Development of Immunological Assays for the Evaluation of Tumor Antigen Specific Immunity

Study Overview
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Brief Summary
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This study is a clinical study aiming at establishing immunological assays for the qualitative and quantitative evaluation of WT-1, Survivin and HPV16 E7-specific immune responses in cancer patients. Such a study will allow the development of suitable immunological tools to be used in assessing response in a subsequent phase I study aiming at evaluating therapeutic vaccine candidates targeting WT-1, Survivin and/or HPV16 E7-expressing tumors. In addition, this study will help defining the baseline cancer-associated immune responses in the selected patient population. Cervical and ovarian cancer patients, as well as leukemia patients, will be included in this study. WT-1, Survivin and HPV-specific immune responses will be monitored in these patients by ex vivo and cultured IFNg ELISpot as well as tetramer staining.

Official Title
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Phase 0 Study for the Development of Immunological Assays for the Evaluation of WT-1, Survivin and HPV16 E7 Tumor Antigens Specific Immune Responses in Cancer Patients

Conditions
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Ovarian Serous Adenocarcinoma, Undifferentiated Carcinoma of Ovary, Cervical Cancer, Cervical Intraepithelial Neoplasia, Grade 3, Acute Myeloid Leukemia, Chronic Myeloid Leukemia

Intervention / Treatment
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* Procedure: Blood Sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Specific Inclusion criteria For ovarian cancer patients: Histologically confirmed surgical diagnosis of high-grade serous (or undifferentiated) ovarian cancer For CIN3 and cervical cancer patients: Histologically confirmed diagnosis of CIN3 or cervical cancer For AML and CML patients: HLA-A2 positivity and diagnosis of AML or CML confirmed by bone marrow biopsy or peripheral blood Shared inclusion criteria No evidence of active progressive disease. For ovarian cancer patients, a woman with a rising CA125 and negative imaging is acceptable Age ≥ 18 yrs and < 70 yrs ECOG 0-2 Adequate hematologic assessment (results from the previous standard of care visit): Absolute neutrophil count (ANC) greater than or equal to 1.0 x 109/L Platelets greater than or equal to 100 x 109/L. Written informed consent Exclusion Criteria: Treatment with chemotherapy, radiation therapy, other immunotherapy or non-topical steroids within the past 3 weeks prior to initiation of the study. Immunosuppressive therapy (excluding topical steroids) for any other condition. Recurrent/progressive disease confirmed clinically, radiologically or histologically before entry into the study. (exclude versus inclusion criteria) Persistent fever (>24 hours) documented by repeated measurement or active uncontrolled infection in the last 4 weeks. Active autoimmune disease, including, but not limited to, SLE, MS, ankylosing spondylitis.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer patients<br>Patient with histologically confirmed diagnosis of cervical cancer or cervical intraepithelial neoplasia (grade 3) or of high-grade serous (or undifferentiated) ovarian cancer or patients with AML or CML confirmed by bone marrow biopsy or peripheral blood Not treated - prior standard of care therapy acceptable one blood sampling performed on the visit day | Procedure: Blood Sampling<br>* Sampling of 80mL of whole blood<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development and validation of ELISpot and tetramer assays for the detection of tumor-antigen specific T cell immune responses in cancer patients | Direct and cultured IFNg ELISpot as well as direct tetramer staining assays will be set up and qualified for the detection WT-1, survivin and HPV16 E7 specific immune responses in cancer patients | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterisation of WT1, Survivin and HPV16 E7 specific immune responses in cancer patients | Direct and Cultured IFNg ELISpot assays as well as tetramer staining assays will be used for the characterization of tumor specific immune responses in cancer patients | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV, Ovarian Cancer, Cervical Cancer, Leukemia, Immunity, WT-1, Survivin