Head and Neck CancerPhase 2NCT02641093
Phase II Trial of Adjuvant Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing Pembrolizumab, Surgery and Radiation Therapy in people with Head and Neck Cancer, run by Trisha Wise-Draper at 6 sites in United States.
Trial summary
The purpose of this research study is to test the safety and the benefit of adding pembrolizumab (a therapy that activates the immune system to fight cancer) to standard of care treatment for head and neck cancer. The standard of care treatment will include surgery followed by radiation for 6 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Pembrolizumab, Surgery and Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2016to 2 Nov 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients eligible for resection with one or more of the following
- Any T stage with ≥ N2 disease;
- T4 disease, any N stage;
- T3 Oral Cavity, any N stage; or
- Clinical evidence of extra-capsular extension on scans.
- Must be willing to undergo definitive resection with neck dissection.
Show all 9Show fewer
- Performance status 0 or 1 on Eastern Cooperative Oncology Group Performance Scale.
- Adequate labs
- Appropriate staging imaging.
Who cannot join
- Diagnosis of immunodeficiency or receiving systemic steroid therapy or immunosuppressive therapy within 7 days prior to planned first dose of trial treatment.
- Nasopharyngeal or sinonasal carcinoma
- Confirmed metastatic disease
- Human Papillomavirus (HPV)+ disease of the oropharynx
- Known history of active tuberculosis (TB), autoimmune disease, pneumonitis, infection, HIV, Hepatitis B, or Hepatitis C
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Michigan
Ann Arbor, Michigan, 48109
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Ohio State University
Columbus, Ohio, 43210
MD Anderson Cancer Center
Houston, Texas, 77030
University of Louisville - James Graham Brown Cancer Center
Louisville, Kentucky, 40202
About this study
Official title: Phase II Investigation of Adjuvant Combined Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma
The purpose of this research study is to test the safety and the benefit of adding pembrolizumab (a therapy that activates the immune system to fight cancer) to standard of care treatment for head and neck cancer. The standard of care treatment will include surgery followed by radiation for 6 weeks. Some patients may also receive cisplatin as standard of care once a week for 6 weeks if the cancer is found to be "high risk". High risk includes cancer that was not completely removed (positive margins) or cancer that has invaded through the outer lining of your lymph nodes.
- Conditions
- Head and Neck Cancer
- Being tested
- Pembrolizumab, Surgery, Radiation Therapy, Cisplatin
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda
Pembrolizumab administered one week prior to surgery and then every three weeks in the adjuvant setting for a total of 7 doses.
SurgeryProcedure or surgery
gross total surgical resection
Radiation TherapyRadiation
60-66 Gy over 6 weeks
CisplatinDrug
Weekly during radiation therapy for 6 doses only for patients with high risk pathological features
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab | Experimental | Pembrolizumab in combination with standard of care surgery followed by radiation therapy with or without cisplatin Receives: Drug: Pembrolizumab; Procedure: Surgery; Radiation: Radiation Therapy; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Related Adverse Effects
Number of participants with treatment related adverse effects as assessed using CTCAE v4.0 of pembrolizumab when combined with radiation alone and chemoradiation. Compared as percentage of grade 3 and 4 adverse events with historical control percentages.
Measured: All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution.
Disease Free Survival in Resected High Risk Patients Treated With Adjuvant Pembrolizumab and Chemoradiation
- High risk is defined as those with biopsies that have the following features: extracapsular spread or those with positive surgical margins.
Measured: 1 year
Disease Free Survival in Resected Intermediate Risk Patients Treated With Adjuvant Pembrolizumab and Radiation
- Intermediate risk is defined as those with biopsies that do not have the following features: extracapsular spread or those with positive surgical margins.
Measured: 1 year
Secondary outcomes (3)
Tumor Immune Response to Pembrolizumab as Defined by PD-L1 CPS in the Baseline Tumor Tissue
Change in distribution of the tumor immune microenvironment after Pembrolizumab administration in tumor biopsy tissue using markers of T cells and T cell activation using PD-L1 CPS. PD-L1 CPS is defined as the PD-L1 combined positive score. PD-L1 CPS is defined as Combined positivity score (CPS) was calculated by summing the numbers of PD-L1-positive tumor cells and immune cells and dividing by the total number of viable tumor cells. Additionally, PD-L1 is a protein that helps the body immune system remain in control.
The denominator in this case is 72 subjects that were evaluable. Evaluable means the subject had a pre-surgery pembrolizumab and a biopsy taken. The numerators are explained below.
