Lung Cancer, Non-Small Cell
Conditions
Keywords
tumor antigen, biomarkers
Brief summary
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.
Detailed description
This protocol posting has been updated due to a protocol amendment.
Interventions
PROCEDURECollection of tumor and blood samples
Samples will be collected before and after standard treatment
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient (male or female) is at least 18 years of age. * The investigator believes that the patient can and will comply with the requirements of the protocol. * The patient has given his/her written informed consent to take part in the study. * The investigator believes that it will be possible to obtain a tumor tissue sample of at least 3 mm3 before treatment and all required tumor tissues several weeks after the initiation of the treatment. * The patient has cancer in one of the following histological types, fulfilling all of the characteristics listed for the respective cancer type: Cutaneous Melanoma, unresectable stage III or stage IV • The patient has histologically documented unresectable stage III or stage IV metastatic cutaneous melanoma. AND • The patient is a candidate for one of the following treatments: * First-line chemotherapy with DTIC or TMZ as monotherapy \[group ME1\], * First-line chemotherapy with an agent other than DTIC/TMZ as monotherapy or a combination (that may, but need not, include DTIC, TMZ, IL-2 or IFNγ) \[group ME2\], * Second- or higherline chemotherapy with any agent or combination of agents (that may, but need not, include DTIC, TMZ, IL-2 or IFNγ ; i.e., systemic chemotherapy after isolated limb perfusion should be considered as second-line) \[group ME3\], * Palliative irradiation of skin lesion(s)/region, irrespective of what line of treatment is planned \[group ME4\], * Topical palliative treatment by imiquimod of skin lesion(s), irrespective of what line of treatment is planned \[group ME5\]. * First or higher line treatment with ipilimumab \[group ME6\]. NSCLC, any stage if the patient is eligible for neo-adjuvant chemotherapy with subsequent resection • The patient has NSCLC at any stage (as defined by the International Staging System) if the patient is eligible for neo-adjuvant chemotherapy with subsequent resection. AND • The patient is a candidate for chemo(radio)-therapy induction doublet neoadjuvant chemotherapy with platinum plus a second chemotherapy drug. \[Note: Induction radiotherapy is permitted.\] The recruitment of patients to the NSCLC group has been ended prematurely.
Exclusion criteria
* The patient has any family history of congenital or hereditary immunodeficiency. * The patient has in the two weeks before baseline received any of the following: * Chemotherapeutic agents, * Immune-modulating agents such as (but not confined to) IFN-α, IL-2, BCG and anti-cancer therapeutic vaccines, * Immunosuppressive agents such as corticosteroids \[except for prednisone, or equivalent, \<0.5 mg/kg/day (absolute maximum 40 mg/day, maximum duration of treatment three weeks), and inhaled and topical steroids, which are allowed\]. * The patient is currently receiving an anti cancer treatment in another clinical trial. However, if the patient has finished the drug administration phase of that trial and has entered the follow-up phase, this patient can be included.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Expression of Tumor Antigens | Before and after administration of standard of care treatment course, up to 3 months | 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 |
| Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Before and after administration of standard of care treatment course, up to 3 months | 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. |
| The Serum Proteome | 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. | 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. | After administration of standard of care treatment course | — |
| Number of Patients Responding to Treatment, by Best Clinical Response Type | At 6 months after the initiation of the ipilimumab therapy | 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. |
Countries
France, Germany, Italy, Sweden, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Melanoma 1 Group Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of dacarbazine or temozolomide as first line treatment | 17 |
| Melanoma 2 Group Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of first line treatment other than dacarbazine or temozolomide only | 3 |
| Melanoma 3 Group Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of any second-or higherline chemotherapy treatment | 21 |
| Melanoma 4 Group Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of local irradiation of cutaneous/subcutaneous tumor lesions | 2 |
| Melanoma 5 Group Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of local imiquimod | 15 |
| Melanoma 6 Group Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of ipilimumab | 20 |
| Non-Small Cell Group Non-small cell lung cancer patients nothing other than any standard of care treatment. | 10 |
