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Neoadjuvant Immunoradiotherapy for Head and Neck Cancer

Phase 2
Recruiting
Led By R. Bryan Bell, MD, DDS, FACS
Research Sponsored by Providence Health & Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed diagnosis of stage III-IVA HPV-negative HNSCC planned for surgical resection and able to safely undergo neoadjuvant anti-PD-1 and radiation
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 year
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that combines immunotherapy and radiotherapy given before surgery for people with stage III or IVA HPV-associated head and neck squamous cell carcinoma.

Who is the study for?
Adults with stage III-IVA HPV-negative head and neck squamous cell carcinoma (HNSCC) who are candidates for surgery. They must have proper organ function, not be pregnant or breastfeeding, agree to use contraception, and have an ECOG performance status of 0 to 1. Excluded are those with prior head & neck radiotherapy, recent live vaccines, active autoimmune diseases requiring treatment in the past 2 years, active infections needing systemic therapy, certain psychiatric/substance abuse disorders.Check my eligibility
What is being tested?
The trial is testing neoadjuvant immunoradiotherapy (NIRT) using Pembrolizumab combined with Stereotactic Body Radiation Therapy over five days before surgical resection in patients with HNSCC. The goal is to assess how effective this pre-surgery treatment is at treating cancer.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in various organs including lungs (pneumonitis), liver problems, skin reactions; infusion-related reactions; fatigue; hormonal gland issues like thyroid dysfunction; and can increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is stage III-IVA, HPV-negative, and I'm set for surgery with pre-surgery anti-PD-1 and radiation.
Select...
I am fully active or can carry out light work.
Select...
I am 18 years or older and have given my consent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine the pathologic response rate (MPR + pCR) at time of surgery
Secondary outcome measures
Adverse events
Clinical swallowing evaluation assessed by VFSS
Overall Response Rate
+7 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pembrolizumab + SBRT + SurgeryExperimental Treatment3 Interventions
Pembrolizumab administration (3 dose) every 3 weeks and 1 dose before radiation (5 days) therapy followed by an additional administration of Pembrolizumab (2 doses) prior to restaging and surgical resection followed by risk-adapted adjuvant therapy, per standard of care. Patient will then be treated with adjuvant pembrolizumab every 3 weeks for 14 additional doses (17 doses total)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Surgical Resection
2018
Completed Phase 2
~420

Find a Location

Who is running the clinical trial?

Providence Cancer Center, Earle A. Chiles Research InstituteOTHER
18 Previous Clinical Trials
450 Total Patients Enrolled
Providence Health & ServicesLead Sponsor
119 Previous Clinical Trials
822,559 Total Patients Enrolled
R. Bryan Bell, MD, DDS, FACSPrincipal InvestigatorProvidence Health & Services

Media Library

Stereotactic Body Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04938609 — Phase 2
Head and Neck Squamous Cell Carcinoma Research Study Groups: Pembrolizumab + SBRT + Surgery
Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Stereotactic Body Radiation Therapy Highlights & Side Effects. Trial Name: NCT04938609 — Phase 2
Stereotactic Body Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04938609 — Phase 2
~14 spots leftby Jan 2027
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