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Trial record 1 of 1 for:    NCT02641093
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Phase II Trial of Adjuvant Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT02641093
Recruitment Status : Recruiting
First Posted : December 29, 2015
Last Update Posted : October 1, 2018
Sponsor:
Collaborator:
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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 : July 2019
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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT02641093


Contacts
Contact: UC Cancer Institute Clinical Trials Office 513-584-7698 cancer@uchealth.com

Locations
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    cancer@uchealth.com   
Principal Investigator: Trisha Wise-Draper, MD, PhD         
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Katrina Banyas, BS    614-685-2127    Katrina.Banyas@osumc.edu   
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    weinerma@musc.edu   
Principal Investigator: Paul O'Brien, MD         
Sponsors and Collaborators
Trisha Wise-Draper
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Trisha Wise-Draper, MD, PhD University of Cincinnati

Responsible Party: Trisha Wise-Draper, Principal Investigator, University of Cincinnati
ClinicalTrials.gov Identifier: NCT02641093     History of Changes
Other Study ID Numbers: UCCI-HN-15-01
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Pembrolizumab
Cisplatin
Antineoplastic Agents