Expression Analysis of Specific Markers in Non-small Cell Lung Cancer or Melanoma

Study Overview
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Brief Summary
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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
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This protocol posting has been updated due to a protocol amendment.

Official Title
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Analysis of the Expression of a Specific Set of Genes and Tumor Antigens in Patients With Non-small Cell Lung Cancer or Melanoma

Conditions
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Lung Cancer, Non-Small Cell

Intervention / Treatment
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* Procedure: Collection of tumor and blood samples


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ME1<br>Patients with cutaneous metastatic melanoma receiving dacarbazine or temozolomide as first line treatment | Procedure: Collection of tumor and blood samples<br>* Samples will be collected before and after standard treatment<br>|
| Other: ME2<br>Patients with cutaneous metastatic melanoma receiving first line treatment other than dacarbazine or temozolomide only | Procedure: Collection of tumor and blood samples<br>* Samples will be collected before and after standard treatment<br>|
| Other: ME3<br>Patients with cutaneous metastatic melanoma receiving any second-or higherline chemotherapy treatment | Procedure: Collection of tumor and blood samples<br>* Samples will be collected before and after standard treatment<br>|
| Other: ME4<br>Patients with cutaneous metastatic melanoma receiving local irradiation of cutaneous/subcutaneous tumor lesions | Procedure: Collection of tumor and blood samples<br>* Samples will be collected before and after standard treatment<br>|
| Other: ME5<br>Patients with cutaneous metastatic melanoma receiving local imiquimod | Procedure: Collection of tumor and blood samples<br>* Samples will be collected before and after standard treatment<br>|
| Other: NSC<br>Non-small cell lung cancer patients | Procedure: Collection of tumor and blood samples<br>* Samples will be collected before and after standard treatment<br>|
| Other: ME6<br>Patients with cutaneous metastatic melanoma receiving ipilimumab | Procedure: Collection of tumor and blood samples<br>* Samples will be collected before and after standard treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Before and after administration of standard of care treatment course, up to 3 months | 
| 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 | 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. | At 6 months after the initiation of the ipilimumab therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tumor antigen, biomarkers