Measured: 1 week between receiving a pre-surgery dose of pembrolizumab and surgery when the biopsy was taken
Overall Survival in Resected Intermediate Risk Patients Treated With Adjuvant Pembrolizumab and Radiation
- Intermediate risk is defined as those with biopsies that do not have the following features: extracapsular spread or those with positive surgical margins
Measured: 1 year
Overall Survival in Resected High Risk Patients Treated With Adjuvant Pembrolizumab and Chemoradiation
- High risk is defined as those with biopsies that have the following features: extracapsular spread or those with positive surgical margins.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startJan 2016
- Primary completion16 Apr 2021
- Study completion2 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trisha Wise-Draper
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Trisha Wise-Draper, University of Cincinnati
- Investigators
- Trisha Wise-Draper, MD, PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641093
- Sponsor's protocol ID
- UCCI-HN-15-01
- Status last verified
- Apr 2026
- First submitted
- 21 Dec 2015
- Last updated
- 4 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Bandaru R, Fu H, Zheng H, Liang J, Wang L, Gulati S, Hinrichs BH, Teng M, Zhang B, Kocherginsky M, Lin DC, Hildeman DA, Worden FP, Old M, Dunlap NE, Kaczmar JM, Gillison ML, El-Gamal D, Wise Draper T, Liu Y. Genome-wide variation in cell-free DNA end-motif entropy predicts immunotherapy response in head and neck cancer. J Clin Invest. 2026 May 19;136(13):e196284. doi: 10.1172/JCI196284. eCollection 2026 Jul 1.
PubMed 42154530
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Investigation of Adjuvant Combined Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02641093
- Acronym / sponsor ID
- UCCI-HN-15-01
- Conditions
- Head and Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Trisha Wise-DraperUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2016 (actual)
- Primary completion
- 16 Apr 2021 (actual)
- Study completion
- 2 Nov 2026 (estimated)
- First posted
- 29 Dec 2015 (estimated)
- Results
- Posted 6 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to test the safety and the benefit of adding pembrolizumab (a therapy that activates the immune system to fight cancer) to standard of care treatment for head and neck cancer. The standard of care treatment will include surgery followed by radiation for 6 weeks. Some patients may also receive cisplatin as standard of care once a week for 6 weeks if the cancer is found to be "high risk". High risk includes cancer that was not completely removed (positive margins) or cancer that has invaded through the outer lining of your lymph nodes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab | Experimental | Drug: Pembrolizumab, Procedure: Surgery, Radiation: Radiation Therapy, Drug: CisplatinPembrolizumab in combination with standard of care surgery followed by radiation therapy with or without cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients eligible for resection with one or more of the following
- Must be willing to undergo definitive resection with neck dissection.
- Performance status 0 or 1 on Eastern Cooperative Oncology Group Performance Scale.
- Adequate labs
- Appropriate staging imaging.
Key exclusion criteria (5 listed)
- Diagnosis of immunodeficiency or receiving systemic steroid therapy or immunosuppressive therapy within 7 days prior to planned first dose of trial treatment.
- Nasopharyngeal or sinonasal carcinoma
- Confirmed metastatic disease
- Human Papillomavirus (HPV)+ disease of the oropharynx
- Known history of active tuberculosis (TB), autoimmune disease, pneumonitis, infection, HIV, Hepatitis B, or Hepatitis C
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabAlso: KeytrudaPembrolizumab administered one week prior to surgery and then every three weeks in the adjuvant setting for a total of 7 doses. | Drug | Pembrolizumab |
| Surgerygross total surgical resection | Procedure or surgery | Pembrolizumab |
| Radiation Therapy60-66 Gy over 6 weeks | Radiation | Pembrolizumab |
| CisplatinWeekly during radiation therapy for 6 doses only for patients with high risk pathological features | Drug | Pembrolizumab |
Primary outcome
Number of Participants With Treatment Related Adverse Effects
Time frame: All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution.
Number of participants with treatment related adverse effects as assessed using CTCAE v4.0 of pembrolizumab when combined with radiation alone and chemoradiation. Compared as percentage of grade 3 and 4 adverse events with historical control percentages.
Disease Free Survival in Resected High Risk Patients Treated With Adjuvant Pembrolizumab and Chemoradiation
Time frame: 1 year
• High risk is defined as those with biopsies that have the following features: extracapsular spread or those with positive surgical margins.
Disease Free Survival in Resected Intermediate Risk Patients Treated With Adjuvant Pembrolizumab and Radiation
Time frame: 1 year
• Intermediate risk is defined as those with biopsies that do not have the following features: extracapsular spread or those with positive surgical margins.
3 secondary outcomes
Tumor Immune Response to Pembrolizumab as Defined by PD-L1 CPS in the Baseline Tumor Tissue
Time frame: 1 week between receiving a pre-surgery dose of pembrolizumab and surgery when the biopsy was taken
Overall Survival in Resected Intermediate Risk Patients Treated With Adjuvant Pembrolizumab and Radiation
Time frame: 1 year
Overall Survival in Resected High Risk Patients Treated With Adjuvant Pembrolizumab and Chemoradiation
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42154530Bandaru R, Fu H, Zheng H, Liang J, Wang L, Gulati S, Hinrichs BH, Teng M, Zhang B, Kocherginsky M, Lin DC, Hildeman DA, Worden FP, Old M, Dunlap NE, Kaczmar JM, Gillison ML, El-Gamal D, Wise Draper T, Liu Y. Genome-wide variation in cell-free DNA end-motif entropy predicts immunotherapy response in head and neck cancer. J Clin Invest. 2026 May 19;136(13):e196284. doi: 10.1172/JCI196284. eCollection 2026 Jul 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trisha Wise-Draper, MD, PhD principal investigator
University of Cincinnati
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab, Surgery and Radiation Therapy in people with Head and Neck Cancer, run by Trisha Wise-Draper at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Related Adverse Effects (time frame: All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02641093, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.