| Total | 88 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Eligibility criteria not fulfilled | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Patient didn't receive the treatment | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Tumor sampling failure | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Melanoma 1 Group | Melanoma 2 Group | Melanoma 3 Group | Melanoma 4 Group | Melanoma 5 Group | Melanoma 6 Group | Non-Small Cell Group | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 67.4 Years STANDARD_DEVIATION 12.1 | 50.7 Years STANDARD_DEVIATION 12.5 | 64.5 Years STANDARD_DEVIATION 11.5 | 77.0 Years STANDARD_DEVIATION 5.7 | 65.5 Years STANDARD_DEVIATION 13.5 | 61.8 Years STANDARD_DEVIATION 16.7 | 59.5 Years STANDARD_DEVIATION 9.7 | 63.8 Years STANDARD_DEVIATION 13.3 |
| Race and Ethnicity Not Collected | — | — | — | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 11 Participants | 3 Participants | 9 Participants | 0 Participants | 9 Participants | 11 Participants | 2 Participants | 45 Participants |
| Sex: Female, Male Male | 6 Participants | 0 Participants | 12 Participants | 2 Participants | 6 Participants | 9 Participants | 8 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
Population: The testing was not be performed, because, as a consequence of the early study termination, no scientific value would have been brought and no patient would have benefited from it.
Primary
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
Population: The testing was not be performed, because, as a consequence of the early study termination, no scientific value would have been brought and no patient would have benefited from it.
Primary
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.
Time frame: At 6 months after the initiation of the ipilimumab therapy
Population: The analysis was performed on all the 25 subjects in the ME6 group that were tested for GS expression at Visit 1.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Melanoma 1 Group | Number of Patients Responding to Treatment, by Best Clinical Response Type | Not evaluable | 1 Participants |
| Melanoma 1 Group | Number of Patients Responding to Treatment, by Best Clinical Response Type | Stable Disease | 3 Participants |
| Melanoma 1 Group | Number of Patients Responding to Treatment, by Best Clinical Response Type | Partial response | 1 Participants |
| Melanoma 1 Group | Number of Patients Responding to Treatment, by Best Clinical Response Type | Progressive Disease | 9 Participants |
| Melanoma 1 Group | Number of Patients Responding to Treatment, by Best Clinical Response Type | Complete response | 0 Participants |
| Melanoma 2 Group | Number of Patients Responding to Treatment, by Best Clinical Response Type | Not evaluable | 2 Participants |
| Melanoma 2 Group | Number of Patients Responding to Treatment, by Best Clinical Response Type | Complete response | 0 Participants |
| Melanoma 2 Group | Number of Patients Responding to Treatment, by Best Clinical Response Type | Partial response | 0 Participants |
| Melanoma 2 Group | Number of Patients Responding to Treatment, by Best Clinical Response Type | Stable Disease | 4 Participants |
| Melanoma 2 Group | Number of Patients Responding to Treatment, by Best Clinical Response Type | Progressive Disease | 4 Participants |
| Melanoma 3 Group | Number of Patients Responding to Treatment, by Best Clinical Response Type | Stable Disease | 1 Participants |
| Melanoma 3 Group | Number of Patients Responding to Treatment, by Best Clinical Response Type | Complete response | 0 Participants |
| Melanoma 3 Group | Number of Patients Responding to Treatment, by Best Clinical Response Type | Progressive Disease | 0 Participants |
| Melanoma 3 Group | Number of Patients Responding to Treatment, by Best Clinical Response Type | Partial response | 0 Participants |
| Melanoma 3 Group | Number of Patients Responding to Treatment, by Best Clinical Response Type | Not evaluable | 0 Participants |
Primary
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
Population: The analysis was performed on the Total Treated cohort. Data was not collected for the subjects in Non-Small Cell Group.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Melanoma 1 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Remained positive | 4 Participants |
| Melanoma 1 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Remained Negative | 9 Participants |
| Melanoma 1 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Turned Positive | 0 Participants |
| Melanoma 1 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Turned Negative | 1 Participants |
| Melanoma 1 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Not tested | 2 Participants |
| Melanoma 1 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Invalid testing | 1 Participants |
| Melanoma 2 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Remained Negative | 0 Participants |
| Melanoma 2 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Turned Negative | 1 Participants |
| Melanoma 2 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Invalid testing | 1 Participants |
| Melanoma 2 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Remained positive | 0 Participants |
| Melanoma 2 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Turned Positive | 1 Participants |
| Melanoma 2 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Not tested | 0 Participants |
| Melanoma 3 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Invalid testing | 1 Participants |
| Melanoma 3 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Not tested | 6 Participants |
| Melanoma 3 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Turned Negative | 1 Participants |
| Melanoma 3 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Turned Positive | 2 Participants |
| Melanoma 3 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Remained positive | 4 Participants |
