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

NCT03532737 PHASE2 UNKNOWN

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)

Details

Lead sponsor	Kuwait Cancer Control Center
Phase	PHASE2
Status	UNKNOWN
Enrolment	50
Start date	Sun Oct 07 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Fri Oct 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Locally Advanced Head and Neck Cancer

Interventions

• Pembrolizumab

Countries

Kuwait