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PD-1 Inhibitor

Pembrolizumab + Radiotherapy for Head and Neck Cancer

Phase 3

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

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

Must have

Has results from testing of HPV status for oropharyngeal cancer defined as p16.

Has histologically confirmed new diagnosis of resectable, non-metastatic, squamous cell carcinoma that is either: Stage III Human Papillomavirus (HPV) positive oropharyngeal primary that is tumor size (T) 4, lymph node involvement (N) 0-2, no distant metastases (M0); Stage III or IVA oropharyngeal HPV negative; or Stage III or IVA larynx/hypopharynx/oral cavity primaries.

Must not have

Has an active autoimmune disease that has required systemic treatment in past 2 years.

Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients, radiotherapy, cisplatin or their analogs.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~92 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing whether adding pembrolizumab to radiotherapy (with or without cisplatin) before and after surgery improves outcomes in people with newly diagnosed, resectable head and neck squamous cell carcinoma.

Who is the study for?

This trial is for adults with newly diagnosed, resectable Stage III/IVA head and neck squamous cell carcinoma. Participants must not be pregnant or breastfeeding, agree to use contraception, have no prior anti-PD-1/L1/L2 therapy or cancer treatment, no live vaccines in the last 30 days, and no immunosuppressive conditions.

What is being tested?

The study tests pembrolizumab given before surgery and combined with post-surgery radiotherapy (with or without cisplatin) against standard care. It aims to see if this improves event-free survival in patients whose tumors express a protein called PD-L1.

What are the potential side effects?

Pembrolizumab may cause immune-related side effects like inflammation of organs, infusion reactions, fatigue; Cisplatin can lead to hearing loss, nerve damage; Radiotherapy might result in skin irritation and fatigue.

Eligibility Criteria

Inclusion Criteria

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

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My oropharyngeal cancer has been tested for HPV status.

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My cancer is a specific type of throat or mouth cancer that can be surgically removed and has not spread to distant parts of my body.

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My cancer can be measured by scans.

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I am not pregnant or breastfeeding.

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I have provided a recent biopsy of a tumor that has not been treated with radiation.

Exclusion Criteria

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

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

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I am highly allergic to pembrolizumab, radiotherapy, cisplatin, or similar treatments.

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I have severe bleeding caused by my cancer.

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I have or am currently positive for Hepatitis B or C.

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I have had a transplant from another person.

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My head or neck cancer is at an advanced stage with significant spread.

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I have been treated with drugs targeting immune checkpoints.

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I have or had lung inflammation treated with steroids.

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I am not pregnant, as confirmed by a recent test.

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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

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My cancer is not in my mouth or throat but in areas like my nose or sinuses.

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I have detectable brain or spinal cord cancer spread, treated or not.

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I have moderate to severe hearing loss.

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I am currently being treated for an infection.

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I have been diagnosed with HIV.

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I experience significant numbness or pain in my hands or feet.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~92 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~92 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~92 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Event-free Survival (EFS)

Secondary study objectives

Change From Baseline in Global Health Status/Physical Functioning Scales

Change From Baseline in Global Health Status/Quality of Life Scale (GHS/QoL)

Change from Baseline in Swallowing, Speech, and Pain Symptoms

+5 more

Side effects data

From 2023 Phase 3 trial • 616 Patients • NCT02578680

22%

Infective exacerbation of chronic obstructive airways disease

22%

Abdominal pain

22%

Diarrhoea

22%

Nasopharyngitis

22%

Proteinuria

22%

Cough

22%

Hypertension

11%

Otorrhoea

11%

Skin abrasion

11%

Wheezing

11%

Upper respiratory tract infection

11%

Ear infection

11%

Contusion

11%

Herpes zoster

11%

Nausea

11%

Gastrooesophageal reflux disease

11%

Tri-iodothyronine increased

11%

Rhinorrhoea

11%

Vomiting

11%

Hypomagnesaemia

11%

Arthralgia

11%

Sinusitis

11%

Ear discomfort

11%

Vertigo

11%

Skin ulcer

11%

Fall

11%

Fatigue

11%

Otitis externa

11%

Blood alkaline phosphatase increased

11%

Blood magnesium decreased

11%

Musculoskeletal chest pain

11%

Neck pain

11%

Pain in extremity

11%

Radiculopathy

11%

Insomnia

11%

Dyspnoea

11%

Productive cough

11%

Dry skin

11%

Pruritus

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed (Second Course)

Control Switched Over to Pembrolizumab Monotherapy (Second Course)

Control Switched Over to Pembrolizumab Monotherapy

Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed

Control

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pembro Neoadjuvant+Pembro SOC AdjuvantExperimental Treatment5 Interventions

Participants receive 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles as a neoadjuvant prior to surgery. Following surgical resection, high risk participants receive 200 mg pembrolizumab by IV infusion administered on Day 1 every 3 weeks (Q3W) for fifteen 21-day cycles plus standard of care radiotherapy plus cisplatin 100 mg/m\^2 by IV infusion on Day 1 Q3W for three 21-day cycles as adjuvant therapy. Following surgical resection, low risk participants receive 200 mg pembrolizumab by IV infusion administered on Day 1 Q3W for fifteen 21-day cycles plus standard of care radiotherapy as adjuvant therapy.

Group II: No Neoadjuvant+SOC AdjuvantActive Control4 Interventions

Participants receive no neoadjuvant prior to surgery. Following surgical resection, high risk participants receive standard of care radiotherapy plus cisplatin 100 mg/m\^2 by IV infusion on Day 1 Q3W for three 21-day cycles as adjuvant therapy. Following surgical resection, low risk participants receive standard of care radiotherapy as adjuvant therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab 200 mg

2013

Completed Phase 3

~930

0 / 21Eligibility criteria met