COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu
Trial record 1 of 1 for:    NCT02641093
Previous Study | Return to List | Next Study

Phase II Trial of Adjuvant Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02641093
Recruitment Status : Recruiting
First Posted : December 29, 2015
Last Update Posted : October 28, 2019
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Trisha Wise-Draper, University of Cincinnati

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: Pembrolizumab Procedure: Surgery Radiation: Radiation Therapy Drug: Cisplatin Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Investigation of Adjuvant Combined Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma
Study Start Date : January 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Pembrolizumab
Pembrolizumab in combination with standard of care surgery followed by radiation therapy with or without cisplatin
Drug: Pembrolizumab
Pembrolizumab administered one week prior to surgery and then every three weeks in the adjuvant setting for a total of 7 doses.
Other Name: Keytruda

Procedure: Surgery
gross total surgical resection

Radiation: Radiation Therapy
60-66 Gy over 6 weeks

Drug: Cisplatin
Weekly during radiation therapy for 6 doses only for patients with high risk pathological features

Primary Outcome Measures :
  1. Number of participants with treatment related adverse effects as assessed using CTCAE v4.0 of pembrolizumab when combined with radiation alone and chemoradiation [ Time Frame: 30 days following completion of treatment ]
    Compare percentage of grade 3 and 4 adverse events with historical control percentages.

  2. Disease free survival in resected high risk patients treated with adjuvant pembrolizumab and chemoradiation [ Time Frame: 1 and 3 year ]
  3. Disease free survival in resected intermediate risk patients treated with adjuvant pembrolizumab and radiation [ Time Frame: 1 and 3 year ]

Secondary Outcome Measures :
  1. Tumor immune response to pembrolizumab as measured by immunohistochemistry in tumor tissue before and after treatment [ Time Frame: 1 week ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients eligible for resection with one or more of the following

    1. Any T stage with ≥ N2 disease;
    2. T4 disease, any N stage;
    3. T3 Oral Cavity, any N stage; or
    4. Clinical evidence of extra-capsular extension on scans.
  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02641093

Layout table for location contacts
Contact: UC Cancer Institute Clinical Trials Office 513-584-7698

Layout table for location information
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States
Contact: Frank Worden, MD         
Principal Investigator: Frank Worden, MD         
United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45219
Contact: UC Cancer Institute Clinical Trials Office    513-584-7698   
Principal Investigator: Trisha Wise-Draper, MD, PhD         
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Katrina Banyas, BS    614-685-2127   
Principal Investigator: Matthew Old, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States
Contact: Brittanie Weinerman    843-792-6349   
Principal Investigator: Paul O'Brien, MD         
Sponsors and Collaborators
Trisha Wise-Draper
Merck Sharp & Dohme Corp.
Layout table for investigator information
Principal Investigator: Trisha Wise-Draper, MD, PhD University of Cincinnati
Layout table for additonal information
Responsible Party: Trisha Wise-Draper, Principal Investigator, University of Cincinnati Identifier: NCT02641093    
Other Study ID Numbers: UCCI-HN-15-01
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents
Antineoplastic Agents, Immunological