At a glance
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Quad-Shot Radiotherapy in Combination With Immune Checkpoint Inhibition for Advanced/Recurrent Head and Neck Cancer
In Brief
A Phase 2 clinical trial evaluating Pembrolizumab (immunotherapy) and Quad-shot palliative radiotherapy for Advanced Head and Neck Squamous Cell Carcinoma and 5 related conditions. Completed, enrolled 21 participants across 1 site.
Detailed Summary
This is a single-arm, non-randomized pilot study to evaluate the efficacy and tolerability of combination quad-shot palliative radiotherapy with immunotherapy for advanced/recurrent/metastatic head and neck cancer.
Study Details
Timeline
Interventions
Pembrolizumab 200 mg will be given every 3 weeks to tumor progression or treatment tolerance.
* 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