| Melanoma 3 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Remained Negative | 7 Participants |
| Melanoma 4 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Turned Negative | 1 Participants |
| Melanoma 4 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Remained Negative | 0 Participants |
| Melanoma 4 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Turned Positive | 0 Participants |
| Melanoma 4 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Invalid testing | 0 Participants |
| Melanoma 4 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Not tested | 1 Participants |
| Melanoma 4 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Remained positive | 0 Participants |
| Melanoma 5 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Remained positive | 4 Participants |
| Melanoma 5 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Not tested | 3 Participants |
| Melanoma 5 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Remained Negative | 3 Participants |
| Melanoma 5 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Turned Positive | 4 Participants |
| Melanoma 5 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Turned Negative | 1 Participants |
| Melanoma 5 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Invalid testing | 0 Participants |
| Melanoma 6 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Turned Negative | 4 Participants |
| Melanoma 6 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Turned Positive | 2 Participants |
| Melanoma 6 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Not tested | 0 Participants |
| Melanoma 6 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Invalid testing | 3 Participants |
| Melanoma 6 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Remained Negative | 5 Participants |
| Melanoma 6 Group | Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic | Remained positive | 6 Participants |
Primary
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
Population: The analysis was performed on the Total Treated cohort.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Melanoma 1 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Not tested | 2 Participants |
| Melanoma 1 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Turned Positive | 1 Participants |
| Melanoma 1 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Invalid testing | 1 Participants |
| Melanoma 1 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Remained Positive | 8 Participants |
| Melanoma 1 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Remained Positive | 4 Participants |
| Melanoma 1 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Turned Negative | 0 Participants |
| Melanoma 1 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Not tested | 1 Participants |
| Melanoma 1 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Invalid testing | 1 Participants |
| Melanoma 1 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Turned Negative | 0 Participants |
| Melanoma 1 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Turned Positive | 0 Participants |
| Melanoma 1 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Remained negative | 9 Participants |
| Melanoma 1 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Remained negative | 7 Participants |
| Melanoma 2 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Not tested | 0 Participants |
| Melanoma 2 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Not tested | 0 Participants |
| Melanoma 2 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Invalid testing | 1 Participants |
| Melanoma 2 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Turned Positive | 0 Participants |
| Melanoma 2 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Remained Positive | 0 Participants |
| Melanoma 2 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Turned Negative | 2 Participants |
| Melanoma 2 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Remained negative | 1 Participants |
| Melanoma 2 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Remained negative | 0 Participants |
| Melanoma 2 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Remained Positive | 1 Participants |
| Melanoma 2 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Turned Positive | 0 Participants |
| Melanoma 2 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Turned Negative | 0 Participants |
| Melanoma 2 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Invalid testing | 1 Participants |
| Melanoma 3 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Remained negative | 0 Participants |
| Melanoma 3 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Turned Negative | 1 Participants |
| Melanoma 3 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Invalid testing | 1 Participants |
| Melanoma 3 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Remained Positive | 2 Participants |
| Melanoma 3 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Not tested | 0 Participants |
| Melanoma 3 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Remained Positive | 11 Participants |
| Melanoma 3 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Invalid testing | 1 Participants |
| Melanoma 3 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Turned Positive | 1 Participants |
| Melanoma 3 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Remained negative | 14 Participants |
