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.

Terminated

• Conditions: HPV-Related Malignancy; HPV Positive Oropharyngeal Squamous Cell Carcinoma; Lung Cancer, Nonsmall Cell; Melanoma; HPV-Related Cervical Carcinoma; Head and Neck Cancer; HPV-Related Carcinoma; Melanoma (Skin)

• Registration Number: NCT05061940
• Lead Sponsor: Repertoire Immune Medicines

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-05-05
• Study First Submitted: 2021-09-20
• Study First Submitted QC: 2021-09-20
• Study First Posted: 2021-09-30
• Primary Completion: 2022-10-11
• Study Completion: 2022-10-11
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-02
• Last Update Posted: 2022-12-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of subjects with the expression of multiple tumor associated antigens and/or HPV-16 E6/E7.	5 years	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.

Trial Locations

Locations (3)

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States

HonorHealth Research Institute; 🇺🇸 Scottsdale, Arizona, United States

Sarah Cannon Cancer Center; 🇺🇸 Nashville, Tennessee, United States