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 : Active, not recruiting
First Posted : December 29, 2015
Results First Posted : May 6, 2023
Last Update Posted : May 6, 2023
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|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)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Investigation of Adjuvant Combined Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma|
|Actual Study Start Date :||January 2016|
|Actual Primary Completion Date :||April 16, 2021|
|Estimated Study Completion Date :||November 2, 2025|
Pembrolizumab in combination with standard of care surgery followed by radiation therapy with or without cisplatin
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
gross total surgical resection
Radiation: Radiation Therapy
60-66 Gy over 6 weeks
Weekly during radiation therapy for 6 doses only for patients with high risk pathological features
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- 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
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
|United States, Kentucky|
|University of Louisville - James Graham Brown Cancer Center|
|Louisville, Kentucky, United States, 40202|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Ohio|
|University of Cincinnati Medical Center|
|Cincinnati, Ohio, United States, 45219|
|Ohio State University|
|Columbus, Ohio, United States, 43210|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Trisha Wise-Draper, MD, PhD||University of Cincinnati|
Documents provided by Trisha Wise-Draper, University of Cincinnati:
|Responsible Party:||Trisha Wise-Draper, Principal Investigator, University of Cincinnati|
|Other Study ID Numbers:||
|First Posted:||December 29, 2015 Key Record Dates|
|Results First Posted:||May 6, 2023|
|Last Update Posted:||May 6, 2023|
|Last Verified:||April 2023|
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action