Clinical trial NCT05061940: 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.
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.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Head and Neck Cancer
Melanoma
HPV-Related Malignancy
HPV-Related Carcinoma
HPV-Related Cervical Carcinoma
HPV Positive Oropharyngeal Squamous Cell Carcinoma
Lung Cancer, Nonsmall Cell
Melanoma (Skin)
Keywords: HPV-16 E6/E7
TT-101
PRIME-102
Metastatic
Solid Tumor
Lead sponsor: Repertoire Immune Medicines
Sponsor class: INDUSTRY
First posted: 2021-09-30
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients eligible for inclusion in this study must meet all of the following criteria:

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of subjects with the expression of multiple tumor associated antigens and/or HPV-16 E6/E7.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth Research Institute
state: Arizona
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Nashville
country: United States
facility: Sarah Cannon Cancer Center
state: Tennessee
Study officials:
affiliation: Repertoire Immune Medicines
name: David Spriggs, MD
role: STUDY_DIRECTOR
References: