Melanoma Clinical Trial

A Screening Study to Collect Samples for TAA, HLA & HLA Loss of Heterozygosity in Patients With Metastatic Solid Tumors

Summary

TScan Therapeutics is developing cellular therapies across multiple solid tumors in which autologous participant-derived T cells are engineered to express a T cell receptor that recognizes cancer-associated antigens presented on specific Human Leukocyte Antigen (HLA) molecules. The purpose of this screening study is to collect samples to conduct HLA genotyping, HLA Loss of Heterozygosity (LOH) and expression of Tumor-associated Antigens (TAA) testing. These results will be used to determine if subjects meet the eligibility criteria for these parameters and could potentially be enrolled in a TScan clinical treatment study.

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Full Description

This multicenter screening study will be conducted to determine a subject's tumor antigen expression profile, HLA genotype and HLA LOH for TScan sponsored clinical treatment study(s). No treatment intervention will occur as part of this screening study.

Subjects will be required to provide a buccal swab to assess their HLA status. If they are positive for certain types of HLA, they will return for a subsequent visit to provide a saliva sample to assess HLA loss of heterozygosity. In parallel, archival tissue (less than 6 months old) will be needed to assess for tumor antigen expression. If archival tissue is older than six months, a fresh tumor biopsy will be required at the time of the second visit.

If eligible, subjects will be referred to appropriate available interventional trial(s) at the discretion of the Investigator.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Willing and able to provide written informed consent.
Male or female aged ≥18 years at the time of signing the informed consent.
Have one of the following histologically or cytologically confirmed locally advanced (unresectable) or metastatic solid tumor:
Head and neck cancer
Cervical cancer
Non-small cell lung cancer
Melanoma
Ovarian cancer
HPV positive anogenital cancers
Willing to provide a buccal swab for HLA testing
Willing to provide a saliva sample to use as a normal control for the LOH assay
Have access to an FFPE tumor block that is <6 months old or is willing to provide a fresh core-needle biopsy.

Exclusion Criteria:

• Participants undergoing anticancer therapy with curative intent such as tumor surgical resection with or without neoadjuvant/adjuvant therapy, or definitive chemoradiation, unless they have locoregionally advanced disease and are expected to have a high risk of relapse after their curative intent therapy as determined by the treating investigator.

Study is for people with:

Melanoma

Estimated Enrollment:

650

Study ID:

NCT05812027

Recruitment Status:

Recruiting

Sponsor:

TScan Therapeutics, Inc.

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There are 14 Locations for this study

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HonorHealth Research and Innovation Institute
Scottsdale Arizona, 85258, United States More Info
Justin Moser, MD
Contact
480-323-1364
[email protected]
Yale Cancer Center
New Haven Connecticut, 06510, United States More Info
Jialing Zhang
Contact
475-234-9684
[email protected]
Michael Hurwitz, MD
Principal Investigator
Memorial Healthcare System
Hollywood Florida, 33021, United States More Info
Brian Pico, MD
Contact
954-265-1847
[email protected]
University of Miami, Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States More Info
Rakhi Modak
Contact
[email protected]
Jose Lutzky, MD
Principal Investigator
Orlando Health
Orlando Florida, 32806, United States More Info
Melinda Porter
Contact
321-841-7246
[email protected]
Sajeve Thomas, MD
Principal Investigator
Norton Cancer Institute
Louisville Kentucky, 40202, United States More Info
Jaspreet Grewal, MD
Principal Investigator
Karmanos Cancer Institute
Detroit Michigan, 48201, United States More Info
Marie Ventimiglia
Contact
313-576-9271
[email protected]
Ira Winer, MD
Principal Investigator
University of Minnesota, Masonic Cancer Center
Minneapolis Minnesota, 55455, United States More Info
Manar Al-Assi
Contact
[email protected]
Columbia University Herbert Irving Comprehensive Cancer Center
New York New York, 10032, United States More Info
Elizabeth Shelton, MPH
Contact
[email protected]
Brian Henick, MD
Principal Investigator
University of North Carolina at Chapel Hill
Chapel Hill North Carolina, 27599, United States More Info
Jared Weiss, MD
Contact
[email protected]
The Cleveland Clinic
Cleveland Ohio, 44195, United States More Info
Sarah Kabalan
Contact
866-223-8100
[email protected]
James Isaacs, MD
Principal Investigator
Providence Cancer Institute Franz Clinic
Portland Oregon, 97213, United States More Info
Rom Leidner, MD
Contact
503-215-2614
[email protected]
Rom Leidner, MD
Principal Investigator
Allegheny Hospitals Network
Pittsburgh Pennsylvania, 15224, United States More Info
Shelly Evans
Contact
[email protected]
Yazan Samhouri, MD
Principal Investigator
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15232, United States More Info
Barb Stadterman
Contact
[email protected]
Jason Luke, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Estimated Enrollment:

650

Study ID:

NCT05812027

Recruitment Status:

Recruiting

Sponsor:


TScan Therapeutics, Inc.

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