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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02641093
• Other study ID #: UCCI-HN-15-01
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 2016
• Est. completion date: November 2, 2025

Study information

• Verified date: April 2023
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 96
• Est. completion date: November 2, 2025
• Est. primary completion date: April 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Squamous Cell Carcinoma of Head and Neck

Intervention

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

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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	Ohio State University	Columbus	Ohio
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Louisville - James Graham Brown Cancer Center	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Trisha Wise-Draper	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.
Primary	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.	1 year
Primary	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.	1 year
Secondary	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.	1 week between receiving a pre-surgery dose of pembrolizumab and surgery when the biopsy was taken
Secondary	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	1 year
Secondary	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.	1 year