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NCT05061940 Clinical Trial

This SCR-103 Protocol Will Permit Sites to Proactively Assess TAA, HLA and HPV-16 Status in Patients With Selected Solid Tumors to Determine Suitability for Repertoire Immune Medicines Treatment Protocols.

Head and Neck Cancer Clinical Trial

Official title:
Screening Protocol to Assess the Expression of Tumor Associated Antigens (TAAs), Human Papillomavirus (HPV-16) Antigens and Human Leucocyte Antigen (HLA) Sub-Types in Patients With Head and Neck, Cervical, Melanoma and Non-Small Cell Lung Cancers.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT05061940
Other study ID # SCR-103
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date May 5, 2021
Est. completion date October 11, 2022

Study information
Verified date December 2022
Source Repertoire Immune Medicines
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to obtain archived tumor tissue or pre-existing antigen expression data from patients with Head and Neck, Cervical, Melanoma and Non-Small Cell Lung Cancers to assess antigen expression and patient suitability for a Repertoire Immune Medicines Treatment Protocol.

Description:

This screening study is intended for men and women at least 18 years of age who have selected advanced solid tumors. The study will assess the patient's selected tumor antigens and/or HPV-16 E6/E7 expression profiles. Human leukocyte antigen (HLA) subtype will also be assessed. Based on the results, it will be determined if a patient is eligible to be considered for a Repertoire Immune Medicines sponsored clinical trial(s) testing of the safety and efficacy of a multi-antigen cytokine-enhanced T cell therapy. No treatment intervention will occur as part of this screening study. Upon enrollment, patients will be required to provide archival tumor tissue and saliva samples. Based upon the results of these diagnostic analyses, if eligible, patients may be enrolled in an appropriate interventional clinical trial(s) at the discretion of the Investigator.

Recruitment information / eligibility
Status Terminated
Enrollment 22
Est. completion date October 11, 2022
Est. primary completion date October 11, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Be willing and able to provide written informed consent - Age = 18 years - Histologically- or cytologically-confirmed, relapsed/refractory, and metastatic or locally advanced head and neck, cervical, melanoma or non-small cell lung cancers. Other solid tumor types may be analyzed at the discretion of the Sponsor - Able to provide archived tumor tissue or have existing data on TAAs, HPV status or HLA sub-type - Willing to provide a saliva sample Exclusion Criteria: - There are no exclusion criteria for this study.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Tumor Profiling
Testing TAA and HPV expression. HLA typing.

Locations
Country Name City State
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Sarah Cannon Cancer Center Nashville Tennessee
United States HonorHealth Research Institute Scottsdale Arizona

Sponsors (1)
Lead Sponsor Collaborator
Repertoire Immune Medicines

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency of subjects with the expression of multiple tumor associated antigens and/or HPV-16 E6/E7. To identify patients with Head and Neck, Cervical, Melanoma and Non-Small Cell Lung Cancer that could potentially be eligible for Repertoire Immune Medicines clinical trials. 5 years
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