Quad Shot Radiotherapy in Combination With Immune Checkpoint Inhibition

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

February 25, 2021

Primary Completion Date

February 18, 2025

Study Completion Date

February 28, 2026

Conditions
Advanced Head and Neck Squamous Cell CarcinomaRecurrent Head and Neck Squamous Cell CarcinomaMetastatic Head-and-neck Squamous-cell CarcinomaStage III Cutaneous Squamous Cell Carcinoma of the Head and NeckLocally Advanced Head and Neck Squamous Cell CarcinomaStage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck
Interventions
DRUG

Pembrolizumab (immunotherapy)

Pembrolizumab 200 mg will be given every 3 weeks to tumor progression or treatment tolerance.

RADIATION

Quad-shot palliative radiotherapy

"* Each cycle of quad-shot radiotherapy will be comprised of 14.8 Gy in 4 fractions (3.7 Gy per fraction) delivered twice daily (at least 6 hours apart) over two consecutive days.~* All patients will receive 1 cycle of quad-shot radiotherapy between ICI cycles 2-3.~* Subsequent cycles may occur between immunotherapy cycles 6-7 and 11-12, if more than 1 cycle can be safely delivered and the patient has experienced less than a partial response at protocol-specified tumor assessments (after C5 and C10). The eligibility for subsequent cycles will be at the discretion of the treating radiation oncologist.~Therefore, the total prescription dose will be:~* 14.8 Gy in 4 fractions for those that complete 1 cycle (all patients will receive 1 cycle)~* 19.6 Gy in 8 fractions for those that complete 2 cycles~* 44.4 Gy in 12 fractions for those that complete 3 cycles"

Trial Locations (1)

27157

Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Wake Forest University Health Sciences

OTHER