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PD-1 Inhibitor

Pembrolizumab + Cesium-131 for Head and Neck Cancer

Phase 1 & 2

Waitlist Available

Led By Chad Zender, MD

Research Sponsored by University of Cincinnati

Eligibility Criteria Checklist

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

Must have

Patients must have locally recurrent HNSCC and be eligible for salvage surgery

Tumor needs to be deemed resectable

Must not have

Exposed carotid artery preoperatively requiring sacrifice or bypass intra-operatively

Patients with active pharyngo-cutaneous

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial will study the safety and efficacy of combining PD-1 inhibitor and Cesium-131 interstitial brachytherapy in patients with head and neck squamous cell carcinoma.

Who is the study for?

This trial is for individuals with a type of throat cancer called HNSCC that has come back and can be removed by surgery. They should have recovered from any serious side effects if they've had radiation before. People with exposed arteries in the neck, ongoing skin-throat connections, or more than one area of cancer spread far away can't join.

What is being tested?

The study tests combining Pembrolizumab (a drug that helps the immune system fight cancer) and Cesium-131 Brachytherapy (a type of targeted internal radiation therapy) along with salvage surgery to remove recurrent throat cancer.

What are the potential side effects?

Pembrolizumab may cause immune-related reactions affecting various organs, fatigue, skin rash, and infusion reactions. Cesium-131 might lead to localized pain, swelling at the treatment site, and typical risks associated with radiation.

Eligibility Criteria

Inclusion Criteria

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

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My head or neck cancer has returned and I can undergo another surgery.

Select...

My tumor can be surgically removed.

Exclusion Criteria

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

Select...

My surgery involves working around or replacing a major neck artery.

Select...

I have an active throat and skin condition.

Select...

My cancer has spread to more than one distant location.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 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

Disease-free survival

Overall Safety measured by dose limiting toxicities (DLTs).

Secondary study objectives

Adverse events

Loco-regional control rate

Overall Survival

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

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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 & Cesium-131Experimental Treatment2 Interventions

200 mg Pembrolizumab (Day -14 pre-surgery; Every 3 weeks after surgery) + Cesium-131 Seeds to deliver 60-70Gy of radiation (Single dose at the time of salvage surgery)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

FDA approved

Cesium-131

2015

Completed Early Phase 1

~30

0 / 5Eligibility criteria met