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Memory Phenotype in Oral Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03862066
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : March 25, 2019
Information provided by (Responsible Party):
Medical University of South Carolina

Tracking Information
First Submitted Date March 1, 2019
First Posted Date March 5, 2019
Last Update Posted Date March 25, 2019
Actual Study Start Date February 8, 2019
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 1, 2019)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03862066 on Archive Site
Current Secondary Outcome Measures
 (submitted: March 1, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Memory Phenotype in Oral Cancer
Official Title The Role of the Central Memory Phenotype in Predicting Response to PD-1 Inhibition in Pre-clinical Models of Oral Cancer
Brief Summary The purpose of this research study is collect tissue and blood samples from patients who are having surgery and use those samples in lab studies to see if there are any markers in blood and tissue that can help predict how cancer will react to different treatment. Participants in this study will have a blood sample and tissue samples collected for research. The blood and tissue collected will be tested in the laboratory. The tissue collected will be left over tissue from the standard of care surgery.
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 Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants will be selected from cancer patients being seen at MUSC.
Condition Squamous Cell Carcinoma of the Head and Neck
  • Other: Blood collection
    5 milliliters (mL) of blood will be collected at the time of surgery
  • Other: Tissue collection
    Left over tissue will be collected at the time of surgery
Study Groups/Cohorts
  • Received Nivolumab
    • Other: Blood collection
    • Other: Tissue collection
  • Nivolumab Naive
    • Other: Blood collection
    • Other: Tissue collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 1, 2019)
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 1, 2020
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contact: David Neskey, MD 843-876-0716
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT03862066
Other Study ID Numbers 102985
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Medical University of South Carolina
Study Sponsor Medical University of South Carolina
Collaborators Not Provided
Principal Investigator: David Neskey, MD Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date March 2019