Quad Shot Radiotherapy in Combination With Immune Checkpoint Inhibition

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT04454489
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Head and Neck Squamous Cell Carcinoma
  • Locally Advanced Head and Neck Squamous Cell Carcinoma
  • Metastatic Head-and-neck Squamous-cell Carcinoma
  • Recurrent Head and Neck Squamous Cell Carcinoma
  • Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck
  • Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab (immunotherapy) — DRUG
    Pembrolizumab 200 mg will be given every 3 weeks to tumor progression or treatment tolerance.
  • Quad-shot palliative radiotherapy — RADIATION
    * 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

Study Details

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.

Key Dates

Start date
Feb 25, 2021
Status verified
Nov 2025
Primary completion
Feb 18, 2025
Completion
Apr 30, 2025

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Quad-shot palliative radiotherapy and Immunotherapy
    Systemic therapy (ICI) and radiotherapy will be administered according to the standard of care, according to the treating medical oncologist and radiation oncologist, respectively

Primary Outcome Measure

Overall Response - [ Time Frame: Up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest Baptist Comprehensive Cancer CenterWinston-SalemNorth Carolina27157-

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By research site
Wake Forest Baptist Comprehensive Cancer Center· Winston-Salem, NC

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