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Concomitant Immune Check Point Inhibitor With Radiochemotherapy in Head And Neck Cancer

NCT03532737 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-01-23

No results posted yet for this study

Summary

Background: Locally advanced head and neck cancer (HNC) is a challenge as, in spite of initial good control with chemoradiation, the majority of patients fails systemically. In the last 2 years, immune check points inhibitors (mainly Programmed Death (PD)-1 inhibitors) were approved for metastatic/recurrent HNC. The favorable toxicity profile and durable responses was the main benefit of these drugs along the scope of cancers they were approved for.

Aim of the study and methods: This will be a phase II non-randomized trial to define safety and efficacy of combining the PD-1 inhibitor pembrolizumab given concomitantly with the usual standard of care chemoradiation/bioradiation for locally advanced non-nasopharyngeal HNC. Primary end point will be assessment of toxicity and tolerability while the secondary end points will be response rates (RR) and progression free survival (PFS)

Conditions

  • Locally Advanced Head and Neck Cancer

Interventions

DRUG

Pembrolizumab

Adding PD-1 inhibitor to the standard of care

Sponsors & Collaborators

  • Kuwait Cancer Control Center

    lead OTHER

Principal Investigators

  • Mustafa S El-Sherify, MD · Kuwait Cancer Control Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-07
Primary Completion
2025-09-30
Completion
2025-10-31
FDA Drug
Yes

Countries

  • Kuwait

Study Locations

More Related Trials

Entities

Drugs

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 NCT03532737 on ClinicalTrials.gov