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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
339
As per label.
Intradermal injection of GM-CSF as adjuvant.
One single low-dose i.v. infusion prior to the first vaccination
Overall survival
Time frame: 2015 (estimated)
Overall survival in biomarker-defined subgroup
Time frame: 2015 (estimated)
Progression-free survival
Time frame: 2014 (estimated)
Best tumor response
Time frame: 2014 (estimated)
Safety and tolerability
Time frame: continuously
Cellular immunomonitoring
Time frame: 2014 (estimated)
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Intradermal vaccinations with IMA901 vaccine.
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Cedars-Siani Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States
Kaiser Permanente Oncology Hematology Clinic
Denver, Colorado, United States
Georgetown University Medical Center, Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
M.D. Anderson Cancer Center
Orlando, Florida, United States
The University of Chicago Medicine
Chicago, Illinois, United States
North Central Cancer Treatment Group, Illinois Cancer Care
Peoria, Illinois, United States
IU Simon Cancer Center
Indianapolis, Indiana, United States
Weinberg Cancer Institute at Franklin Hospital
Baltimore, Maryland, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
...and 95 more locations