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Alkylating agents
Immunotherapy + Radiation for Head and Neck Cancer
Phase 2
Recruiting
Research Sponsored by Loren Mell, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
High-Intermediate Risk Disease as defined by specific criteria
p16-positive squamous cell carcinoma of the pharynx, larynx or oral cavity
Must not have
Known history of Human Immunodeficiency Virus (HIV)
Known active Hepatitis B or Hepatitis C
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial is testing whether adding the immunotherapy drug pembrolizumab to standard radiation therapy improves outcomes for patients with head and neck squamous cell carcinoma.
Who is the study for?
This trial is for adults with certain high-risk head and neck cancers, including oropharynx, larynx, nasopharynx, and oral cavity squamous cell carcinoma. Participants must have no distant metastases, be HIV negative, not pregnant or breastfeeding, agree to use contraception during the study period and have adequate organ function.
What is being tested?
The trial compares pembrolizumab (an experimental immunotherapy drug) plus radiation therapy against the standard treatment of cisplatin chemotherapy plus radiation therapy in treating head and neck squamous cell carcinoma.
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in various organs, skin reactions, fatigue and infusion-related reactions. Cisplatin can lead to nausea/vomiting, kidney damage, hearing loss and nerve damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition is considered high-intermediate risk.
Select...
My cancer is p16-positive in the throat, voice box, or mouth.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with HIV.
Select...
I have an active Hepatitis B or C infection.
Select...
I have had radiation, chemotherapy, or immunotherapy for head and neck cancer.
Select...
I have been treated for an autoimmune disease in the last 2 years.
Select...
I have or had lung inflammation not caused by an infection.
Select...
I am currently being treated for an infection.
Select...
I have had major surgery to remove my cancer.
Select...
My cancer has spread to distant parts of my body.
Select...
I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
progression-free survival (PFS)
Secondary study objectives
Acute toxicity
Late toxicity
Patterns of failure
+1 moreOther study objectives
PD-L1 expression correlations
Side effects data
From 2024 Phase 3 trial • 804 Patients • NCT0304099964%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Systemic infection
1%
Clostridium difficile colitis
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental-Radiotherapy/pembrolizumabExperimental Treatment2 Interventions
Intensity-modulated radiation therapy to 70 Gy in 33-35 fractions over 6.5 weeks plus concurrent and adjuvant pembrolizumab 200 mg IV infusion every 3 weeks x 20 cycles
Group II: Control-radiotherapy/cisplatinActive Control2 Interventions
Intensity-modulated radiation therapy to 70 Gy in 33-35 fractions over 6.5 weeks plus concurrent cisplatin 100 mg/m2 every 3 weeks for 3 cycles (7 weeks)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Radiation therapy
2013
Completed Phase 3
~2850
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
4,015 Previous Clinical Trials
5,186,219 Total Patients Enrolled
Loren Mell, MDLead Sponsor
1 Previous Clinical Trials
42 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with HIV.My condition is considered high-intermediate risk.I have an active Hepatitis B or C infection.My blood tests within the last month show normal results.My kidney and liver are functioning well.I have not had cancer, except for skin cancer or early prostate cancer, in the last 3 years.I am currently being treated for an infection.I have not received a live vaccine in the last 30 days.I am of childbearing age and my pregnancy test is negative.I agree to use birth control during the study.I have had radiation, chemotherapy, or immunotherapy for head and neck cancer.I have been treated for an autoimmune disease in the last 2 years.I agree to use birth control during the study.I have or had lung inflammation not caused by an infection.I have had major surgery to remove my cancer.My cancer has spread to distant parts of my body.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.My cancer is p16-positive in the throat, voice box, or mouth.
Research Study Groups:
This trial has the following groups:- Group 1: Control-radiotherapy/cisplatin
- Group 2: Experimental-Radiotherapy/pembrolizumab
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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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