Trial Outcomes & Findings for Expression Analysis of Specific Markers in Non-small Cell Lung Cancer or Melanoma (NCT NCT00685750)

Last Updated: 2019-06-20

Results Overview

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

Recruitment status

TERMINATED

Study phase

Target enrollment

88 participants

Primary outcome timeframe

Before and after administration of standard of care treatment course, up to 3 months

Results posted on

2019-06-20

Participant Flow

Participant milestones

Participant milestones
Measure	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	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	Melanoma 3 Group Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of any second-or higherline chemotherapy treatment	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	Melanoma 5 Group Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of local imiquimod	Melanoma 6 Group Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of ipilimumab	Non-Small Cell Group Non-small cell lung cancer patients nothing other than any standard of care treatment.
Overall Study STARTED	17	3	21	2	15	20	10
Overall Study COMPLETED	17	3	19	2	15	20	9
Overall Study NOT COMPLETED	0	0	2	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Melanoma 3 Group Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of any second-or higherline chemotherapy treatment	Non-Small Cell Group Non-small cell lung cancer patients nothing other than any standard of care treatment.
Overall Study Tumor sampling failure	1	0
Overall Study Patient didn't receive the treatment	0	1
Overall Study Eligibility criteria not fulfilled	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Melanoma 1 Group n=17 Participants Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of dacarbazine or temozolomide as first line treatment	Melanoma 2 Group n=3 Participants Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of first line treatment other than dacarbazine or temozolomide only	Melanoma 3 Group n=21 Participants Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of any second-or higherline chemotherapy treatment	Melanoma 4 Group n=2 Participants Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of local irradiation of cutaneous/subcutaneous tumor lesions	Melanoma 5 Group n=15 Participants Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of local imiquimod	Melanoma 6 Group n=20 Participants Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of ipilimumab	Non-Small Cell Group n=10 Participants Non-small cell lung cancer patients nothing other than any standard of care treatment.	Total n=88 Participants Total of all reporting groups
Age, Continuous	67.4 Years STANDARD_DEVIATION 12.1 • n=17 Participants	50.7 Years STANDARD_DEVIATION 12.5 • n=3 Participants	64.5 Years STANDARD_DEVIATION 11.5 • n=21 Participants	77.0 Years STANDARD_DEVIATION 5.7 • n=2 Participants	65.5 Years STANDARD_DEVIATION 13.5 • n=15 Participants	61.8 Years STANDARD_DEVIATION 16.7 • n=20 Participants	59.5 Years STANDARD_DEVIATION 9.7 • n=10 Participants	63.8 Years STANDARD_DEVIATION 13.3 • n=88 Participants
Sex: Female, Male Female	11 Participants n=17 Participants	3 Participants n=3 Participants	9 Participants n=21 Participants	0 Participants n=2 Participants	9 Participants n=15 Participants	11 Participants n=20 Participants	2 Participants n=10 Participants	45 Participants n=88 Participants
Sex: Female, Male Male	6 Participants n=17 Participants	0 Participants n=3 Participants	12 Participants n=21 Participants	2 Participants n=2 Participants	6 Participants n=15 Participants	9 Participants n=20 Participants	8 Participants n=10 Participants	43 Participants n=88 Participants
Race and Ethnicity Not Collected	—	—	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Before and after administration of standard of care treatment course, up to 3 months

Population: The analysis was performed on the Total Treated cohort.

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

Outcome measures

Outcome measures
Measure	Melanoma 1 Group n=17 Participants Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of dacarbazine or temozolomide as first line treatment	Melanoma 2 Group n=3 Participants Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of first line treatment other than dacarbazine or temozolomide only	Melanoma 3 Group n=21 Participants Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of any second-or higherline chemotherapy treatment	Melanoma 4 Group n=2 Participants Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of local irradiation of cutaneous/subcutaneous tumor lesions	Melanoma 5 Group n=15 Participants Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of local imiquimod	Melanoma 6 Group n=20 Participants Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of ipilimumab	Non-Small Cell Group n=10 Participants Non-small cell lung cancer patients nothing other than any standard of care treatment.
Number of Subjects With Expression of Tumor Antigens MAGE-A3 · Remained Positive	8 Participants	0 Participants	11 Participants	1 Participants	5 Participants	6 Participants	1 Participants
Number of Subjects With Expression of Tumor Antigens MAGE-A3 · Remained negative	7 Participants	0 Participants	0 Participants	0 Participants	5 Participants	6 Participants	5 Participants
Number of Subjects With Expression of Tumor Antigens MAGE-A3 · Turned Positive	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Expression of Tumor Antigens MAGE-A3 · Turned Negative	0 Participants	2 Participants	9 Participants	0 Participants	2 Participants	3 Participants	2 Participants
Number of Subjects With Expression of Tumor Antigens MAGE-A3 · Not tested	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Expression of Tumor Antigens MAGE-A3 · Invalid testing	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	3 Participants	2 Participants
Number of Subjects With Expression of Tumor Antigens NY-ESO-01 · Remained Positive	4 Participants	1 Participants	2 Participants	1 Participants	4 Participants	4 Participants	NA Participants NY-ESO-01 gene signature was not assessed in this group
Number of Subjects With Expression of Tumor Antigens NY-ESO-01 · Remained negative	9 Participants	1 Participants	14 Participants	0 Participants	6 Participants	11 Participants	NA Participants NY-ESO-01 gene signature was not assessed in this group
Number of Subjects With Expression of Tumor Antigens NY-ESO-01 · Turned Positive	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	NA Participants NY-ESO-01 gene signature was not assessed in this group
Number of Subjects With Expression of Tumor Antigens NY-ESO-01 · Turned Negative	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	NA Participants NY-ESO-01 gene signature was not assessed in this group
Number of Subjects With Expression of Tumor Antigens NY-ESO-01 · Not tested	2 Participants	0 Participants	2 Participants	1 Participants	2 Participants	1 Participants	NA Participants NY-ESO-01 gene signature was not assessed in this group
Number of Subjects With Expression of Tumor Antigens NY-ESO-01 · Invalid testing	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	3 Participants	NA Participants NY-ESO-01 gene signature was not assessed in this group

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Melanoma 1 Group n=17 Participants Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of dacarbazine or temozolomide as first line treatment	Melanoma 2 Group n=3 Participants Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of first line treatment other than dacarbazine or temozolomide only	Melanoma 3 Group n=21 Participants Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of any second-or higherline chemotherapy treatment	Melanoma 4 Group n=2 Participants Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of local irradiation of cutaneous/subcutaneous tumor lesions	Melanoma 5 Group n=15 Participants Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of local imiquimod	Melanoma 6 Group n=20 Participants Patients with cutaneous metastatic melanoma receiving nothing other than standard of care treatment consisting of ipilimumab	Non-Small Cell Group Non-small cell lung cancer patients nothing other than any standard of care treatment.
Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic Remained positive	4 Participants	0 Participants	4 Participants	0 Participants	4 Participants	6 Participants	—
Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic Remained Negative	9 Participants	0 Participants	7 Participants	0 Participants	3 Participants	5 Participants	—
Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic Turned Positive	0 Participants	1 Participants	2 Participants	0 Participants	4 Participants	2 Participants	—
Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic Turned Negative	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	4 Participants	—
Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic Not tested	2 Participants	0 Participants	6 Participants	1 Participants	3 Participants	0 Participants	—
Number of Subjects With a Pre-identified Gene Signature (GS) to the recMAGE-A3 Cancer Immunotherapeutic Invalid testing	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	3 Participants	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

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.