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

Phase 1

• Conditions: Renal Cell Cancer; Advanced Renal Cell Cancer
• Interventions: Biological: peptide vaccine; Drug: Granulocyte Macrophage Colony Stimulating Factor; Drug: Montanide ISA-51

• Registration Number: NCT02429440
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2015-04-14
• Study First Submitted QC: 2015-04-23
• Study First Posted: 2015-04-29
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-14
• Last Update Posted: 2017-08-17
• Primary Completion: 2017-10
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Arm 1	peptide vaccine	Intradermal application of peptide vaccine in combination with Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)
Study Arm 2	peptide vaccine	Intradermal application of peptide vaccine with Montanide ISA-51
Study Arm 1	Granulocyte Macrophage Colony Stimulating Factor	Intradermal application of peptide vaccine in combination with Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)
Study Arm 2	Montanide ISA-51	Intradermal application of peptide vaccine with Montanide ISA-51

Primary Outcome Measures

Name	Time	Method
Tolerability	Day 0-365	Tolerability, as measured by number of Participants with Adverse Events

Secondary Outcome Measures

Name	Time	Method
Immune Response	Day 0-365	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.
All Cause Mortality	60 Months	All cause Mortality, as measured as length of Overall Survival
Progression-free Survival	36 Months	Progression-free Survival, as measured as time to radiographic progression