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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

Must not have

Patients with pre-existing neuropathy of grade 2 or higher peripheral neuropathy

Known active CNS metastases and/or carcinomatous meningitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 year

Awards & highlights

No Placebo-Only Group

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.

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.

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

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My cancer is stage III-IVA, HPV-negative, and I'm set for surgery with pre-surgery anti-PD-1 and radiation.

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I am fully active or can carry out light work.

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I am 18 years or older and have given my consent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have moderate to severe nerve damage in my hands or feet.

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I have active brain metastases or carcinomatous meningitis.

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I have an immune system disorder or I'm on long-term steroids.

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My larynx cancer is classified as T1, T2, or T3.

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I have previously been treated with drugs targeting the immune system.

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I have or had lung inflammation that needed steroids.

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I have an active tuberculosis infection.

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I have had radiation therapy to my head or neck.

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I have another cancer that is getting worse or was treated in the last 2 years.

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I have not needed treatment for an autoimmune disease in the last 2 years.

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I am currently on medication for an infection.

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I am a woman of childbearing potential and not pregnant.

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I have a history of HIV, Hepatitis B, or active Hepatitis C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To determine the pathologic response rate (MPR + pCR) at time of surgery

Secondary study objectives

Adverse events

Clinical swallowing evaluation assessed by VFSS

Overall Response Rate

+7 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~3150

Surgical Resection

2018

Completed Phase 2

~420