- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03862066
Memory Phenotype and PD-1 Inhibition Response in Oral Cancer
The Role of the Central Memory Phenotype in Predicting Response to PD-1 Inhibition in Pre-clinical Models of Oral Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Squamous cell carcinoma of the head and neck (HNSCC) is the sixth most common neoplasm in the world and despite advances in treatment, the 5-year survival remains approximately 50%. Because of the need for new therapies, the possibility of immunotherapeutic approaches for HNSCC patients has gained interest. Interest in this has continued as more than half of the subjects enrolled to an ongoing clinical trial in patients with with oral squamous cell carcinoma (OCSCC) have responded to neoadjuvant presurgical Nivolumab therapy. Additionally, unlike other solid tumors it appears responders have higher proportions of CD4+ tumor-infiltrating lymphocytes (TILs) whereas non-responders have an increase in CD8+ TILs population. Furthermore, the investigator's data suggests that response to PD-1 blockade is associated with an increase in CD45RA- CD62L+ population or central memory phenotype within TIL whereas progression of disease correlates with an increase in the CD45RA- CD62L- population or effector memory phenotype.
As previously demonstrated in several other tumor types the magnitude of response to immunotherapy directly correlates to presence of antigen specific T cells within the tumor and tumor microenvironment. Therefore, the long-term objective of this project is to identify predictive biomarkers of immune response from either TILs or tumor cells from patients with head and neck squamous carcinoma. To achieve this goal the overall objective of the current study is to develop a pre-clinical murine models in an effort to more completely evaluate the memory phenotype of TILs before and after PD-1 inhibition and to subsequently to determine the efficacy of TIL therapy in this mouse model of oral cancer. This project will test a central hypothesis that TILs derived from responders to neoadjuvant pre-surgical PD-1 inhibition in both a patient derived xenograft mouse model of oral cancer.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Hollings Cancer Center at Medical University of South Carolina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Newly diagnosed histologically proven locoregional oral squamous cell carcinoma (OSCC) without evidence of distant metastases. OSCC includes the subsites of oral tongue, floor of mouth, gingiva, retromolar trigone and buccal mucosa OR
Recurrent or persistent histologically proven locoregional OSCC that was initially treated with surgery alone.
- must be eligible for surgical resection
- greater than 18 years of age
Exclusion Criteria:
- prior immunotherapy or treatment with another anti PD-1 agent besides nivolumab
- prior chemotherapy including cetuximab or radiation therapy
- concomitant malignancies except cutaneous squamous cell carcinoma or basal cell carcinoma
- unresectable primary tumor or regional disease or distant metastases
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Received Nivolumab
|
5 milliliters (mL) of blood will be collected at the time of surgery
Left over tissue will be collected at the time of surgery
|
Nivolumab Naive
|
5 milliliters (mL) of blood will be collected at the time of surgery
Left over tissue will be collected at the time of surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Count of PDX models that are developed from patient samples
Time Frame: 6 months
|
It is anticipated that there will be 12 successful PDX models developed as part of this study.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in tumor growth in PDX models
Time Frame: 6 months
|
Tumors will be measured with calipers bi-weekly and measurements will be plotted overtime.
|
6 months
|
Change in tumor volume in PDX models
Time Frame: 6 months
|
Tumor volume with be calculated based on the two greatest dimensions of the tumor and will be plotted overtime.
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: David Neskey, MD, Medical University of South Carolina
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 102985
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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