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Pembrolizumab for Head and Neck Cancers

Phase 2
Waitlist Available
Led By Tanguy Seiwert, M.D.
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have histologically confirmed head and neck cancer (Squamous cell histology as well as HPV+ and/or EBV+ head and neck tumors), Stages IVA, IVB, and select cases of Stage III.
Completed curative intent therapy, without additional standard of care curative intent therapy feasible within 20 weeks prior to study enrollment
Must not have
Known history of Human Immunodeficiency Virus (HIV) or active Hepatitis B or Hepatitis C
Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years

Summary

This trial is testing whether adding the immunotherapy drug pembrolizumab to standard treatment can help people with squamous cell carcinoma of the head and neck who are at high risk for the cancer coming back.

Who is the study for?
Adults with head and neck squamous cell carcinoma who've finished curative treatment within the last 20 weeks, at high risk of cancer coming back. They must have good performance status, agree to use contraception, and not be pregnant or breastfeeding. Excluded are those with active infections like TB or hepatitis, recent other treatments or trials, certain autoimmune diseases, another progressing cancer, CNS metastases, or a history of severe reactions to pembrolizumab.
What is being tested?
The PATHWay Study is testing if pembrolizumab can prevent cancer from returning in patients with high-risk head and neck cancers after they've completed their main treatment. Participants will either receive pembrolizumab or a placebo for one year in this double-blind study where neither doctors nor patients know who's getting the real drug.
What are the potential side effects?
Pembrolizumab may cause immune system-related side effects such as inflammation in various organs including lungs (pneumonitis), liver problems (hepatitis), skin rash, hormone gland issues (like thyroid dysfunction), infusion reactions during administration of the drug and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is in the head or neck area, confirmed by tests, and is at a specific advanced stage.
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I finished my cancer treatment aimed at curing it and can't have more of such treatments for the next 20 weeks.
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I am at least 18 years old.
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My throat cancer's HPV status is known before treatment starts.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of HIV or active Hepatitis B/C.
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I haven't taken steroids or immunosuppressants in the last 7 days.
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I have an active tuberculosis infection.
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I haven't had cancer treatment or recovered from its side effects in the last 2 weeks.
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I have cancer that has spread to my brain or spinal cord.
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I have been treated for an autoimmune disease in the last 2 years.
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I have or had lung inflammation not caused by an infection.
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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.
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I have not received a live vaccine in the last 30 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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
Secondary study objectives
Progression free survival in gene expression profile (GEP) positive patients
Progression free survival in gene expression profile in PD-L1 >10% positive patients

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
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab

Trial Design

2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
iv, every 3 weeks, x 1 year
Group II: PembrolizumabExperimental Treatment1 Intervention
200mg, every three weeks, iv, x 1 year
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Pembrolizumab
2017
Completed Phase 3
~2810

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,054 Previous Clinical Trials
759,859 Total Patients Enrolled
Tanguy Seiwert, M.D.Principal InvestigatorUniversity of Chicago
5 Previous Clinical Trials
143 Total Patients Enrolled
Alexander Pearson, M.D.Principal InvestigatorUniversity of Chicago

Media Library

Pembrolizumab Clinical Trial Eligibility Overview. Trial Name: NCT02841748 — Phase 2
Head and Neck Cancers Research Study Groups: Pembrolizumab, Placebo
Head and Neck Cancers Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT02841748 — Phase 2
Pembrolizumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT02841748 — Phase 2
~6 spots leftby Jun 2025
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