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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 2 trial • 57 Patients • NCT03004183
21%
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

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
~2550
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
3,886 Previous Clinical Trials
5,054,475 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Phase II Trial of Adjuvant Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma
Trisha Wise-Draper 2016. "Phase II Trial of Adjuvant Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02641093.
All > Squamous Cell Carcinoma
~10 spots leftby Apr 2025
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