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Chemotherapy

Cisplatin + Pembrolizumab for Head and Neck Cancer

Phase 2
Waitlist Available
Led By Trisha Wise-Draper, MD, PhD
Research Sponsored by Trisha Wise-Draper
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must be willing to undergo definitive resection with neck dissection
Performance status 0 or 1 on Eastern Cooperative Oncology Group Performance Scale
Must not have
Human Papillomavirus (HPV)+ disease of the oropharynx
Nasopharyngeal or sinonasal carcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial tests adding a new therapy to standard cancer treatment for head and neck cancer to see if it is safe and helpful.

Who is the study for?
This trial is for adults with head and neck squamous cell carcinoma who are fit enough for surgery, have certain high-risk cancer features, and can handle standard treatments. They must not have immune deficiencies, be on recent immunosuppressants, or have specific other cancers or infections like TB or hepatitis.
What is being tested?
The study tests adding pembrolizumab to the usual care (surgery plus radiation) for head and neck cancer. Some patients may also get cisplatin if their cancer is 'high risk'. The goal is to see if pembrolizumab improves outcomes when combined with these standard therapies.
What are the potential side effects?
Pembrolizumab might cause immune system-related side effects such as inflammation in various organs, skin reactions, fatigue, flu-like symptoms; Cisplatin can lead to nausea, kidney issues, hearing problems; Radiation may result in skin irritation and soreness in treated areas.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to have surgery to remove a tumor and neck lymph nodes.
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I can carry out all my usual activities without help.
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My cancer is advanced but can be surgically removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My throat cancer is caused by HPV.
Select...
My cancer is located in the nasopharynx or sinonasal region.
Select...
I do not have a history of TB, autoimmune diseases, pneumonitis, infections, HIV, Hepatitis B or C.
Select...
My cancer has spread to other parts of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease Free Survival in Resected High Risk Patients Treated With Adjuvant Pembrolizumab and Chemoradiation
Disease Free Survival in Resected Intermediate Risk Patients Treated With Adjuvant Pembrolizumab and Radiation
Number of Participants With Treatment Related Adverse Effects
Secondary study objectives
Overall Survival in Resected High Risk Patients Treated With Adjuvant Pembrolizumab and Chemoradiation
Overall Survival in Resected Intermediate Risk Patients Treated With Adjuvant Pembrolizumab and Radiation
Tumor Immune Response to Pembrolizumab as Defined by PD-L1 CPS in the Baseline Tumor Tissue

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999
64%
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%
Clostridium difficile colitis
1%
Systemic infection
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
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab

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

1Treatment groups
Experimental Treatment
Group I: PembrolizumabExperimental Treatment4 Interventions
Pembrolizumab in combination with standard of care surgery followed by radiation therapy with or without cisplatin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved
Pembrolizumab
FDA approved
Surgery
2000
Completed Phase 3
~2490
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

Trisha Wise-DraperLead Sponsor
5 Previous Clinical Trials
136 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,010 Previous Clinical Trials
5,185,131 Total Patients Enrolled
Trisha Wise-Draper, MD, PhDPrincipal InvestigatorUniversity of Cincinnati
4 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

Cisplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT02641093 — Phase 2
Head and Neck Cancers Research Study Groups: Pembrolizumab
Head and Neck Cancers Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT02641093 — Phase 2
Cisplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02641093 — Phase 2
~10 spots leftby Nov 2025
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