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Monoclonal Antibodies

Immunotherapy + Radiation + Surgery for Head and Neck Cancer

Phase 1

Recruiting

Led By Dukagjin M Blakaj, MD, PhD

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Pathologically confirmed either persistent and/ or locoregionally recurrent HNSCC of oral cavity, pharynx, larynx, unknown primary head and neck (H&N) squamous cell carcinoma

Patients who plan to or have undergone therapy for their cancer, such as surgery and/or chemotherapy and/or radiotherapy and recurred

Must not have

Subjects with history of grade 3 toxicity with prior immunotherapy

Salivary gland carcinomas, lip carcinoma, adenocarcinoma of the skin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is to find out the possible side effects of pembrolizumab and radiation therapy before and during surgery in treating patients with head and neck squamous cell cancer.

Who is the study for?

This trial is for adults with certain types of head and neck cancers that are treatable by surgery but have persisted or returned after treatment. Participants must be in good health with proper organ function, not pregnant, and willing to use contraception. They should not have other recent cancers, HIV, hepatitis B or C, severe autoimmune diseases, untreated brain metastases, a history of severe immunotherapy side effects, or be on current immunosuppressive drugs.

What is being tested?

The study tests the effectiveness of pembrolizumab (an immune system-boosting drug) combined with radiation therapy before and during cancer surgery. The goal is to see if this combination helps reduce tumor size more effectively than previous treatments for persistent or recurrent head and neck squamous cell carcinoma.

What are the potential side effects?

Possible side effects include reactions related to the immune system such as inflammation in various organs; fatigue; skin reactions; potential complications from radiation like skin burns; surgical risks like infection; plus any typical side effects from pembrolizumab including fever and chills.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is a confirmed case of head and neck squamous cell carcinoma.

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My cancer came back after treatment like surgery, chemo, or radiation.

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I am 18 years old or older.

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I can do most activities without help.

Exclusion Criteria

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

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I had a severe reaction to previous immunotherapy.

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My cancer is in the salivary glands, lips, or skin.

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I have previously used immune checkpoint inhibitors.

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I have tested positive for HIV, hepatitis B, or hepatitis C.

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I have brain metastases that have not been treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

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

Health related quality of life

Incidence of adverse events

Secondary study objectives

Local control rate

Objective-response rate (ORR)

Overall survival

+2 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

3Treatment groups

Experimental Treatment

Group I: Arm C (pembrolizumab, EBRT, salvage surgery, IORT)Experimental Treatment5 Interventions

Patients receive pembrolizumab IV on day 1 of week 1, and undergo high dose EBRT for 2 fractions on 2 consecutive days during week 4. Patients also undergo salvage surgery during week 8. Beginning week 11, patients receive pembrolizumab IV every 3 weeks for up to 18 doses in the absence of disease progression or unacceptable toxicity. Patients also undergo IORT for 1 fraction during week 11. Treatment with pembrolizumab may continue beyond initial progression per investigator-assessed clinical benefit and if the patient is tolerating pembrolizumab.

Group II: Arm B (pembrolizumab, EBRT, salvage surgery, IORT)Experimental Treatment5 Interventions

Patients receive pembrolizumab IV on day 1 of week 1, and undergo low dose EBRT for 2 fractions on 2 consecutive days during week 4. Patients also undergo salvage surgery during week 8. Beginning week 11, patients receive pembrolizumab IV every 3 weeks for up to 18 doses in the absence of disease progression or unacceptable toxicity. Patients also undergo IORT for 1 fraction during week 11. Treatment with pembrolizumab may continue beyond initial progression per investigator-assessed clinical benefit and if the patient is tolerating pembrolizumab.

Group III: Arm A (pembrolizumab, salvage surgery, IORT)Experimental Treatment4 Interventions

Patients receive pembrolizumab IV on day 1 of week 1, and undergo salvage surgery during week 4. Beginning week 8, patients receive pembrolizumab IV every 3 weeks for up to 18 doses in the absence of disease progression or unacceptable toxicity. Patients also undergo IORT for 1 fraction during week 9. Treatment with pembrolizumab may continue beyond initial progression per investigator-assessed clinical benefit and if the patient is tolerating pembrolizumab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

External Beam Radiation Therapy

2006

Completed Phase 3

~3300

Intraoperative Radiation Therapy

2012

N/A

~500