This study intends to analyze the expression of specific sets of markers in tumor samples and in serum from patients with Non-Small Cell lung Cancer (NSCLC) or Stage III or IV melanoma. The data obtained in this study will be used to guide future development of immunotherapies for melanoma or NSCLC patients. Moreover, the analyses will contribute to definition of markers potentially predictive of clinical response to specific anticancer therapies.
This protocol posting has been updated due to a protocol amendment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
88
Samples will be collected before and after standard treatment
Number of Subjects With Expression of Tumor Antigens
The outcome presents the number of participants with expression of MAGE-A3 and NY-ESO-1 tumor antigens, after administration of standard of care treatment course compared to before administration
Time frame: Before and after administration of standard of care treatment course, up to 3 months
Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic
The outcome presents the number of participants with a pre-identified gene signature (GS) to the recMAGE-A3 cancer immunotherapeutic from before and after standard cancer treatment, for comparison.
Time frame: Before and after administration of standard of care treatment course, up to 3 months
The Serum Proteome
Time frame: After administration of standard of care treatment course
Correlation of Relevant Markers of the Pre-identified Gene-expression Signature as Measured by Immunohistochemical Methods and by Quantitative PCR.
Time frame: After administration of standard of care treatment course
Number of NSCLC Patients With Gene-expression Signature and Tumor Antigens in Distinct Concomitant Tumor Lesions Obtained at the Same Time From the Same Patient.
Time frame: After administration of standard of care treatment course
Number of Patients Responding to Treatment, by Best Clinical Response Type
This outcome was assessed for metastatic melanoma patients treated with ipilimumab, in order to explore the predictive value to clinical activity of pre-identified immune-related gene-expression signature, by evaluating the patient's best clinical response to this treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.
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GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Park Ridge, Illinois, United States
GSK Investigational Site
St Louis, Missouri, United States
GSK Investigational Site
Murray, Utah, United States
GSK Investigational Site
Dijon, France
GSK Investigational Site
Lille, France
GSK Investigational Site
Marseille, France
GSK Investigational Site
Marseille, France
GSK Investigational Site
Montpellier, France
GSK Investigational Site
Nantes, France
...and 24 more locations
Time frame: At 6 months after the initiation of the ipilimumab therapy