| Melanoma 3 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Turned Positive | 0 Participants |
| Melanoma 3 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Not tested | 2 Participants |
| Melanoma 3 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Turned Negative | 9 Participants |
| Melanoma 4 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Turned Positive | 0 Participants |
| Melanoma 4 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Not tested | 1 Participants |
| Melanoma 4 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Invalid testing | 0 Participants |
| Melanoma 4 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Remained Positive | 1 Participants |
| Melanoma 4 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Remained negative | 0 Participants |
| Melanoma 4 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Turned Positive | 0 Participants |
| Melanoma 4 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Turned Negative | 0 Participants |
| Melanoma 4 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Not tested | 1 Participants |
| Melanoma 4 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Invalid testing | 0 Participants |
| Melanoma 4 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Remained Positive | 1 Participants |
| Melanoma 4 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Remained negative | 0 Participants |
| Melanoma 4 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Turned Negative | 0 Participants |
| Melanoma 5 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Remained Positive | 4 Participants |
| Melanoma 5 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Not tested | 2 Participants |
| Melanoma 5 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Remained Positive | 5 Participants |
| Melanoma 5 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Remained negative | 5 Participants |
| Melanoma 5 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Remained negative | 6 Participants |
| Melanoma 5 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Invalid testing | 0 Participants |
| Melanoma 5 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Not tested | 2 Participants |
| Melanoma 5 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Turned Positive | 1 Participants |
| Melanoma 5 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Turned Positive | 1 Participants |
| Melanoma 5 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Invalid testing | 0 Participants |
| Melanoma 5 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Turned Negative | 2 Participants |
| Melanoma 5 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Turned Negative | 2 Participants |
| Melanoma 6 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Not tested | 1 Participants |
| Melanoma 6 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Turned Positive | 1 Participants |
| Melanoma 6 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Invalid testing | 3 Participants |
| Melanoma 6 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Remained negative | 6 Participants |
| Melanoma 6 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Remained Positive | 4 Participants |
| Melanoma 6 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Remained Positive | 6 Participants |
| Melanoma 6 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Turned Negative | 0 Participants |
| Melanoma 6 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Remained negative | 11 Participants |
| Melanoma 6 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Invalid testing | 3 Participants |
| Melanoma 6 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Turned Positive | 1 Participants |
| Melanoma 6 Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Not tested | 1 Participants |
| Melanoma 6 Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Turned Negative | 3 Participants |
| Non-Small Cell Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Not tested | 0 Participants |
| Non-Small Cell Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Remained negative | 5 Participants |
| Non-Small Cell Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Invalid testing | 2 Participants |
| Non-Small Cell Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Turned Negative | NA Participants |
| Non-Small Cell Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Turned Positive | NA Participants |
| Non-Small Cell Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Not tested | NA Participants |
| Non-Small Cell Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Turned Positive | 0 Participants |
| Non-Small Cell Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Remained Positive | 1 Participants |
| Non-Small Cell Group | Number of Subjects With Expression of Tumor Antigens | MAGE-A3 | Turned Negative | 2 Participants |
| Non-Small Cell Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Remained negative | NA Participants |
| Non-Small Cell Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Remained Positive | NA Participants |
| Non-Small Cell Group | Number of Subjects With Expression of Tumor Antigens | NY-ESO-01 | Invalid testing | NA Participants |
Primary
The Serum Proteome
Time frame: After administration of standard of care treatment course
Population: Proteome analysis on serum samples was not performed, because they, as a consequence of the early study termination, would not have added any scientific value and would not have benefited any individual patient.