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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 22
- Locations
- 3
- Primary Endpoint
- Frequency of subjects with the expression of multiple tumor associated antigens and/or HPV-16 E6/E7.
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Frequency of subjects with the expression of multiple tumor associated antigens and/or HPV-16 E6/E7.
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported