Screening Protocol for Preliminary Eligibility Determination for Adoptive Cell Therapy Trials

Study Overview
=================
Brief Summary
-----------------
This screening study is intended to determine preliminary eligibility of participants who may be potential candidates for GlaxoSmithKline's Adoptive T-cell therapy studies by screening for appropriate biomarkers. No treatment intervention will occur as part of this screening study.

Official Title
-----------------
A Screening Protocol to Support Preliminary Eligibility for Clinical Trials Evaluating Safety and Efficacy of Adoptive Cell Therapies in Participants With Solid Tumors and Hematologic Malignancies

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Other: Screening Platform


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed diagnosis of locally advanced high-risk eligible tumor types . Participant must be greater than or equal to (>=)18 years of age (or >=10 years of age with synovial sarcoma or myxoid/round cell liposarcoma [MRCLS]) Participants with life expectancy of greater than 6 months Performance status: Eastern Cooperative Oncology Group 0-1. Exclusion Criteria: Any prior treatment with oncology cell and/or gene therapy (unless agreed in advance with Sponsor) Prior malignancy not in complete remission. Clinically significant systemic illness Serious active infections or significant cardiac, pulmonary, hepatic or other organ dysfunction, Prior or active demyelinating disease Previous New-York Esophageal Antigen-1 (NY-ESO-1)-specific T cells, NY-ESO-1 vaccine, or NY-ESO-1 targeting antibody. Previous allogeneic hematopoietic stem cell transplant within the last 5 years or solid organ transplant.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Participants with solid tumors and hematological malignancies<br>Participants with solid tumors and hematological malignancies will be included. No study treatment will be administered in this study. | Other: Screening Platform<br>* Eligible participants who qualify as per this screening protocol may be referred to evaluate adoptive cell therapy in participants with various malignancies, on a separate treatment trial. No study treatment will be administered in this screening study.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Human Leukocyte Antigen (HLA) genotypes (HLA-A*02:01, HLA-A*02:05, or HLA-A*02:06) |  | Up to 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adoptive T-cell therapy, Hematologic Malignancy, Human leukocyte antigen, Screening study, Solid Tumors, T-cell receptors