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.

Repertoire Immune Medicines

Status: Terminated

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

Treatments: Diagnostic Test: Tumor Profiling

Study type: Observational

Funder types: Industry

Identifiers

NCT05061940

SCR-103

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.