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

NCT02641093

Description:

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.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
  • Oropharyngeal Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Phase II Trial of Adjuvant Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma
  • Official Title: Phase II Investigation of Adjuvant Combined Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: UCCI-HN-15-01
  • NCT ID: NCT02641093

Conditions

  • Head and Neck Cancer

Interventions

DrugSynonymsArms
PembrolizumabKeytrudaPembrolizumab
CisplatinPembrolizumab

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
PembrolizumabExperimentalPembrolizumab in combination with standard of care surgery followed by radiation therapy with or without cisplatin
  • Pembrolizumab
  • Cisplatin

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:Compare percentage of grade 3 and 4 adverse events with historical control percentages.

Secondary Outcome Measures

Measure:Tumor immune response to pembrolizumab as measured by immunohistochemistry in tumor tissue before and after treatment
Time Frame:1 week
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Trisha Wise-Draper

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