Peptide Vaccine and Temozolomide for Metastatic Melanoma Patients

Study Overview
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Brief Summary
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The aim of the study is to assess if treatment with IDO/Survivin peptide vaccine can enhance the efficacy of temozolomide chemotherapy in patients with metastatic malignant melanoma.

Detailed Description
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Secondarily to studying the efficacy of the treatment; the investigators examine if treatment with IDO/Survivin peptide can induce a measurable cellular T-cell response when the vaccine is given in combination with temozolomide treatment for melanoma patients.

Official Title
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Combination of IDO/Survivin Peptide Vaccine, GM-CSF, Imiquimod and Temozolomide Chemotherapy for Patients With Metastatic Malignant Melanoma

Conditions
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Malignant Melanoma

Intervention / Treatment
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* Drug: Chemotherapy: Temozolomide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological verified malignant melanoma Metastatic disease (brain metastasis allowed if asymptomatic) Evaluable disease recording to RECIST v. 1.1 Age > 18 years Performance status, PS=0, PS=1 or PS=2 Life expectancy > 3 months Adequate bone marrow function Leucocyte count > 2,5 * 109/L Granulocyte count > 1,5 * 109/L Thrombocyte count > 100 * 109/l Creatinine < 2,5 * UNL 130 micromol/L Adequate liver function ASAT < 100 U/L Bilirubin < 300 U/L S-hCG negative (fertile women) Written informed consent Inclusion at least 4 weeks after major abdominal surgery If radiotherapy for brain metastases prior to inclusion, then progressive disease proven by new brain MR-scan before inclusion Exclusion Criteria: Treatment with immune suppressors (ie. prednisone) not allowed Other malignancies 3 years prior to inclusion except benign skin lesions Severe medical condition, severe asthma, severe COL, severe heart- or diabetic disease Acute/Chronic infection with HIV, hepatitis or tuberculosis Known severe allergic reactions Former anaphylactic reactions Active autoimmune diseases Pregnant or nourishing women Psychiatric disease resulting in non-compliance Known allergic reactions towards Montanide, Imiquimod, Temozolomide or Leukine Simultaneously treatment with other experimental drugs Patients cannot be treated with chemotherapy, radiotherapy (except locally) or immunotherapy 14 days within inclusion.

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaccine+adjuvants+temozolomide treatment<br>Experimental arm | Drug: Chemotherapy: Temozolomide<br>* Vaccine: 250 microgram IDO5 peptide + 250 microgram Survivin peptide + 500 microL Montanide every 2nd week Adjuvants: 75 microgram GM-CSF + 1 application Imiquimod every 2nd week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical benefit rate (CBR) | Primary endpoint is clinical benefit rate defined as complete remission rate + partial response + stable disease for a minimum of 6 months plus assessment of time to progression (TTP). | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Indeolamine 2,3 dioxygenase, Survivin, Montanide, Imiquimod, GMCSF