The Addition of Pembrolizumab to Postoperative Radiotherapy in Cutaneous Squamous Cell Cancer of the Head and Neck
|ClinicalTrials.gov Identifier: NCT03057613|
Recruitment Status : Completed
First Posted : February 20, 2017
Results First Posted : October 19, 2020
Last Update Posted : November 16, 2020
A small group of skin cancers of the head and neck, called resected cutaneous squamous carcinomas, are more aggressive than most cancers of this type, even after being treated with standard therapy. This trial will use stronger treatment to look at the safety and effectiveness (efficacy) of combining a drug called Pembrolizumab with radiation after a cancer has already been treated to suppress secondary tumor formation in high risk cutaneous squamous cell cancer of the head and neck.
Primary Objective To assess safety by looking at the people with dose limiting responses
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma of the Head and Neck||Drug: Pembrolizumab Radiation: IMRT 60-66Gy||Phase 2|
To assess safety and estimate 1-year progression-free survival (PFS) of postoperative radiation therapy (RT) + concurrent and adjuvant Pembrolizumab in high risk resected cutaneous squamous cell cancer of the head and neck (cSCC-HN).
- To evaluate the relationship of baseline programmed death-ligand 1 (PD-L1) expression by tumor and tumor-infiltrating lymphocytes (TILs) to preliminary efficacy .
- To phenotype tumor infiltrating lymphocytes and peripheral blood lymphocytes (PBLs), and investigate tumor suppressor populations including Tregs, myeloid-derived suppressor cells (MDSCs) and cluster of differentiation 8 (CD8) suppressor cells and assess ex vivo for effector function by cytokine production and cytotoxicity assays as well as suppressor function in assays with autologous PBLs.
- To evaluate the tumor microenvironment (TME), and immune markers at the invasive margin of the tumor, including CD8, PD-1, PD-L1, TIM-3, galectin-9 or HMGB-1, BTLA and HVEM, as well as Lag-3, CTLA-4 and others.
- To evaluate the genomic and/or transcriptomic profile of these tumors using RNA-seq /Whole Transcriptome Shotgun Sequencing
This is a phase II trial evaluating the addition of concurrent and adjuvant fixed-dose pembrolizumab in combination with standard intensity-modulated radiation therapy (IMRT), in order to establish safety and estimate efficacy of this regimen to be tested in a subsequent randomized registration trial.
Thirty seven patients will be enrolled.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of the Addition of Pembrolizumab to Postoperative Radiotherapy in Resected High Risk Cutaneous Squamous Cell Cancer of the Head and Neck|
|Actual Study Start Date :||May 10, 2017|
|Actual Primary Completion Date :||June 26, 2020|
|Actual Study Completion Date :||September 9, 2020|
Experimental: Pembrolizumab + post operative radiotherapy
IMRT 60-66Gy for 6 weeks in combination with Pembrolizumab every 3 weeks for 16 weeks
200mg every 3 weeks for 16 weeks given by IV infusion
Radiation: IMRT 60-66Gy
60-66Gy for 6 weeks
- Number of Subjects With Dose Limiting Toxicities [ Time Frame: Up to 20 weeks post treatment ]There will be an initial safety run in cohort consisting of an initial safety run in cohort consisting of eight patients to allow for at least six evaluable patients for dose limiting toxicities (DLTs) by the week 20 visit. If a total of 0-2 of the initial six evaluable patients experience DLTs, the safety run in will have been deemed successful and the 29 remaining planned patients will be accrued. DLT for this study is defined as the occurrence of a severe adverse event (AE) that is at least possibly related to pembrolizumab, and occurs from the initiation of treatment thru 30 days after the final administration of the study treatment
- Progression Free Survival [ Time Frame: Up to 1 year after beginning treatment ]Progression-free survival (PFS) will be calculated from treatment initiation to disease progression or death from any cause or last follow up
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057613
|United States, Ohio|
|University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Shlomo Koyfman, MD||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|