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.

NCT05061940 | Terminated

• 1 other identifier: SCR-103
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Tumor Profiling DIAGNOSTIC_TEST

Testing TAA and HPV expression. HLA typing.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients eligible for inclusion in this study must meet all of the following criteria:

You may qualify if:

• 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

Sponsors & Collaborators

• Repertoire Immune Medicines: lead

Study Sites (3)

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Sarah Cannon Cancer Center

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Melanoma; Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Spriggs, MD

  Repertoire Immune Medicines

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: September 30, 2021
• Study Start: May 5, 2021
• Primary Completion: October 11, 2022
• Study Completion: October 11, 2022
• Last Updated: December 6, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)