Metastatic Renal Cell Carcinoma Clinical Trial
Official title:
A Randomized, Controlled Phase III Study Investigating IMA901 Multipeptide Cancer Vaccine in Patients Receiving Sunitinib as First-line Therapy for Advanced/Metastatic Renal Cell Carcinoma
The primary objective of the phase III study is to investigate whether IMA901 can prolong
overall survival in patients with metastatic and/or locally advanced renal cell carcinoma
(RCC) when added to standard first-line therapy with sunitinib.
Secondary objectives include a subgroup analysis of overall survival in patients defined by a
certain biomarker signature, the investigation of progression-free survival, best tumor
response, safety, and immunological parameters.
This is a multicenter, open-label, randomized phase III study to investigate whether
therapeutic vaccination with IMA901, a mult-peptide cancer vaccine (TUMAP), can prolong
overall survival in patients with metastatic and/or locally advanced RCC when added to
standard first-line therapy with sunitinib (primary endpoint).
Secondary endpoints include a subgroup analysis of overall survival in patients who are
positive for a prospectively defined primary biomarker signature (identified as being
predictive for improved clinical outcome in IMA901-vaccinated patients in the previous phase
II study), progression-free survival (PFS), best overall response, cellular immunomonitoring
in a subset of patients, and safety. Safety analysis will be based on adverse events (AEs),
physical examinations, vital signs, hematology, clinical chemistry, urinalysis and ECG
changes.
Further endpoints include subgroup analyses of overall survival in patients who are positive
for further prospectively defined biomarkers (identified in the previous phase II study), and
exploratory screening of new biomarkers (to be investigated in patients' blood and paraffin
sections from tumor tissue) to predict better clinical outcome as response to vaccination
with IMA901. Biomarker sets will not be used for patient selection in this study.
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