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Active, Not Recruiting

NCT Number: NCT02641093

Phase II Trial of Adjuvant 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Louisville - James Graham Brown Cancer Center, Louisville, Kentucky, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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

Treatment and study plan

Pembrolizumab

Drug

Pembrolizumab administered one week prior to surgery and then every three weeks in the adjuvant setting for a total of 7 doses.

Other names: Keytruda

Surgery

Procedure

gross total surgical resection

radiation therapy

Radiation

60-66 Gy over 6 weeks

Cisplatin

Drug

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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

    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.

  2. Overall 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. Overall 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.

Sponsors and collaborators

Lead sponsor

Trisha Wise-Draper

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2026
First posted
Dec 29, 2015
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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