Memory Phenotype and PD-1 Inhibition Response in Oral Cancer

NCT03862066 | Terminated

• 1 other identifier: 102985
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Keywords

head and neck cancer

Outcome Measures

Primary Outcomes (1)

• Count of PDX models that are developed from patient samples

  It is anticipated that there will be 12 successful PDX models developed as part of this study.

  6 months

Secondary Outcomes (2)

• Change in tumor growth in PDX models

  6 months

• Change in tumor volume in PDX models

  6 months

Study Arms (2)

Received Nivolumab

Other: Blood collection; Other: Tissue collection

Nivolumab Naive

Other: Blood collection; Other: Tissue collection

Interventions

Blood collection OTHER

5 milliliters (mL) of blood will be collected at the time of surgery

Nivolumab Naive; Received Nivolumab

Tissue collection OTHER

Left over tissue will be collected at the time of surgery

Nivolumab Naive; Received Nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be selected from cancer patients being seen at MUSC.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue and blood specimens

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Interventions

Blood Specimen Collection; Tissue Banks

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Biological Specimen Banks; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• David Neskey, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 5, 2019
• Study Start: February 8, 2019
• Primary Completion: June 30, 2021
• Study Completion: November 22, 2021
• Last Updated: August 11, 2022

Record last verified: 2022-08

Locations

US (1)