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Immunoradiotherapy for Head and Neck Cancer

Phase 1 & 2

Waitlist Available

Led By Rom Leidner, MD

Research Sponsored by Providence Health & Services

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with HPV status as determined by p16 immunostain

Patients with squamous cell carcinoma of the head and neck region planned for surgical resection and deemed able to safely undergo neoadjuvant anti-PD-1 and radiation

Must not have

Need for chronic maintenance with oral steroids ≥20mg daily prednisone equivalent

HNSCC for which radiation is not indicated during normal treatment course

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if immunoradiotherapy can safely shrink HNSCC tumors before surgery.

Who is the study for?

Adults with head and neck squamous cell carcinoma scheduled for surgery can join. They must have certain blood counts, be HPV status known, able to consent, and have an acceptable performance status. Pregnant women or those not using contraception are excluded, as well as individuals on high-dose steroids or with active autoimmune diseases.

What is being tested?

The trial is testing if giving Nivolumab (an immunotherapy drug) combined with a short course of radiation before surgery can safely shrink tumors in patients with head and neck cancer. The study will separate participants into groups based on their HPV status.

What are the potential side effects?

Nivolumab may cause immune-related side effects like inflammation in various organs, skin rash, hormone gland problems (like thyroid), fatigue, and infusion reactions. Radiation could lead to skin irritation at the treatment site and general tiredness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer's HPV status has been checked.

Select...

I have squamous cell carcinoma in the head or neck and am set for surgery with pre-surgery anti-PD-1 and radiation.

Exclusion Criteria

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

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I take 20mg or more of prednisone or its equivalent daily.

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My head or neck cancer does not require radiation as part of standard treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Neoadjuvant Therapy

Secondary study objectives

Number of patients with decrease in tumor size or number of lymph nodes involved [Efficacy of Neoadjuvant Treatment]

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717

80%

Fatigue

70%

Diarrhoea

70%

Headache

40%

Vomiting

40%

Aspartate aminotransferase increased

40%

Rash maculo-papular

40%

Alanine aminotransferase increased

40%

Lipase increased

30%

Partial seizures

30%

Hemiparesis

30%

Gait disturbance

30%

Fall

30%

Cough

30%

Dry skin

30%

Amylase increased

30%

Nausea

30%

Confusional state

20%

Malignant neoplasm progression

20%

Pyrexia

20%

Candida infection

20%

Mucosal infection

20%

Decreased appetite

20%

Back pain

20%

Dysphonia

20%

Hypotension

20%

Colitis

20%

Hyperthyroidism

20%

Oedema peripheral

20%

Muscular weakness

20%

Hypothyroidism

10%

Tinnitus

10%

Cushingoid

10%

Diabetic ketoacidosis

10%

Procedural haemorrhage

10%

Blood bilirubin increased

10%

Bradycardia

10%

Sinus tachycardia

10%

Hyperglycaemia

10%

Hypocalcaemia

10%

Neck pain

10%

Brain oedema

10%

Hydrocephalus

10%

Lethargy

10%

Seizure

10%

Hypertension

10%

Palpitations

10%

Cheilitis

10%

Presyncope

10%

Face oedema

10%

Oedema

10%

Conjunctivitis

10%

Enterocolitis infectious

10%

Oral candidiasis

10%

Pneumonia

10%

Sinusitis

10%

Staphylococcal infection

10%

Blood alkaline phosphatase increased

10%

Spinal pain

10%

Tremor

10%

Dizziness

10%

Dysarthria

10%

Urinary retention

10%

Dyspnoea exertional

10%

Nasal congestion

10%

Pneumonitis

10%

Dermatitis

10%

Erythema

10%

Rash

10%

Klebsiella infection

10%

Hypomagnesaemia

10%

Syncope

10%

Haemorrhage intracranial

10%

Pancreatitis

10%

Cholecystitis

10%

Upper respiratory tract infection

10%

Acute kidney injury

10%

Dermatitis bullous

10%

Lymphopenia

10%

Optic nerve disorder

10%

Visual impairment

10%

Dehydration

10%

Hypokalaemia

10%

Scoliosis

10%

Cognitive disorder

10%

Memory impairment

10%

Hallucination

10%

Insomnia

10%

Irritability

10%

Urinary incontinence

10%

Dyspnoea

10%

Dermatitis acneiform

10%

Pelvic venous thrombosis

10%

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1: Arm N1+I3

Cohort 2: Arm B

Part A Cohort 1c: Arm N3+RT+TMZ

Part A Cohort 1d: Arm N3+RT

Part B Cohort 1c: Arm N3+RT+TMZ

Part B Cohort 1d: Arm N3+RT

Cohort 1: Arm N3

Cohort 1b: Arm N3+I1

Cohort 2: Arm N3

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Treatment Cohort 4Experimental Treatment3 Interventions

Nivolumab administration (3 doses) and radiation (3 days) therapy prior to restaging and surgical resection followed by additional administration of nivolumab (3 doses).

Group II: Treatment Cohort 3Experimental Treatment3 Interventions

Radiation (3 days) therapy prior to restaging and surgical resection followed by additional administration of nivolumab (3 doses).

Group III: Treatment Cohort 2Experimental Treatment3 Interventions

Nivolumab administration (3 doses) and radiation (3 days) therapy prior to restaging and surgical resection followed by additional administration of nivolumab (3 doses).

Group IV: Treatment Cohort 1Experimental Treatment3 Interventions

Nivolumab administration (3 doses) and radiation (5 days) therapy prior to restaging and surgical resection followed by additional administration of nivolumab (3 doses).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

Surgical Resection

2018

Completed Phase 2

~420