MedTrace Logo

Quad Shot Radiotherapy in Combination With Immune Checkpoint Inhibition

NCT04454489 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-11-19

Study results available
· View outcomes & findings →

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.

Conditions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Mercedes Porosnicu, MD · Wake Forest University Health Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-25
Primary Completion
2025-02-18
Completion
2025-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04454489 on ClinicalTrials.gov