Phase 2, Randomized, Open Label, Multicenter Study of Intradermal IMA901 Plus GM-CSF With or Without Low Dose Cyclophosphamide Pre-treatment in Advanced Renal Cell Carcinoma Patients With Measurable Disease
This is a multicenter, open label, randomized phase 2 study which investigated the effect of
a second-line systemic treatment with IMA901 plus GM-CSF in RCC patients. Randomization was
done according to a pre-treatment with low-dose cyclophosphamide (CY). Secondary endpoints
comprised tumor response parameters.
The study population consisted of HLA-A*02-positive men or women with advanced RCC of the
clear-cell type classified as having a favorable or intermediate risk after first-line
systemic therapy for. Patients had to be aged 18 years or older, had at least have one
measurable tumor lesion and had have received first-line tyrosine kinase inhibitor or
cytokine systemic therapy for advanced disease, during or after which the patient had
experienced disease progression.
Patients in both arms received a total of 17 vaccinations with GM-CSF followed by IMA901
during the 9 month treatment period.
At screening baseline tumor status was assessed by CT or MRI. During the study tumor
assessments were performed every 6 weeks.
Immunomonitoring (T-cell responses to peptides contained in IMA901 and analysis of other
immune cell populations that may influence T-cell responses), serum levels of antibodies and
molecules with suspected influence on immune response were assessed on several occasions
during the study.
Safety assessment comprised continuous adverse event reporting, regular physical
examinations and regular assessments of vital signs, hematology, blood chemistry and urine.
A 12-lead ECG was performed at screening and at the end of the study. Pregnancy testing was
performed according to applicable legislation in the country where the trial was performed.
At the very least, women of childbearing potential had have to undergo a pregnancy test
during screening for the study, before the first dose was applied and at the end of the
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease control rate
after 26 weeks
Alexandra Kirner, PhD
immatics Biotechnologies GmbH
EudraCT Nr: 2006-006370-25