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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

Must not have

Uncontrolled intercurrent illness

Prior treatment for head and neck cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the time of surgery (surgery occurred within 13-22 days after last neoadjuvant mk-3475 dose)

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

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

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I do not have any unmanaged ongoing illnesses.

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I have received treatment for head and neck cancer before.

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I have cancer in my nasal passages or sinuses.

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I have previously been treated with specific antibodies or drugs.

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I have an immune system disorder or take more than 10 mg of steroids daily.

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I am not currently in any clinical trials nor have I been in one within the last 4 weeks.

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I have been treated for an autoimmune disease in the last 2 years.

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I have had pneumonitis treated with steroids or have it now.

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I have an active tuberculosis infection.

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I have a history of hepatitis B or an active hepatitis C infection.

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I have been diagnosed with HIV.

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My throat cancer is HPV or p16 positive.

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I have metastatic neck cancer from an unknown primary source.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the time of surgery (surgery occurred within 13-22 days after neoadjuvant mk-3475 dose)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the time of surgery (surgery occurred within 13-22 days after neoadjuvant mk-3475 dose)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the time of surgery (surgery occurred within 13-22 days after neoadjuvant mk-3475 dose) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Distant Failure Rate in Cohorts 1 and 2

Locoregional Recurrence Rates in Cohorts 1 and 2

Rate of Major Pathologic Treatment Effect in Cohort 1

+1 more

Secondary study objectives

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

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%

Headache

19%

Neutropenia

19%

Neuropathy peripheral

17%

Constipation

16%

COVID-19

16%

Neutrophil count decreased

15%

Arthralgia

14%

Rash

13%

Decreased appetite

13%

Hypothyroidism

12%

White blood cell count decreased

12%

Hyperglycaemia

12%

Radiation skin injury

11%

Myalgia

11%

Lymphopenia

Epistaxis

Urinary tract infection

Hypertension

Cough

Infusion related reaction

Pruritus

Pyrexia

Blood alkaline phosphatase increased

Dysgeusia

Dizziness

Hot flush

Dyspepsia

Hypersensitivity

Abdominal pain upper

Mucosal inflammation

Paraesthesia

Illness

Peripheral sensory neuropathy

Insomnia

Back pain

Hyperthyroidism

Pain in extremity

Leukopenia

Blood lactate dehydrogenase increased

Weight decreased

Anxiety

Folliculitis

Oedema peripheral

Adrenal insufficiency

Blood thyroid stimulating hormone increased

Dry mouth

Pain

Abdominal pain

Dry eye

Lymphocyte count decreased

Hypokalaemia

Hyponatraemia

Nasopharyngitis

Dyspnoea

Lacrimation increased

Gastrooesophageal reflux disease

Blood thyroid stimulating hormone decreased

Stomatitis

Rash maculo-papular

Onycholysis

Pulmonary embolism

Palpitations

Breast pain

Depression

COVID-19 pneumonia

Dry skin

Procedural pain

Tachycardia

Febrile neutropenia

Bone pain

Postoperative wound infection

Thrombocytopenia

Malignant neoplasm progression

Oropharyngeal pain

Nail disorder

Arterial thrombosis

Thyroiditis subacute

Pemphigoid

Embolism

Hypotension

Diabetic ketoacidosis

Chills

Colitis

Cardio-respiratory arrest

Myocardial infarction

Cervix carcinoma

Upper respiratory tract infection

Infection

Glomerulonephritis

Vertigo

Cardiac perfusion defect

Myelosuppression

Hepatitis cholestatic

Myocarditis

Pneumonia bacterial

Left ventricular failure

Immune-mediated adrenal insufficiency

Interstitial lung disease

Anaphylactic reaction

Intracranial pressure increased

Cardiac failure

Pneumonia

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

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

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

~2490

Intensity modulated radiation therapy

2003

Completed Phase 2

~140