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
• Status: Terminated
• 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
• 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Head and Neck Cancer
• HPV Positive Oropharyngeal Squamous Cell Carcinoma
• HPV-Related Carcinoma
• HPV-Related Cervical Carcinoma
• HPV-Related Malignancy
• Lung Cancer, Nonsmall Cell
• Lung Neoplasms
• Melanoma
• Melanoma (Skin)
• Squamous Cell Carcinoma of Head and Neck

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