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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival
2015 (estimated)
No
Brian Rini, MD
Principal Investigator
Cleveland Clinic Taussig Cancer Institute
France: Agence Nationale de Sécurité du Médicament et des produits de santé
IMA901-301
NCT01265901
December 2010
April 2015
Name | Location |
---|---|
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |
IU Simon Cancer Center | Indianapolis, Indiana 46202 |
Karmanos Cancer Institute | Detroit, Michigan 48201 |
University of Cincinnati | Cincinnati, Ohio 45267-0502 |
Georgetown University Medical Center, Lombardi Comprehensive Cancer Center | Washington, District of Columbia 20007 |
Cleveland Clinic Taussig Cancer Institute | Cleveland, Ohio 44195 |
Cedars-Siani Medical Center, Samuel Oschin Comprehensive Cancer Institute | Los Angeles, California 90048 |
Kaiser Permanente Oncology Hematology Clinic | Denver, Colorado 80205 |
M.D. Anderson Cancer Center | Orlando, Florida 32806 |
Fred C. Buffett Professor of Medicine & Surgery Sections Hematology/Oncology & Urology University of Chicago | Chicago, Illinois 60637 |
North Central Cancer Treatment Group, Illinois Cancer Care | Peoria, Illinois 61615-7822 |
Weinberg Cancer Institute at Franklin Hospital | Baltimore, Maryland 21237 |
Clinical Research Alliance | Lake Success, New York 11042 |
UPMC Cancer Pavilion, University of Pittsburgh Cancer Institute, Division of Hematology / Oncology | Pittsburgh, Pennsylvania 15232 |
South Texas Oncology & Hematology, P.A., The Start Center For Cancer Care | San Antonio, Texas 78229 |