicalTrials.gov