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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

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.

Condition or disease Intervention/treatment
Squamous Cell Carcinoma of the Head and Neck Other: Blood collection Other: Tissue collection

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.

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Study Type : Observational
Estimated Enrollment : 17 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of the Central Memory Phenotype in Predicting Response to PD-1 Inhibition in Pre-clinical Models of Oral Cancer
Actual Study Start Date : February 8, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : April 1, 2020

Group/Cohort Intervention/treatment
Received Nivolumab 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

Nivolumab Naive 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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be selected from cancer patients being seen at MUSC.

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03862066

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Contact: David Neskey, MD 843-876-0716

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United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: David S. Neskey, MD         
Sponsors and Collaborators
Medical University of South Carolina
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Principal Investigator: David Neskey, MD Medical University of South Carolina

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Responsible Party: Medical University of South Carolina Identifier: NCT03862066    
Other Study ID Numbers: 102985
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University of South Carolina:
head and neck cancer
Additional relevant MeSH terms:
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Mouth Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Squamous Cell Carcinoma of Head and Neck
Carcinoma, Squamous Cell
Stomatognathic Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents