Adjuvant Antigen Specific Immunotherapy in Patients With Advanced Renal Cell Carcinoma Using Tumor Associated Peptides

Study Overview
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Brief Summary
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Clinical Phase I/II study to investigate the feasibility and tolerability of synthetic adjuvant peptide immunisation in combination with immune adjuvants (granulocyte macrophage colony stimulating factor; Montanide ISA-51) in patients with advanced renal cell cancer (RCC).

Official Title
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Adjuvant Antigen Specific Immunotherapy in Patients With Advanced Renal Cell Carcinoma Using Tumor Associated Peptides

Conditions
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Renal Cell Cancer, Advanced Renal Cell Cancer

Intervention / Treatment
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* Biological: peptide vaccine
* Drug: Granulocyte Macrophage Colony Stimulating Factor
* Drug: Montanide ISA-51


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Advanced renal cell carcinoma clinical stage T3 or T4, N0, M0 N+, M0 M1 (after complete metastasectomy) ECOG performance status 0 or 1 age >18 years at least 4 weeks since last administration of radiation- or chemotherapy Serum levels of bilirubin <2 mg/dl, creatinine<2mg/dl Exclusion Criteria: detectable distant metastasis in radiological imaging (M1) patients unable to consent severe cardiopulmonary disorder (NYHA >= 3) presence of secondary malignancy Immunosuppressive medication (last application of glucocorticoids > 4 weeks) seizure pregnancy simultaneous participation in other active or passive immunisation treatment

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Arm 1<br>Intradermal application of peptide vaccine in combination with Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) | Biological: peptide vaccine<br>* subcutaneous<br>Drug: Granulocyte Macrophage Colony Stimulating Factor<br>* intradermal<br>* Other names: GM-CSF;|
| Active Comparator: Study Arm 2<br>Intradermal application of peptide vaccine with Montanide ISA-51 | Biological: peptide vaccine<br>* subcutaneous<br>Drug: Montanide ISA-51<br>* subcutaneous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability | Tolerability, as measured by number of Participants with Adverse Events | Day 0-365 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All Cause Mortality | All cause Mortality, as measured as length of Overall Survival | 60 Months | 
| Progression-free Survival | Progression-free Survival, as measured as time to radiographic progression | 36 Months | 
| Immune Response | Immune Response, as as measured by in vitro and in vivo T cell response on day 0 and day 70. In selected cases additional immune response evaluation might be applicable. | Day 0-365 |