NCT04373642

"QUAD SHOT" Radiotherapy With Pembrolizumab in Patients With Recurrent Head & Neck Cancer

A Single-arm Phase II Trial of Palliative "QUAD SHOT" Radiotherapy Combined With Pembrolizumab in Patients With Recurrent Head & Neck Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the safety of palliative "QUAD SHOT" radiotherapy combined with pembrolizumab and evaluate the effects of the combination treatment patients with recurrent cancer of head and neck.

Detailed description

During this study, patients will receive infusions of pembrolizumab with radiotherapy (palliative QUADSHOT regimen). The patient will receive treatment of pembrolizumab once every 3 weeks and palliative "QUAD SHOT" radiotherapy every 4 weeks. These 28 day period of time is called a cycle. The cycle will be repeated 3 times. Each cycle is numbered in order. The patient will be treated for up to 3 cycles followed by pembrolizumab single drug until unacceptable toxicity or tumor progression. The patient will also complete a survey. Total duration of the study is up to two years.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Pebrolizumab + QUADSHOT Radiotherapy	Treatment will consist of "QUAD SHOT" radiotherapy combined with pembrolizumab.

Timeline

• Start date: 2020-12-23
• Primary completion: 2026-01-01
• Completion: 2026-10-01
• First posted: 2020-05-04
• Last updated: 2025-07-24

Locations

1 site across 1 country: United States