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SBRT + Pembrolizumab for Head and Neck Cancer (KEYSTROKE Trial)

Phase 2

Recruiting

Led By Stuart J. Wong, MD

Research Sponsored by RTOG Foundation, Inc.

Eligibility Criteria Checklist

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

Must have

Disease must be limited to a single site or adjacent sites that can be treated in a single contiguous target volume with a maximum total tumor dimension <7.5cm

Hematologic, hepatic, renal, and coagulation criteria within specified ranges

Must not have

History of pneumonitis that required steroids or current pneumonitis

Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization within 30 days of entry

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate whether adding pembrolizumab to Stereotactic Body Radiation Therapy (SBRT) re-irradiation will improve progression-free survival for patients with recurrent or new second primary Head and Neck Squamous Cell Carcinoma (HNSCC).

Who is the study for?

This trial is for adults with a confirmed diagnosis of head and neck squamous cell carcinoma that has come back or is a new second primary. It's not for those who can be cured by surgery without high risk, have distant metastases, recent other cancer treatments, immune deficiencies, certain heart conditions within the last 6 months, active infections needing IV antibiotics, pregnant or breastfeeding women, or those unwilling to use contraception.

What is being tested?

The study tests if adding Pembrolizumab (an immunotherapy drug) to Stereotactic Body Radiation Therapy improves progression-free survival in patients with recurrent or new head and neck cancer. The phase II trial includes an initial safety review before fully proceeding.

What are the potential side effects?

Pembrolizumab may cause immune system-related side effects like inflammation in various organs including lungs (pneumonitis), liver issues, skin reactions; it could also lead to fatigue and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is in one area or close areas, all under 7.5cm in size.

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My blood, liver, kidney, and clotting tests are within normal ranges.

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My head or neck cancer cannot be removed with surgery.

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Surgery to remove my cancer is not an option for me due to high risk or medical reasons.

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I am 18 years old or older.

Exclusion Criteria

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

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I have had or currently have lung inflammation treated with steroids.

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I haven't been hospitalized for lung problems in the last 30 days.

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My cancer has spread to distant parts of my body.

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

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I have an active hepatitis B or C infection.

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I am not pregnant, nursing, or able to become pregnant and will use contraception.

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My cancer is visible on my skin.

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I haven't been hospitalized for heart issues in the last 6 months.

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My condition needs treatment in two or more separate areas.

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My cancer cannot be removed with surgery.

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I am currently on IV antibiotics for a bacterial or fungal infection.

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I am not on steroids or any immunosuppressive drugs currently.

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I have not received a live vaccine in the last 30 days.

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I have been treated with a checkpoint inhibitor before.

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My tumor affects a large part of the artery in my neck and is open to skin or inside my mouth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression Free Survival (PFS)

Secondary study objectives

Overall Survival (OS)

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

2Treatment groups

Experimental Treatment

Group I: Arm IIExperimental Treatment1 Intervention

Patients receive Stereotactic Body Radiation Therapy (SBRT) over 2 weeks. Arm II patients who experience progressive disease within 2 years after the start of SBRT will be allowed to cross over to receive pembrolizumab for up to 2 years.

Group II: Arm IExperimental Treatment2 Interventions

Patients receive Stereotactic Body Radiation Therapy (SBRT) over 2 weeks and then receive pembrolizumab every 3 weeks for up to 2 years.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Stereotactic Body Radiation Therapy (SBRT)

2018