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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 belowSelect...
My oropharyngeal cancer has been tested for HPV status.
Select...
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.
Select...
My cancer can be measured by scans.
Select...
I am not pregnant or breastfeeding.
Select...
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:Select...
I have been treated for an autoimmune disease in the last 2 years.
Select...
I am highly allergic to pembrolizumab, radiotherapy, cisplatin, or similar treatments.
Select...
I have severe bleeding caused by my cancer.
Select...
I have or am currently positive for Hepatitis B or C.
Select...
I have had a transplant from another person.
Select...
My head or neck cancer is at an advanced stage with significant spread.
Select...
I have been treated with drugs targeting immune checkpoints.
Select...
I have or had lung inflammation treated with steroids.
Select...
I am not pregnant, as confirmed by a recent test.
Select...
I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.
Select...
My cancer is not in my mouth or throat but in areas like my nose or sinuses.
Select...
I have detectable brain or spinal cord cancer spread, treated or not.
Select...
I have moderate to severe hearing loss.
Select...
I am currently being treated for an infection.
Select...
I have been diagnosed with HIV.
Select...
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
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 moreSide effects data
From 2023 Phase 3 trial • 616 Patients • NCT0257868020%
Decreased appetite
19%
Nausea
18%
Dyspnoea
14%
Vomiting
13%
Diarrhoea
13%
Oedema peripheral
12%
Arthralgia
11%
Cough
10%
Fatigue
8%
Abdominal pain
8%
Constipation
8%
Back pain
7%
Anaemia
7%
Hypothyroidism
7%
Asthenia
7%
Chest pain
7%
Pyrexia
7%
Pain in extremity
6%
Nasopharyngitis
6%
Hypertension
6%
Aspartate aminotransferase increased
6%
Headache
5%
Blood creatinine increased
5%
Neck pain
5%
Urinary tract infection
5%
Weight decreased
5%
Pneumonia
5%
Alanine aminotransferase increased
5%
Pruritus
5%
Rash
4%
Pulmonary embolism
4%
Productive cough
4%
Erythema
2%
Herpes zoster
2%
Dry eye
2%
Bronchitis
2%
Gastrooesophageal reflux disease
2%
Sinusitis
2%
Blood alkaline phosphatase increased
2%
Hyperglycaemia
2%
Hypokalaemia
2%
Musculoskeletal chest pain
2%
Dizziness
2%
Haemoptysis
1%
Vertigo
1%
Pain
1%
Upper respiratory tract infection
1%
Hypercalcaemia
1%
Atrial flutter
1%
Pericardial effusion
1%
Autoimmune hepatitis
1%
Gastroenteritis
1%
Respiratory syncytial virus infection
1%
Type 1 diabetes mellitus
1%
Pneumonitis
1%
Hypophosphataemia
1%
Musculoskeletal pain
1%
Wheezing
1%
Dry skin
1%
Febrile neutropenia
1%
Colitis ulcerative
1%
Gastrointestinal toxicity
1%
Stomatitis
1%
Inflammation
1%
Endocarditis
1%
Influenza
1%
Parotitis
1%
Sepsis
1%
Intracranial aneurysm
1%
Atelectasis
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Pulmonary haemorrhage
1%
Deep vein thrombosis
1%
Thrombocytopenia
1%
Lacrimation increased
1%
Dyspepsia
1%
Mucosal inflammation
1%
Dysgeusia
1%
Paraesthesia
1%
Insomnia
1%
Oropharyngeal pain
1%
Rhinorrhoea
1%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control Switched Over to Pembrolizumab Monotherapy
Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed (Second Course)
Control Switched Over to Pembrolizumab Monotherapy (Second Course)
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
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,495 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
4,010 Previous Clinical Trials
5,184,513 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,885 Previous Clinical Trials
8,088,058 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated for an autoimmune disease in the last 2 years.My oropharyngeal cancer has been tested for HPV status.I am highly allergic to pembrolizumab, radiotherapy, cisplatin, or similar treatments.I have severe bleeding caused by my cancer.I agree to use birth control during and up to 6 months after the study.I have not received a live vaccine in the last 30 days.My doctor agrees I can have the main surgery for my condition.I have or am currently positive for Hepatitis B or C.I agree not to donate sperm during and up to 6 months after the study.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.I have had previous cancer treatments, including radiotherapy or drugs, for my head and neck cancer.I have had a transplant from another person.My head or neck cancer is at an advanced stage with significant spread.I have been treated with drugs targeting immune checkpoints.My cancer can be measured by scans.I am not pregnant or breastfeeding.I have not fully recovered from major surgery or its complications.I have or had lung inflammation treated with steroids.I am not pregnant, as confirmed by a recent test.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.You have recently taken part in a study testing a new drug or device within the past month.I am fully active or restricted in physically strenuous activity but can do light work.My cancer is not in my mouth or throat but in areas like my nose or sinuses.I have detectable brain or spinal cord cancer spread, treated or not.I have moderate to severe hearing loss.I have not had active treatment for another cancer, except for certain skin cancers or in situ cancers, in the last 3 years.I am currently being treated for an infection.I have been diagnosed with HIV.I experience significant numbness or pain in my hands or feet.I have provided a recent biopsy of a tumor that has not been treated with radiation.
Research Study Groups:
This trial has the following groups:- Group 1: Pembro Neoadjuvant+Pembro SOC Adjuvant
- Group 2: No Neoadjuvant+SOC Adjuvant
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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