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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Tolerability
Tolerability, as measured by number of Participants with Adverse Events
Time frame: Day 0-365
All Cause Mortality
All cause Mortality, as measured as length of Overall Survival
Time frame: 60 Months
Progression-free Survival
Progression-free Survival, as measured as time to radiographic progression
Time frame: 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.
Time frame: Day 0-365
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