Subject has confirmed sufficient expression of NY-ESO-1 and/or LAGE-1a by reverse transcription polymerase chain reaction (RT-PCR) as determined by a central laboratory contracted by the Sponsor (this determination will also be made under a pre-enrollment screening ICF).
Tumor expression of NY-ESO-1 or LAGE-1 by immunohistochemistry (IHC) and/or reverse transcriptase polymerase chain reaction (RTPCR)
NY-ESO-1 positive by immunohistochemistry (IHC) utilizing commercially available NY-ESO-1 antibodies
No prior treatment with a hypomethylating agent, or previous exposure to DEC-205/NY-ESO-1 fusion protein CDX-1401 (CDX-1401)
NY-ESO-1 positive malignancy by immunohistochemistry (IHC) utilizing commercially available NY-ESO-1 antibodies
NY-ESO-1 positive malignancy by immunohistochemistry (IHC) utilizing commonly available NY-ESO-1 antibodies
Measurable metastatic cancer that expresses NY ESO-1 as assessed by one of the following methods: reverse transcriptase-polymerase chain reaction (RT-PCR) on tumor tissue, or by immunohistochemistry of resected tissue, or serum antibody reactive with ESO
For cohorts 1, 2 and 3 only: Patient's tumor must be positive by histological or molecular assay for NY-ESO-1, according to the screening algorithm; historical results may be used\r\n* For cohort 4, NY-ESO-1 results will be noted but NY-ESO-1 positivity is not required for eligibility
Measurable metastatic cancer or locally advanced refractory/recurrent malignancy including melanoma that expresses ESO as assessed by one of the following methods: reverse transcriptase-polymerase chain reaction (RT-PCR) on tumor tissue, or by immunohistochemistry of resected tissue, or serum antibody reactive with ESO
NY-ESO-1 positive malignancy by immunohistochemistry (IHC) utilizing commonly available NY-ESO-1 antibodies
Expression of one (1) or more of the following TAPAs: Sp17, AKAP-4, Ropporin, PTTG-1, Span-xb, Her-2/neu, HM1.24, NY-ESO-1 and MAGE-1, by either RT-PCR and/or immunocytochemistry, Western blotting or ELISA, in neoplastic cells and/or blood. For HER-2/neu expression, positive FISH results are acceptable.
Immunohistochemistry (IHC) results from tumor biopsy for NY-ESO-1 positive
Have received prior NY-ESO-1 therapy
Tumor expression of NY-ESO-1 (2+ staining or > 25%) by immunohistochemistry (IHC).
Prior administration of other NY-ESO-1 targeting immunotherapeutics.
Tissue available from primary and/or recurrent disease to evaluate tumor expression of NY-ESO-1 or PDL1 by immunohistochemistry (IHC) and/or reverse transcriptase-polymerase chain reaction (RT-PCR), and for measurement of DNA methylation
No requirement for tumor expression of NY-ESO-1
Patients with fully resected stage IIb through IV melanoma, with melanoma validated by histology or cytology, who have NOT received prior therapy\r\n* Patients may have had primary cutaneous, mucosal, or ocular melanoma or metastasis from an unknown primary site\r\n* Tissue should be submitted for evaluation of NY-ESO-1 expression and T-cell infiltrates; however, availability of tissue and/or positivity for NY-ESO-1 is not mandatory
Positive staining of the most recently resected tumor tissue with antibodies to 1 or more of the following: human melanoma black (HMB) 45 for glycoprotein (gp) 100, NY-ESO-1, and/or melanoma-associated antigen recognized by T cells (MART)-1
Positive staining of tumor tissue with antibodies to 1 or more of the following: human melanoma black (HMB) 45 for gp100, or cancer-testis antigen (NY-ESO-1)
Tumor specimen positive for NY-ESO-1 expression by IHC.
Prior administration of other NY-ESO-1-targeting immunotherapeutics.
Tumor specimen positive for NY-ESO-1 expression by IHC and/or RT-PCR. At least one tumor must be accessible and patients must consent for biopsies in Arms C and D.
Prior administration of other NY-ESO-1-targeting immunotherapeutics
Tumor histology consistent with melanoma tumor specimen positive for NY-ESO-1 expression by IHC and/or RT-PCR.
Prior administration of other NY-ESO-1-targeting immunotherapeutics.
NY-ESO-1 positive malignancy by immunohistochemistry (IHC) utilizing commonly available NY-ESO-1 antibodies
Patients must have confirmed expression of NY-ESO-1 and/or LAGE-1 by RT-PCR, immunohistochemistry or quantigene analysis. (This determination will be made under a pre-enrollment screening ICF)
Patient's tumor must be positive by histological assay for NY-ESO-1?²??T, according to the screening algorithm as described in Section 3.3.1. Positive expression is defined as ? 50% of cells that are 2+ and/or 3+ by immunohistochemistry
For patients enrolled to Phase II Cohort B: Previous administration of vaccine therapy targeting NY-ESO-1.
Measurable metastatic melanoma that expresses ESO as assessed by one of the following methods: reverse transcription polymerase chain reaction (RT-PCR) on tumor tissue, or by immunohistochemistry of resected tissue, or serum antibody reactive with ESO
Tumor expression of NY-ESO-1 or LAGE-1 antigen by IHC or RT-PCR, or evidence of seropositivity to NY-ESO-1 or LAGE-1.
Prior exposure to NY-ESO-1 vaccine.
Positive NY-ESO-1 expression by reverse transcription (RT)-polymerase chain reaction (PCR) and/or immunohistochemistry (IHC) will be required for entry, as determined by analysis at the trial central laboratory
Previous administration of vaccine therapy targeting NY-ESO-1
Patients must express NY-ESO-1 in their tumor by immunohistochemistry (IHC) (> 5%) prior to leukapheresis
Tumor expression of NY-ESO-1 by immunohistochemistry (IHC) and/or real-time polymerase chain reaction (RTPCR)
Patients may have received previous NY-ESO-1 vaccine therapy
NY-ESO-1 expression in tumor by immunohistochemistry (IHC) is not required prior to screening consent; however, patients must have NY-ESO-1 expression to proceed with the leukapheresis; additionally patients must also meet the following criteria to proceed with leukapheresis (any exceptions to this will require prior approval by the Apheresis director and Principal Investigator):
NY-ESO-1 positive by IHC (for this study, even a small level of positivity is acceptable); for patients with < 5% NY-ESO-1 by IHC positivity, the level of staining should be discussed with the patient and they should be informed that this will likely effect the efficacy of the therapy; this conversation must be documented in the patient's medical chart
Patients must have NY-ESO-1 specific cells already produced or in production; these cells may be either in the process of their final expansion (for fresh infusion) or expanded and frozen at the time of enrollment
Patients for whom we are unable to generate NY-ESO-1 specific cells
Subject's tumor (either the most recent archival specimen or a fresh biopsy) shows positive NY-ESO-1 expression defined as ?30% of cells that are 2+ or 3+ by immunohistochemistry. All samples must have been pathologically reviewed by an Adaptimmune designated central laboratory.
Patients must have proven positive tumor sample for NY-ESO-1 as follows:
Cancer/testis antigen 1B (NY-ESO-1) specific T cell therapy within 1 year of starting on the trial