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Alkylating agents

Pembrolizumab + Radiation vs Chemotherapy + Radiation for Head and Neck Cancer

Phase 2

Recruiting

Led By Dan P Zandberg

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patient must not have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed

Patient must have had prior radiation to the area of recurrent or second primary tumor. This is defined as > 50% of the presurgical tumor volume having previously received a dose of > 45 Gy as determined by the treating radiation oncologist

Must not have

Patient must not have a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as HCV ribonucleic acid [RNA] [qualitative] is detected) infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years from date of registration

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing pembrolizumab, a monoclonal antibody, in combination with radiation therapy or pembrolizumab alone compared to the usual approach of chemotherapy plus radiation therapy after surgery in treating patients with head and neck squamous cell carcinoma that has come back or patients with a second head and neck cancer that is not from metastasis.

Who is the study for?

Adults aged 18-79 with recurrent or second primary head and neck squamous cell carcinoma, who've had surgery and prior radiation, can join this trial. They must have no distant disease spread, a specific protein (PD-L1) score >=1, and proper organ function. Those with severe allergies to pembrolizumab, active infections requiring systemic treatment, recent live vaccines, certain heart conditions or transplants are excluded.

What is being tested?

The trial is testing the effectiveness of pembrolizumab alone versus the usual treatment of chemotherapy combined with radiation after surgery for patients with head and neck cancer that has returned. Pembrolizumab is an immunotherapy drug designed to boost the body's immune response against cancer cells.

What are the potential side effects?

Pembrolizumab may cause immune-related side effects such as inflammation in various organs including lungs (pneumonitis), liver issues (hepatitis), skin reactions (rash), hormone gland problems (thyroid disorders), infusion reactions; whereas chemotherapy can cause nausea, hair loss, fatigue and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

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

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I haven't had any live vaccines in the last 30 days.

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My tumor area previously received high-dose radiation.

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I haven't needed steroids for lung inflammation in the last 3 years.

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I am between 18 and 79 years old.

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My cancer has spread beyond the original tumor site.

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My cancer cells are found right at or very close to the edge of the removed tissue.

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My cancer has returned in the head or neck area where I was previously treated with radiation.

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My recent scans show no signs of cancer spread.

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My heart is healthy enough for treatment, not classified as NYHA class III or IV.

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My tumor's PD-L1 score is 1 or higher, tested in a certified lab.

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I am fully active or can carry out light work.

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I do not have an infection that needs treatment through my body.

Exclusion Criteria

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

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I do not have hepatitis B or active hepatitis C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years from date of registration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years from date of registration

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

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of adverse events

Overall survival (OS)

Secondary study objectives

PD-L1 expression

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

Active Control

Group I: Arm C (pembrolizumab)Experimental Treatment3 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 6 weeks for 9 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI throughout the trial.

Group II: Arm B (cisplatin, carboplatin, IMRT, PBRT)Active Control6 Interventions

Patients receive cisplatin or carboplatin IV on day 1. Treatment repeats every 7 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo IMRT or PBRT QD for a total of 30 fractions in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2740

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160