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

Primary Purpose

Head and Neck Cancer

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pembrolizumab
Surgery
Radiation Therapy
Cisplatin
Sponsored by
Trisha Wise-Draper
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Louisville - James Graham Brown Cancer Center
  • University of Michigan
  • University of Cincinnati Medical Center
  • Ohio State University
  • Medical University of South Carolina
  • MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pembrolizumab

Arm Description

Pembrolizumab in combination with standard of care surgery followed by radiation therapy with or without cisplatin

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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
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.

Full Information

First Posted
December 21, 2015
Last Updated
April 11, 2023
Sponsor
Trisha Wise-Draper
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02641093
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2016 (Actual)
Primary Completion Date
April 16, 2021 (Actual)
Study Completion Date
November 2, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Trisha Wise-Draper
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pembrolizumab
Arm Type
Experimental
Arm Description
Pembrolizumab in combination with standard of care surgery followed by radiation therapy with or without cisplatin
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
Keytruda
Intervention Description
Pembrolizumab administered one week prior to surgery and then every three weeks in the adjuvant setting for a total of 7 doses.
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
gross total surgical resection
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Intervention Description
60-66 Gy over 6 weeks
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Weekly during radiation therapy for 6 doses only for patients with high risk pathological features
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Related Adverse Effects
Description
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.
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.
Title
Disease Free Survival in Resected High Risk Patients Treated With Adjuvant Pembrolizumab and Chemoradiation
Description
• High risk is defined as those with biopsies that have the following features: extracapsular spread or those with positive surgical margins.
Time Frame
1 year
Title
Disease Free Survival in Resected Intermediate Risk Patients Treated With Adjuvant Pembrolizumab and Radiation
Description
• Intermediate risk is defined as those with biopsies that do not have the following features: extracapsular spread or those with positive surgical margins.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Tumor Immune Response to Pembrolizumab as Defined by PD-L1 CPS in the Baseline Tumor Tissue
Description
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.
Time Frame
1 week between receiving a pre-surgery dose of pembrolizumab and surgery when the biopsy was taken
Title
Overall Survival in Resected Intermediate Risk Patients Treated With Adjuvant Pembrolizumab and Radiation
Description
• Intermediate risk is defined as those with biopsies that do not have the following features: extracapsular spread or those with positive surgical margins
Time Frame
1 year
Title
Overall Survival in Resected High Risk Patients Treated With Adjuvant Pembrolizumab and Chemoradiation
Description
• High risk is defined as those with biopsies that have the following features: extracapsular spread or those with positive surgical margins.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trisha Wise-Draper, MD, PhD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville - James Graham Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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