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Pembrolizumab + Chemoradiation 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 provided tissue for Programmed Cell Death Receptor Ligand 1 (PD-L1) biomarker analysis from a core or excisional biopsy
Has a pathologically proven new diagnosis of oropharyngeal p16 positive, oropharyngeal p16 negative, or larynx/hypopharynx/oral cavity squamous cell carcinoma (independent of p16)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 62 months
Awards & highlights
Study Summary
This trial is testing whether pembrolizumab, given with standard chemoradiation, can help people with head and neck squamous cell carcinoma live longer cancer-free.
Who is the study for?
This trial is for adults with a new diagnosis of certain types of head and neck squamous cell carcinoma that can't be removed by surgery. They must have measurable disease, not had previous cancer treatments or major surgeries recently, no active infections like Hepatitis B/C or HIV, and agree to use contraception. Those with autoimmune diseases requiring recent treatment or a history of severe reactions to the drugs being tested cannot join.Check my eligibility
What is being tested?
The study tests if pembrolizumab (a drug that helps the immune system fight cancer) combined with chemoradiation therapy works better than a placebo plus chemoradiation in treating locally advanced head and neck cancer. The main goal is to see if patients live longer without their disease getting worse when given pembrolizumab.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in organs like lungs (pneumonitis), liver, intestines, hormone glands, kidneys; skin rash; infusion reactions; fatigue; flu-like symptoms; and increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have given a tissue sample for PD-L1 testing.
Select...
I have a new diagnosis of throat or mouth cancer, regardless of p16 status.
Select...
My oral cavity cancer cannot be removed with surgery.
Select...
My cancer's size can be measured with a CT scan or MRI.
Select...
I am eligible for chemoradiotherapy instead of surgery, as decided by my doctor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 62 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 62 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/Quality of Life (GHS/QoL)
Change From Baseline in Physical Functioning
Change From Baseline in Swallowing, Speech, and Pain Symptoms
+3 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pembrolizumab + Cisplatin + CRTExperimental Treatment4 Interventions
Participants receive a priming dose of pembrolizumab before initiation of CRT (either accelerated or standard fractionation radiotherapy regimen). During CRT, participants receive 2 doses of pembrolizumab and up to 3 cycles of Cisplatin (2 cycles during accelerated and 3 cycles during standard fractionation radiotherapy). Participants also receive up to an additional 14 cycles of pembrolizumab alone as maintenance therapy for a total of 17 cycles of pembrolizumab. If cisplatin and/or radiation therapy is discontinued, the participant may continue on treatment with pembrolizumab.
Group II: Placebo + Cisplatin + CRTPlacebo Group4 Interventions
Participants receive placebo before initiation of CRT (either accelerated or standard fractionation radiotherapy regimen). During CRT, participants receive 2 doses of placebo and up to 3 cycles of Cisplatin (2 cycles during accelerated and 3 cycles during standard fractionation radiotherapy). Participants also receive up to an additional 14 cycles of placebo alone for a total of 17 cycles of placebo. If cisplatin and/or radiation therapy is discontinued, the participant may continue on treatment with placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Cisplatin
2013
Completed Phase 3
~1940
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,018 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,884 Previous Clinical Trials
5,053,581 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,062,676 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have given a tissue sample for PD-L1 testing.I have been treated with drugs targeting immune checkpoints or participated in pembrolizumab studies.My cancer is not located in the throat or mouth.I have received treatments like chemotherapy, targeted therapy, radiation, or major surgery for my head and neck cancer.I am still recovering from a major surgery.I have not received a live vaccine in the last 30 days.I have an active Hepatitis B or C infection.I have been diagnosed with HIV.I have been treated for an autoimmune disease in the last 2 years.I am fully active or restricted in physically strenuous activity but can do light work.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I have had pneumonitis treated with steroids or have it now.I am currently being treated for an infection.I agree to use birth control during and up to 6 months after the study.I have a new diagnosis of throat or mouth cancer, regardless of p16 status.My oral cavity cancer cannot be removed with surgery.My cancer's size can be measured with a CT scan or MRI.I have been in remission from cancer for at least 5 years.I am eligible for chemoradiotherapy instead of surgery, as decided by my doctor.I am a woman who can have children and have a recent negative pregnancy test.I have cancer that has spread to my brain or spinal cord.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab + Cisplatin + CRT
- Group 2: Placebo + Cisplatin + CRT
Awards:
This trial has 1 awards, including:- 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.
To what extent has Pembrolizumab been clinically tested in the past?
"Pembrolizumab is being trialed in 1618 different ongoing studies, with the majority of those in Phase 3. The drug is being tested across 70055 locations, with the largest concentration of trials taking place in Shanghai, China."
Answered by AI
Are we still able to enroll in this clinical research?
"No, this particular study is not currently looking for patients, as indicated on clinicaltrials.gov. This study was originally posted on April 5th, 2017 and was last edited on June 30th, 2022. There are, however, 4,650 other trials that are presently looking for patients."
Answered by AI
If a patient were interested in enrolling in this trial, how many different places could they potentially go to?
"A few of the 32 locations where this clinical trial is taking place are Willamette Valley Cancer Institute and Research Center ( Site 8000) in Eugene, Oregon, Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center ( Site 0290) in Springfield, Missouri, and Oncology Hematology Care, Inc. ( Site 8003) in Cincinnati, Ohio."
Answered by AI
How many people are being treated as part of this clinical research?
"As of right now, this particular clinical trial is not recruiting any more patients. This information is reflected in the trial's posting date (4/5/2017) as well as its last edit date (6/30/2022). However, there are many other trials that are presently looking for patients. For example, there are 3032 trials for head neoplasms and 1618 trials for Pembrolizumab that are still open for recruitment."
Answered by AI
Has Pembrolizumab been cleared by the FDA?
"Pembrolizumab has received a score of 3 for safety. This is due to this being a Phase 3 trial, which means there is both evidence of efficacy and multiple rounds of data supporting safety."
Answered by AI
What are Pembrolizumab's most common indications?
"Pembrolizumab is the standard care for patients with malignant neoplasms. However, this medication can also target other conditions, like unresectable melanoma, microsatellite instability high, and high risk of recurrence."
Answered by AI
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