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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.
Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 180 days after the last dose of study therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~92 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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I agree to use birth control during and up to 6 months after the study.
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My doctor agrees I can have the main surgery for my condition.
Select...
I agree not to donate sperm during and up to 6 months after the study.
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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 am fully active or restricted in physically strenuous activity but can do light work.
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I have provided a recent biopsy of a tumor that has not been treated with radiation.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event-free Survival (EFS)
Secondary outcome measures
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 • NCT0257868050%
Nausea
44%
Anaemia
38%
Fatigue
32%
Constipation
30%
Decreased appetite
28%
Cough
24%
Asthenia
24%
Neutropenia
23%
Dyspnoea
21%
Vomiting
20%
Diarrhoea
13%
Oedema peripheral
13%
Pyrexia
12%
Thrombocytopenia
11%
Back pain
11%
Rash
11%
Lacrimation increased
10%
Pruritus
9%
Headache
9%
Dizziness
9%
Dry skin
9%
Dysgeusia
8%
Alanine aminotransferase increased
8%
Arthralgia
8%
Musculoskeletal pain
8%
Conjunctivitis
8%
Pain in extremity
8%
Blood creatinine increased
8%
Pneumonia
7%
Haemoptysis
7%
Stomatitis
7%
Weight decreased
7%
Hypokalaemia
7%
Upper respiratory tract infection
7%
Mucosal inflammation
7%
Insomnia
6%
Leukopenia
6%
Aspartate aminotransferase increased
6%
White blood cell count decreased
6%
Paraesthesia
5%
Urinary tract infection
5%
Chest pain
5%
Nasopharyngitis
5%
Productive cough
5%
Abdominal pain
5%
Dyspepsia
4%
Rhinorrhoea
4%
Alopecia
4%
Hypomagnesaemia
3%
Hyperglycaemia
3%
Epistaxis
2%
Hypophosphataemia
2%
Oropharyngeal pain
2%
Pulmonary embolism
2%
Pneumonitis
2%
Febrile neutropenia
2%
Hypothyroidism
2%
Erythema
2%
Pleural effusion
1%
Lower respiratory tract infection
1%
Bronchitis
1%
General physical health deterioration
1%
Atrial flutter
1%
Sepsis
1%
Dehydration
1%
Deep vein thrombosis
1%
Syncope
1%
Malaise
1%
Hyponatraemia
1%
Abdominal pain upper
1%
Renal failure
1%
Chronic obstructive pulmonary disease
1%
Pancytopenia
1%
Cancer pain
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control
Pembrolizumab
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
4,581,118 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,053,867 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,062,776 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the history of Pembrolizumab 200 mg in medical research?
"The first study involving pembrolizumab 200 mg was conducted at City of Hope Comprehensive Cancer Center in 1997. As of now, there have been 1158 completed studies and 1619 ongoing trials. A large number these clinical trials are based in Pittsburgh, Pennsylvania."
Answered by AI
The FDA has greenlit Pembrolizumab 200 mg, correct?
"Pembrolizumab 200 mg is considered safe because it has passed Phase 3 clinical trials. This means that not only does the medication show some efficacy, but also that there are multiple rounds of data supporting its safety."
Answered by AI
In how many distinct locations is this clinical trial running?
"Presently, 44 medical facilities are recruiting patients for this study with locations such as Pittsburgh, Sioux Falls and Bethlehem. It would be advantageous to choose the clinical trial site nearest you to limit travel time if enrolled."
Answered by AI
Are patients still being recruited for this research project?
"Yes, this information can be found on the website clinicaltrials.gov. The trial was created on December 17th, 2018 and has been updated as recently as November 7th, 2020."
Answered by AI
How many test subjects are participating in this experiment?
"Yes, this is an ongoing study that is recruiting patients from 44 different sites. According to the listing on clinicaltrials.gov, 704 people are needed for the trial. The dates you provided are accurate - it was posted on 12/17/2018 and last updated on 11/7/2022."
Answered by AI
What goals does this research hope to achieve?
"According to the sponsor of this clinical trial, Merck Sharp & Dohme Corp., the primary outcome being measured over a period of up to 5 years is Major Pathological Response (mPR). In addition to measuring the primary outcome, this trial will also be measuring secondary outcomes including Percentage of Participants Experiencing An Adverse Event (AEs), which is defined as the percentage of participants experiencing any sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy. Anothersecondary outcome being measured is Pathological Complete Response (pCR), which is defined"
Answered by AI
What are the standard conditions that Pembrolizumab 200 mg is used to address?
"Pembrolizumab 200 mg is the standard care medication for treating malignant neoplasms. However, this immunotherapy can also be useful in other cases such as unresectable melanoma, microsatellite instability high, and instances where there is a high risk of recurrence."
Answered by AI
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