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Platinum-containing Compound

Immunotherapy for Head and Neck Cancer

Phase 2

Waitlist Available

Led By Douglas R Adkins, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically confirmed stage III or IV HNSCC oral cavity, hypopharynx, oropharynx, larynx (excluding p16 or HPV-positive oropharynx primaries and sinonasal primaries)

At least 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the time of surgery (approximately 2-3 weeks after registration)

Awards & highlights

Study Summary

This trial is testing a new drug to see if it can improve survival rates for people with head and neck cancer.

Who is the study for?

Adults with stage III or IV head and neck squamous cell carcinoma (excluding HPV-positive types) who are fit for surgery, have not had prior treatment for this cancer, and meet certain health criteria like normal organ function. Participants must be willing to use two forms of contraception during the study.Check my eligibility

What is being tested?

The trial is testing MK-3475 (pembrolizumab), given before and after surgery, along with standard treatments including radiation therapy and cisplatin chemotherapy. The aim is to see if pembrolizumab can reduce the risk of cancer returning or spreading in high-risk patients.See study design

What are the potential side effects?

Pembrolizumab may cause immune-related side effects such as inflammation in various organs, infusion reactions, fatigue, skin rash, digestive issues like diarrhea or colitis, liver problems, hormone gland problems (like thyroid disorders), and could potentially worsen pre-existing autoimmune diseases.

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 mouth, throat, or voice box and is not related to HPV.

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I am 18 years old or older.

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I am fully active and can carry on all pre-disease activities without restriction.

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I agree to use two forms of birth control.

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My blood tests for bone marrow and organ function are normal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the time of surgery (approximately 2-3 weeks after registration)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the time of surgery (approximately 2-3 weeks after registration)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the time of surgery (approximately 2-3 weeks after registration) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Distant Failure Rate in Cohorts 1 and 2

Rate of Major Pathologic Treatment Effect in Cohort 1

Rate of Major Pathologic Treatment Effect in Cohort 2

Secondary outcome measures

Locoregional Recurrence Rates in Cohorts 1 and 2

Number of Participants in Cohort 1 and 2 Who Experienced Reportable Adverse Events

Number of Surgical Complications and/or Delays in Cohorts 1 and 2

+1 more

Side effects data

From 2023 Phase 3 trial • 521 Patients • NCT04109066

65%

Alopecia

48%

Nausea

36%

Anaemia

26%

Fatigue

25%

Aspartate aminotransferase increased

24%

Diarrhoea

21%

Alanine aminotransferase increased

20%

Vomiting

20%

Asthenia

19%

Neuropathy peripheral

19%

Headache

19%

Neutropenia

17%

Constipation

16%

COVID-19

16%

Neutrophil count decreased

15%

Arthralgia

14%

Rash

13%

Decreased appetite

13%

Hypothyroidism

12%

Hyperglycaemia

12%

Radiation skin injury

12%

White blood cell count decreased

11%

Lymphopenia

11%

Myalgia

Cough

Pruritus

Infusion related reaction

Pyrexia

Urinary tract infection

Epistaxis

Hypertension

Blood alkaline phosphatase increased

Dizziness

Dyspepsia

Dysgeusia

Hot flush

Paraesthesia

Peripheral sensory neuropathy

Abdominal pain upper

Pain in extremity

Back pain

Illness

Mucosal inflammation

Leukopenia

Hypersensitivity

Hyperthyroidism

Insomnia

Blood lactate dehydrogenase increased

Weight decreased

Anxiety

Folliculitis

Abdominal pain

Blood thyroid stimulating hormone increased

Dry mouth

Adrenal insufficiency

Oedema peripheral

Pain

Blood thyroid stimulating hormone decreased

Hyponatraemia

Dyspnoea

Stomatitis

Dry eye

Lacrimation increased

Gastrooesophageal reflux disease

Nasopharyngitis

Lymphocyte count decreased

Hypokalaemia

Palpitations

Breast pain

Nail disorder

Postoperative wound infection

Bone pain

Onycholysis

Pulmonary embolism

Dry skin

Thrombocytopenia

Depression

Malignant neoplasm progression

Rash maculo-papular

Febrile neutropenia

COVID-19 pneumonia

Tachycardia

Procedural pain

Oropharyngeal pain

Myocarditis

Pneumonia bacterial

Pemphigoid

Embolism

Left ventricular failure

Thyroiditis subacute

Interstitial lung disease

Upper respiratory tract infection

Cardiac failure

Cardiac perfusion defect

Vertigo

Immune-mediated adrenal insufficiency

Cervix carcinoma

Hypotension

Chills

Pneumonia

Myelosuppression

Intracranial pressure increased

Cardio-respiratory arrest

Myocardial infarction

Colitis

Anaphylactic reaction

Diabetic ketoacidosis

Hepatitis cholestatic

Infection

Glomerulonephritis

Arterial thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Arm A: Nivo + Chemo (PTX QW + AC Q3W) / Nivo + ET

Arm A: Nivo + Chemo (PTX QW + AC Q2W) / Nivo + ET

Arm B: Nivo Placebo + Chemo (PTX QW + AC Q3W) / ET

Arm B: Nivo Placebo + Chemo (PTX QW + AC Q2W) / ET

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2: Neoadjuvant MK-3475Experimental Treatment6 Interventions

-MK-3475 will be given once intravenously and then given again 21 days after dose 1 (14-24 days before standard of care surgery)

Group II: Cohort 1: Neoadjuvant MK-3475 and Adjuvant MK-3475Experimental Treatment7 Interventions

MK-3475 will be given intravenously once approximately 2-3 weeks prior to standard of care surgery. Adjuvant therapy will be dictated by surgical pathology and occurs after standard of care surgery and will consist of: risk-based intensity modulated radiation therapy consisting of 60 Gy in 2 Gy once-daily fraction size (total of 30 fractions)once-daily fraction size (total of 30 fractions) optional image-guided radiation therapy risk-based cisplatin administered intravenously on Days 1, 22, and 43 of treatment course MK-3475 will be given intravenously once every 3 weeks for a maximum of 6 doses if participant is considered high-risk based surgical pathology from standard of care surgery. These doses of MK-3475 will be given after surgery and after all acute toxicities of post-operative standard of care chemotherapy and radiation have resolved to grade 1 or less.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Surgery

2000

Completed Phase 3

~2550

Intensity modulated radiation therapy

2003

Completed Phase 2

~140